Clinical Trials

The purpose of this study is to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR), and to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to OS

This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

The purpose of this study is to identify melanoma patients that have a pattern or cycle when the immune system is more active in fighting cancer cells and see if treating melanoma at certain times in that cycle may be more effective.

The purpose of ths study is to evaluate a contrast-free ultrasound tool for the visualization and quantification of tumor microvessel morphologies, called quantitative high-definition microvessel imaging (qHDMI). This technology includes three components: (1) novel processing procedures to reveal small microvasculatures using high frame rate ultrasound imaging; (2) quantification procedures to analyze the morphology of the microvasculatures in terms of 10 parameters (e.g., tortuosity, branch angle, number of branch points, etc.); and (3) a classification method to automatically determine if the lesion is benign or malignant based on its morphological signature. 

The proposed technique is noninvasive, affordable, portable, and ...

The purpose of this study is to design, develop and assess the performance characteristics of a ddPCR assay for the detection of mutations associated with uveal melanoma. The performance characteristics of the ddPCR assay for the detection of ctDNA mutation in uveal melanoma patients will be assessed by comparing the mutation results obtained for the ddPCR assay on blood to those obtained on paired paraffin embedded tumors.

This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma.

The purpose of this study is to use therapeutic drug monitoring (trough plasma concentrations of dabrafenib, hydroxy dabrafenib, and/or trametinib) along with CYP3A4/CYP3A5 and CYP2C8 genotyping and BRAF mutation quantification will correlate with effectiveness (based on imaging studies) and/or toxicity (pyrexia, liver dysfunction, rash) in known melanoma patients.

The purpose of this study is to determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).
 

The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.

The purpose of this study is to compare the effectiveness of temozolomide to selumetinib for the treatment of patients who have melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, 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. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.

The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.

The purpose of this study is to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall survival (OS) and  to compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on progression free survival (PFS).

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.

The purpose of this study is to develop and maintain a registry database of all patients treated for a melanoma or a suspected metastatic lesion from a melanoma primary at MCF.

The purpose of this study is to demonstrate pharmacokinetic non-inferiority for nivolumab + relatlimab FDC SC (fixed-dose combination for subcutaneous administration) formulation versus nivolumab + relatlimab FDC IV formulation.

The purpose of this study is to select the optimal dose of naporafenib + trametinib to be studied in Stage 2 and to compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).

This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. 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. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients ...

The purpose of this study is to determine the safety profile and maximum tolerated dose (MTD) of VSV-IFNß-TYRP1 therapy when administered by IV and IT injection in patients with previously treated metastatic melanoma.

The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

The purpose of this study is to investigate how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E/K melanoma. Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.

The purpose of this study is to discover and validate DNA methylation-based markers that identify patients with metastatic melanoma based on the detection of such markers in patient blood with the ultimate goal of using blood-based multi-marker testing as a method of disease surveillance in melanoma patients.

The purpose of this study is to provide qualitative analysis of barriers to melanoma care in the United States Latinx Population.

A Postmarketing Prospective Cohort Study of Melanoma Patients Treated With IMLYGIC® (Talimogene Laherparepvec) in Clinical Practice to Characterize the Risk of Herpetic Infection Among Patients, Close Contacts, and Health Care Providers; and Long-term Safety in Treated Patients

The purpose of this study to compare MK-7684A to pembrolizumab with respect to RFS, and  to determine if MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.

The primary objective of the overall study is to determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect™ device, followed 30 minutes later by nivolumab IV on Day 1 of a 21-day cycle in patients with metastatic melanoma.

The purpose of this study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. It also aims to evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma and to evaluate the effectiveness of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. 

The primary objective of this study is to determine the safety profile of SX-682 alone and in combination with pembrolizumab in subjects with metastatic melanoma, including the maximum dose that can be administered until adverse effects prevent further dose increases (i.e., the MTD or recommended phase 2 dose), and the dose-limiting toxicity (DLT).

The secondary objectives are to evaluate the efficacy of SX-682 in combination with pembrolizumab on the basis of the objective response rate, the duration of response, and the rate of progression, and to characterize the single-dose and multidose pharmacokinetic (PK) profile of SX-682.

The purpose of this study is to:

1. Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
2. Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
3. Establish a repository of biological samples from patients with irAE and corresponding rheumatologic

This project will investigate whether the analysis of nucleic acids circulating in the blood from tumors can allow real-time monitoring of treatment response to targeted therapy and immunotherapy for patients who have stage IV metastatic melanoma.

This clinical trial studies individualized temozolomide (TMZ) in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as TMZ, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TMZ at different times, which are determined individually for each patient based on the phase (biorhythm) of the immune system response against the tumor may allow for a better drug response and may kill more tumor cells.

The purpose of this study is to explore the effectiveness and safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma.

The purpose of this study is to characterize ultrasound vibro-elastography features of ocular tumors.

