Clinical Trials

The purpose of this study is to evaluate different strategies of cardiovascular therapy with carvedilol aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.

In this study, we propose a new way of giving chemotherapy, called Adaptive Therapy (AT) using capecitabine. The goal is to prove feasibility as well as safety of this approach. We will test adaptive therapy in 35 metastatic breast cancer patients diagnosed with ER+ disease but for whom endocrine therapies have failed and use of chemotherapy is appropriate. We will recruit participants at Mayo Clinic Arizona. Chemotherapy will be given orally in an adaptive fashion, which means we will adjust the dose of the chemotherapy according to the response of the tumor. Response is measured by imaging done ...

The purpose of this research is to determine if previously adding a medication by the name of bevacizumab to the current standard chemotherapy of cancer-reducing medications, namely doxorubicin, cyclophosphamide and paclitaxel, reduces the risk of recurrence (called disease-free survival) compared to standard chemotherapy alone.

The purpose of this study is to continue with a long term follow-up of previously enrolled people treated with doxorubicin-cyclophosphamid followed by paclitaxel or docetaxel for axillary node-positive or high risk node-negative breast cancer. 

The purpose of this study is to evaluate T cell and antibody immunity in patients with HER2+ breast cancer who will receive trastuzumab with standard chemotherapy in order to address whether the immunity is associated with the patient’s response to treatment.

The purpose of this study is to describe changes in GI inflammation and the GI microbiome profile in women with breast cancer throughout chemotherapy. Also, to examine how GI inflammation and GI microbiome changes influence symptom experience is used above  in women with breast cancer receiving chemotherapy.

The purpose of this study is to compare the effectiveness of two different combinations of chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

The purpose of this study is to directly address PM, chemotherapy has been applied intra-peritoneally through a variety of methods, the most common being heated intra-peritoneal chemotherapy (HIPEC) at the time of cytoreduction surgery (CRS) for patients who qualify.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

The purpose of this study is to evaluate an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.

This is a prospective, pilot, single arm study to evaluate the incidence of IIC in patients with solid malignancies receiving VSL#3 and ICIs. Given the fact that the effects of over-the-counter probiotics in reducing the risks of IIC remains largely unknown. Given that this is a small pilot study to generate preliminary data, there will be no randomization in this trial. The results of this trial will provide a foundation for the future development of larger definitive randomized controlled trials. Patients with solid malignancy who will be receiving ICI as per standard of care will be enrolled in ...

The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (t rastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 wee ks. Anticipated time on study treatment is 52 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).

This phase II trial studies how well FASN inhibitor TVB-2640 and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body. FASN inhibitor TVB-2640 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Endcocrine therapy helps reduce ...

RATIONALE: Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving brostallicin together with cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving brostallicin together with cisplatin works in treating patients with metastatic breast cancer.

The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.

The purpose of this study is to evaluate how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent).

The purpose of this study is to offer pre-approval drug access of iniparib  combined with gemcitabine and carboplatin, in order to provide potential clinical benefit to patients who have ER-, PR-, and HER2-negative metastatic breast cancer.

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...

This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with triple-negative breast cancer and/or BRCA mutation-associated breast cancer that has come back or has or has not spread to the brain. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin is more ...

The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.

The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.

RATIONALE: Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are more effective than a placebo in preventing peripheral neuropathy caused by ixabepilone.

PURPOSE: This randomized phase III trial is studying calcium given together with magnesium to see how well it works compared with a placebo in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer.

The long-term goal of this study is to alleviate the occurrence of CIN and fatigue and to improve chemotherapy treatment outcomes. The identification of associations between fatigue, CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie patient symptom experience. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate fatigue and CIN.

The purpose of this study is to prospectively evaluate the patient-reported outcomes data of T-DM1 induced peripheral neuropathy like prior research focused on paclitaxel-, paclitaxel/CBDCA-, oxaliplatin-, and cisplatin-induced peripheral neuropathy, to better understand the similarities and differences of chemotherapy-induced peripheral neuropathy (CIPN) symptoms caused by different agents, their pathogenesis, and impacts.

The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)

The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive ...

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, ...

This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.

This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.

The purpose of this study is to see if anti-HER2 treatment be safely stopped in patients with HER2-positive metastatic breast cancer (MBC) that have had exceptional response to treatment. Exceptional response" is considered as cancer progression being controlled for three years or more since starting anti-HER2 treatment.

The purpose of this study is to evaluate how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better ...

This research study is studying Ruxolitinib as possible treatment for Inflammatory Breast Cancer (IBC). The Following drugs will be use in combination with Ruxolinitinib. - Paclitaxel (also called Taxol) - Doxorubicin also called Adriamycin - Cyclophosphamide, also called Cytoxan

This project will investigate whether ctDNA analysis in newly diagnosed stage I, II, III breast cancer patients treated with neoadjuvant systemic therapy can predict pathological Complete Response (pCR).