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

The purpose of this study is to determine the kinetics of sPD-L1 removal and regeneration by plasma exchange in patients with melanoma.

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

This phase I trial studies the side effects and the best dose of dabrafenib in treating patients with solid tumors and kidney or liver dysfunction. Dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

This pilot trial studies the side effects and how well imiquimod and pembrolizumab work in treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving imiquimod and pembrolizumab may work better at treating melanoma.

The purpose of this study is to provide treatment with Nivolumab in combination with Ipilimumab and to assess the safety and tolerability of this combination in subjects who are anti-cytotoxic T lymphocyte associated antigen (CTLA)-4 treatment-naive and have unresectable or metastatic melanoma.

The trial is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered day 1 of a 21-day cycle in cycles 1-4 and then nivolumab 480 mg will be administered day 1 of a 28-day cycle for cycles 5-15 or until disease recurrence.

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.

The overall goal of the Olmsted County Health Skin Study is to describe the broader community with respect to knowledge of melanoma, attitudes about tanning, perceived risk of developing melanoma, and estimated risk of developing melanoma based on participant characteristics.

This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.

The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab

The sentinel lymph nodes in patients with melanoma are immunosuppressed and the investigators have shown this occurs early in the disease process. This regional nodal immunosuppression precedes nodal metastasis and may be required for nodal spread. Administration of GM-CSF has been used to alter the immune response to metastatic melanoma. The investigators propose to assess whether administration of a short course of GM-CSF preoperatively to patients about to undergo wide local excisions and sentinel lymph node dissection can alter the immune environment of the sentinel lymph node and restore an immune surveillance profile in the sentinel lymph node.

The purpose of this study is to evaluate the effectiveness and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1) vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma.

The purpose of this study is to validate an internally developed assay for the detection of BRAF V600E mutations in cfDNA from the peripheral blood of patients with melanoma.

This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.

The purpose of this study is to establish a tissue bank to collect patient tissue for genomic analysis, allowing identification of genomic signatures that predict response and failure to the individual therapy.  Once this is complete treatment will be directed based on the genomic signature of patients individual tumor.

The purpose of this 2-part study is to evaluate the safety and effectiveness of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of ...

The purpose of this 2-part study is to evaluate the safety and effectiveness of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of ...

This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab therapy. New diagnostic procedures, such as single-photon emission computed tomography (SPECT/CT), may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, may carry radiation directly to cancer cells and not harm normal cells. Giving 99mTc-HYNIC-IL2 with SPECT/CT may help find tumor growth in patients with stage IV melanoma

This study seeks to understand the treatment experiences and side effect reporting behavior of Stage III and IV melanoma patients who have undergone immunotherapy.  

The purpose of this study is to determine safety and measure biodistribution of  two imaging agents in patients with refractory or metastatic melanoma. This study will use [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) imaging. 

The purpose of this study is to evaluate the effectiveness and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma.

The purpose of this study is to use clinical, imaging, molecular, and epidemiological investigation toward the goal of providing new knowledge about ocular tumors that will be useful in understanding, diagnosing, monitoring, and suggesting new avenues of treatment. This study does not involve experimental treatment of any ocular tumor, but rather observation of tumor natural history or outcomes following standard of care therapy, associated systemic and ocular conditions, and basic research investigations to better understand tumor biomarkers and pathophysiology.

In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with Nivolumab in subjects with unresectable and metastatic melanoma.

The purpose of this study is to determine whether Nivolumab in combination with Relatlimab is more effective than Nivolumab by itself in treating unresectable Melanoma or Melanoma that has spread

The purpose of this study is to demonstrate that a neoadjuvant Daromun treatment followed by surgery and adjuvant therapy improves in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

The chimeric antigen receptor (CAR) T-cell therapy is a revolutionary cellular immunotherapy strategy that has transformed the treatment of B cell malignancies by engineering T cells to recognize B cell specific tumor markers; however, attempts to treat solid tumors with CAR T-cells have identified unique challenges that have rendered CAR T cells less effective against these tumors. Conventional CARs are designed to target tumor-associated antigens, but antigenic heterogeneity and the variable nature of surface antigen expression provide escape mechanisms for solid tumors from CAR T-cell attack. [1, 2] The solid tumor stroma acts as an immunosuppressive cloud that ...

The purpose of this study is to develop online education video-based modules to educate the Hispanic community. This will allow for the widespread, cost-effective scaling of our educational platform. Also, to demonstrate improvement in knowledge and practice of sun-smart behaviors. We will achieve this goal through a baseline, three-month, and one-year follow-up questionnaire examining melanoma knowledge and sun-safe behaviors (sunscreen use, sun protective clothing use, self-skin examination). Understanding the risks of melanoma and actively reducing one's risk of melanoma will be key to reducing the incidence of melanoma and improving overall survival in this population.

The purpose of this study is to evaluate combinations, using LXH254 as a backbone, which may help overcome intrinsic and acquired resistance to BRAF targeted therapy as well as offer new treatment options for NRAS melanoma patients.

This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, 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. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective than interferon ...

The overall purpose of this study is to understand the factors that increase susceptibility and expression of pancreatic cancer and melanoma in high risk families.  Individuals who are affected with pancreas cancer and melanoma, as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma, will be asked to participate. The participant will be asked to complete a survey about their health and family history of cancer and to give a blood sample for specific gene testing and storage for future research studies.

The purpose of this study is to analyze if  levels of glycoprotein non-metastatic melanoma protein B  be elevated  in patients with LAM..

The purpose of this study is to collect blood samples from Mayo Clinic patients with a diagnosis of Renal Cell Carcinoma (RCC) or Melanoma. The blood samples will be used to study immune cells which are the cells in our blood involved in protecting the body from disease and foreign invaders. The blood samples may also be used for future research of Renal Cell Carcinoma (RCC) or Melanoma at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

The purpose of this study is to understand the interplay of factors increasing susceptibility and expression of pancreatic cancer and melanoma to develop new diagnostic and chemopreventive regimens.

The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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 bevacizumab, 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 ...

The primary objective of this collaborative study is to collect biospecimens for the evaluation of internally developed assays designed to predict for and monitor response to currently available PD-1/PD-L1 inhibitors.

The purpose of this study is to evaluate JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.

The purpose of this study is to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life to back up evidence that less radical margins of excision may be just as safe.  

The purpose of this study is to Generate autologous iPSC in a manner compliant with requirements for future clinical use, and Reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

The purpose of this study is to look at the effects cancer and melanoma have on the immune cells found in lymph nodes.

The purpose of this study is to use new technology called Optical Transfer Diagnosis (OTD) to find if skin lesions are melanomas or non cancer. The research study team wants to see if the Balter Medical OTD technology will identify these lesions the same or better than a dermatologist.

The purpose of this study is to determine the overall rate of response of brain metastases in subjects with central nervous system (CNS) metastases due to metastatic melanoma with a BRAF V600 mutation who have relapsed or progressed from initial or systemic disease.

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The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

The FMD-ICI study will utilize animal and human data that finds that fasting may promote survival mechanisms and stress resiliency. The study aims to assess the impact that a restrictive calorie diet, mostly of fat and complex carbohydrates, mimicking fasting and increasing resiliency will have in protecting patients from the adverse effects of all advanced cancer treatments which require immunotherapy. By managing the adverse side effects of ICI treatments in select cancer patients, the study will assess the effect of immunotherapy plus the Xentigen fasting mimicking diet on adverse events rates, including immune-mediated colitis. Patients will be supplied with all their dietary requirements for 4 ...

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).

This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG−interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent ...

Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.

The purpose of this study is to evaluate the feasibility of molecular characterization based on tumor mutational burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study. Also, to evaluate the feasibility of molecular characterization based on TMB and gene expression profiling (GEP) (for TIS - tumor inflammation signature) for stratification in the overall study (Stage I and Stage II). Additinoally, to evaluate the effectiveness by overall response rate (ORR – defined as confirmed and unconfirmed partial responses plus complete ...

The purpose of this study is to determine the safety and tolerability of entinostat used in combination with pembrolizumab in patients with Non-small Cell Lung Cancer. Additionally the purpose of the study is to assess how effective entinostat and pembrolizumab are in combination in patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer

Drug monitoring of Pembrolizumaband Nivolumab for determining the pharmacokinetic (PK) profile of these medications and  to provide information for dose adjustments to guide physicians in the future.

The primary purpose of this study is to standardize the collection of demographic, clinical, and imaging data, and biosamples for a large high-risk familial Pancreatic Ductal Adenocarinoma (PDAC) cohort at consortium clinical cancer centers, worldwide.

The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

The purpose of this study is to evaluate the safety, tolerability and effectiveness of HBI-8000 when combined with a standard dose and regimen of nivolumab.

The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.

THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.

The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.

The overall goal of this pilot study is to assess initial quality and feasibility of a novel protoype TBP system that may be used in the future for accurate and accessible skin cancer screening called Skinmap. Skinmap’s automatic anatomical registration will be sufficient to permit accurate alignment of baseline overlays on current imagery for visual and automated detection of changes 1mm or greater on 95% of exposed skin in baseline and current image sets. The teams of Triangulate Labs and Mayo Clinic Enterprise Dermatology propose to validate, refine, and explore the clinical utility of Skinmap.

The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. Currently the study is enrolling only to the HNSCC cohort.

The ultimate goal of this biobank will be to provide the resource to initiate an exploration of human saliva as a potential liquid biopsy for cancer detection and surveillance.

The purpose of this study is to develop a biorepository of blood samples  from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies. 

The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.

This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access ...

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.

The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.

The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.

The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.

GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.