The purpose of this study is to determine if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body ...

This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by ...

This is a randomized Phase 2 study of novel SEQUEnced immunotherapy (pembrolizumab) with anti-angiogenesis and chemotherapy in advanced gastric and gastroesophageaL junction (GEJ) adenocarcinoma (SEQUEL) designed to to evaluate the best overall response rate (BORR) of combined ramucirumab (RAM) plus paclitaxel (+/- pembrolizumab) following induction pembrolizumab (PEM) in patients with advanced gastric and GEJ adenocarcinoma.

The purpose of this study is to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

The purpose of this study is to determine how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor ...

The purpose of this study is to evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) or progression-free survival (PFS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.

The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.   

Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years) 

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually for each cohort.

The purpose of this study is to compare the effectiveness of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that is metastatic (spread to other parts of the body), has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR), has a certain type of abnormal gene called "BRAF," and has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take ...

The primary purpose of this study is to evaluate the progression free survival (PFS) of advanced pancreatic cancer patients with germline BRCA1 or BRCA2 mutations treated with olaparib + pembrolizumab compared to olaparib alone as maintenance therapy.

The purpose of this study is to determine how well cytarabine and idarubicin or daunorubicin with or without pembrolizumab work in treating patients with newly-diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving induction chemotherapy with pembrolizumab may work ...

The purpose of this study is to characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in prospectively collected samples from breast cancer patients.   

Breast cancer patients are more than three times at risk for developing congestive heart failure (CHF), compared with patients who did not have cancer. The increased risk of HF is observed as early as one year from diagnosis of cancer and overall, 7% of patients develop CHF (median follow-up 8.5 years) 

The purpose of this study is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have ...

The purpose of this study is to determine if Brain Natriuretic Peptide (NT-pro-BNP) values increase over time in breast cancer survivors and correlate with cardiac dysfunction. This study will define the average NT-pro-B-natriuretic peptide values in female breast cancer patients 1, 2, 3, 4, and 5 years out from anthracycline-based chemotherapy.

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill ...

The purpose of this study is to collect and correlate the data from various cardiovascular risk asessments to successfully measure the risk of heart toxicity in patients receiving chemotherapy for breast cancer.

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

The purpose of this study is to determine whether lenalidomide enhances the activation potential of NK cells derived from Hodgkin’s lymphoma patients. The study also aims to determine if lenalidomide treated NK cells are more efficient in killing CD30+ tumor cells  (cancer cell lines) in combination with an investigational agent (AFM13, CD30/CD16a mAb, Affimed Therapeutics, Germany), which engages both the CD30+ tumor cell and CD16a+ NK cells.

The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.

The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.

The purpose of this study is to assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone.

The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes (defined by mass cytometry) are associated with pathologic complete response (pCR) after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.

The purpose of this study is to evaluate different strategies of cardiovascular therapy with Carvedilol, aiming to reduce the incidence of left ventricular ejection fraction (LVEF) decline and heart failure (HF) in patients undergoing curative intent Trastuzumab for breast cancer.

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This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)

This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression ...

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

This is a randomized, double-blinded study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.

This randomized Phase III, multicenter, open-label study is designed to evaluate the safety and efficacy of atezolizumab in combination with carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants will be randomized in a 2:1 ratio to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) or Arm B (Nab-Paclitaxel + Carboplatin).

The purpose of this study is to determine dose escalation of paclitaxel administered as Oraxol in combination with Pembrolizumab, and dose expansion to assess the ORR per Response Evaluation Criteria in subjects with advanced Solid Tumors, Urothelial Carcinoma, Gastric cancer, Gastro-esophageal cancer, and Non-small cell lung cancer.

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

The purpose of this study is to evaluate whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression, is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of ...

The purpose of this study is to evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment.

This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer ...

The primary purpose of this study is to assess the safety and tolerability of Niraparib or Olaparib in combination with RP-3500, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 in combination with Niraparib or Olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.

The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.

The purpose of this study is to assess the impact of pharmacist consultation in patients receiving first dose, first cycle intravenous cancer treatment on patient understanding of the cancer treatment, adverse drug events, and adherence. Additionally, this study will report the frequency of healthcare utilization for side effect management.

This multicenter, randomized, open-label study will evaluate the efficacy and safety of atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in patients with previously untreated locally advanced or metastatic renal cell carcinoma. Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab alone (until disease progression), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progression, patients in Arms B and ...

In patients with breast cancer which has metastasized to the lymph nodes under the arm, treatment involves marking one of the metastatic nodes at the time of needle sampling for later removal after months of systemic therapy before surgery. When patients respond well to systemic therapy, the marked node can be hard to find by ultrasound, the imaging modality of choice. Mayo has designed a marker that is conspicuous by ultrasound and has shown short-term safety and good performance in a Phase 0 Clinical Trial. This study investigates the hypothesis that the Mayo marker will be safe, detectable by ultrasound, and minimally ...

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.

The purpose of this study is to compare the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery ...

AALL1731 is a group-wide risk-stratified trial for children with newly diagnosed B-ALL and localized B-lymphoblastic lymphoma (B-LLy) that will test if the addition of blinatumomab to standard chemotherapy in patients with NCI SR B-ALL at highest risk for relapse will improve disease-free survival (DFS). Risk stratification will be determined by traditional prognosticators (tumor genetics, extent of extramedullary involvement, early response to therapy as determined by flow cytometry) combined with the new DNA-based MRD detection technology of high throughput sequencing (HTS) of the immunoglobulin heavy chain (IgH).

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

This study is being done to gather information. The study will provide important information related to the safety and the effect of the vaccine on a patient's immune system. What researchers learn from this study could possibly be used in the future to prevent or delay recurrence of breast or ovarian cancers.

The purpose of this study is to evaluate whether the combination of durvalumab plus lurbinectedin can increase 6 month progression-free survival, in patients with extensive stage small cell lung cancer who have progressed after treatment with an initial combination of chemotherapy and immunotherapy.

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

The purpose of this study is to evaluate whether the reduction from baseline in circulating tumor DNA at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + Standard of Care (SOC) therapy.

RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as lenalidomide and dexamethasone also work in different ways to kill tumor cells or stop them from growing. Giving elotuzumab together ...

This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

The purpose of this study is to determine how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs ...

The purpose of this study is to determine the response rate of the combination of Pemetrexed and Pembrolizumab in patients with recurrent or metastatic salivary gland cancer (R/M SGC).

This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab ...

The purpose of this study is to assess the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Drugs used in chemotherapy, such as gemcitabine, work in different ways by stopping the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine ...

The primary objectives of this study are to evaluate safety/tolerability and immunogenicity of IMU-201 as monotherapy and in combination with an immune checkpoint inhibitor (ICI) or an ICI and chemotherapy in participants with advanced NSCLC tumors that are positive for PD-L1, and to identify the Optimal Biological Dose (OBD) of IMU-201 as monotherapy and in combination with an ICI, or an ICI and chemotherapy, in participants with advanced NSCLC tumors that are positive for PD-L1.

The purpose of this study is to evaluate how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with trastuzumab, pertuzumab, and atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ...

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.

PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus works in treating patients with breast cancer.

This study is being reopened with Mayo IRB for long-term follow-up data purposes only. The initial study IRB# 12-009536 was "completed" prematurely as not all data collection activities had been completed. This study was always separately filed in Rochester and Mankato with two different PIs. Rochester is still open and Mankato was completed prematurely.

The purpose of this study is to evaluate combining endocrine therapy with CDK4/6 inhibition along with trastuzumab in ER+/ human epidermal growth factor receptor 2 (HER2)+ early stage breast cancer in order to influence estrogen receptor (ER) signaling.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer.

PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.

The purpose of this study is to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

The purpose of this study is to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.

The purpose of this study is to test the safety, side effects, and best dose of ASTX727 when given together with paclitaxel and pembrolizumab in patients with triple-negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). 

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.

PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

The purpose of this study is to evaluate how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.

The purpose of this study is to assess the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab for treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.

To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible and safe (as defined in Section 11.1) for patients with resectable malignant pleural mesothelioma.

a. To evaluate progression free survival (both by RECIST 1.1 and also using a Modified RECIST for Pleural Tumors) in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

b. To evaluate overall survival in patients with resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance atezolizumab.

c. ...

This partially randomized phase III trial studies isotretinoin with monoclonal antibody Ch14.18, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or deliver tumor-killing substances to ...

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.

The purpose of the phase 1 portion of this research study is to find out more about the side effects of belantamab and what doses of belantamab are safe for people when combined with lenalidomide and daratumumab, and to find the right dose for the phase 2 portion of the trial. 

This trial is exploring the use of a new drug called belantamab to be used in combination with daratumumab and lenalidomide and not using the same doses of dexamethasone as has been done with previous combinations. Belantamab is an anti-B-cell maturation antigen (BCMA) antibody-drug conjugate. This ...

The purpose of this study is to determine the safety and tolerability of personalized neoantigen peptide administered in combination with pembrolizumab to patients with advanced solid tumors. Patients' tumors will be sequenced during a pre-registration component or will have had successful sequencing pre-study. A personalized neoantigen peptide vaccine containing up to 20 unique peptides will be manufactured for each qualifying patient based on the results.

The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer.

The primary purpose of this study is to conduct a safety lead-in phase that identifies the safe recommended phase II dose for combination tazemetostat and MK-3475 (pembrolizumab) in patients with advanced urothelial carcinoma.

The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.

The purpose of this study is to evaluate appropriate dosage of FT516 as monotherapy in acute myeloid leukemia (AML), and in combination with CD20 directed monoclonal antibodies, in B-cell lymphoma. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-sepcific cohorts.

The purpose of this trial is to investigate the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.

This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), and non-small-cell lung cancer (NSCLC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established. In the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment ...

This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on ...

There is evidence that mindfulness-based interventions (MBIs) such as meditation, mindfulness-based stress reduction (MBSR) and yoga might improve Quality of Life (QOL) and reduce stress in breast cancer survivors. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress. The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy (usually 4-5 months) at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women ...

The purpose of this trial is to evaluate how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...

The purpose of this study is to anayze the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy ...

The purpose of this study is to determine how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ...

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that ...

The purpose of this study is to evaluate immune profile of Acute Myeloid Leukemia (AML) patients receiving Venetoclax plus Azacitidine induction chemotherapy.

The goal of this clinical research study is to learn how often breast cancer recurs (returns after treatment) in the breast in patients who have been treated with chemotherapy and have had follow-up radiation therapy (but not surgery) and are in complete remission (no evidence of disease). This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. The study doctor can explain how radiation therapy is designed to work. About 120 participants will be enrolled on this multicenter study. Up to 90 may take part at MD Anderson.

The purpose of this study is to assess the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement and that has not responded to previous treatment. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or ...

The purpose of this study is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory (R/R) multiple myeloma (MM), or immunoglobulin light chain (AL) amyloidosis, and to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT) and the maximum tolerated dose (MTD and recommended phase II dose (RP2D of APG2575 in combination with Daratumumab/Lenalidomide/dexamethasone (DRd) in patients with relapsed/refractory (R/R) multiple myeloma (MM).

The purpose of this study is to compare immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin, vinblastine, and dacarbazine, work ...

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, ...

The purpose of this study is to compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation ...

This phase II trial studies how well ixazomib citrate, lenalidomide, dexamethasone, and daratumumab work in treating patients with newly diagnosed multiple myeloma. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may block cancer growth in different ways by targeting certain cells. Giving ixazomib citrate, lenalidomide, dexamethasone, and daratumumab ...

The purpose of this study is to evaluate how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with ...

The purpose of this study is to show how well lenalidomide and dexamethasone work with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients ...

The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.

Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC ...

The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.

The purpose of this study is to apply new microvasculature imaging for differentiation of breast lesions, and prediction of response to preoperative chemotherapy.

The primary purpose of this study is to examine the effects of abemaciclib on the CD8/FOXP3 ratio in chemotherapy-resistant triple negative breast cancer (TNBC) patients following neoadjuvant chemotherapy.

The purpose of this study is to develop a breast cancer survivor (BCS) multiscale omics database that includes a complete fecal metagenome (gut microbiome) and fecal metabolome characterization. 

The purpose of this study is to compare three different combination chemotherapy regimens and evaluate how well they work in treating women who have undergone surgery for node-positive breast cancer. Drugs used in chemotherapy, such as docetaxel, doxorubicin, cyclophosphamide, paclitaxel, and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any remaining tumor cells.

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

The purpose of this trilal is to study a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast cancer.

The purpose of this study is to test the validity of durvalumab and VEGF inhibitor therapy to enhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.

The purpose of this study is to compare the effectiveness of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

The purpose of this study is to determine how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer.

The purpose of this study is to evaluate whether a reduction in the dose of consolidation radiation therapy (RT) in patients who achieve a negative post-chemotherapy PET-CT scan following 3 to 6 cycles of chemoimmunotherapy, will be associated with a low risk of in-field failure.

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .

The purpose of this study is to compare and identify different forms/regimens of chemotherapy/hormone therapy in breast cancer patients who underwent mastectomy and subsequent immediate breast reconstruction (tissue expander or direct-to-implant). Subsequently, correlate these findings to assess overall surgical and clinical outcomes.

This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.

The primary purpose of this study is to compare overall survival between two treatment arms, with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm, in post-autologous transplant multiple myeloma (MM) patients.

This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.

The purpose of this study is to assess the antitumor effectiveness and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and ...

The purpose of this study is to evaluate efficacy as measured by the disease control rate (CMR, PMR, and NMR) by Lugano 2014 PET-CT based assessment after 2 cycles of therapy.

The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.