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67652000PCR3002:A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE) (AMPLITUDE)
Scottsdale/Phoenix, Ariz.
The objectives of this study are to determine if Niraparib, Abiraterone Acetate (AA), and Prednisone compared with AA and Prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated mCSPC provides superior effectiveness in improving radiographic progression-free survival (rPFS), to assess the clinical benefit of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC, to characterize the safety profile of niraparib, AA, and prednisone compared with AA and prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.
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Analysis of Circulating Tumor Nucleic Acids to Monitor Treatment Response in Patients with Metastatic Melanoma
Scottsdale/Phoenix, Ariz.
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.
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PT-112-101, A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Patients with Advanced Solid Tumors and Subsequent Expansion Cohorts
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the maximum tolerated dose, and evaluate its safety, tolerability, preliminary clinical effects, and drug/body interactions.
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20200040: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager Tarlatamab in Subjects with De Novo or Treatment Emergent Neuroendocrine Prostate Cancer (DeLLpro-300) (AMG 757 202000040)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and tolerability of AMG 757, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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A Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Single Agent and In Combination With Enzalutamide in Subjects With Metastatic Castrate-Resistant Prostate Cancer
Scottsdale/Phoenix, Ariz.
This study consists of two phases: Dose Escalation (Phase 1b) and Dose Expansion (Phase 2) The Dose Escalation phase will evaluate the safety and tolerability of GS-5829 as a single agent and in combination with enzalutamide, as well as determine the maximum tolerated dose (MTD) of GS-5829 as a single agent and in combination with enzalutamide in participants with metastatic castrate-resistant prostate cancer (mCRPC). The Dose Expansion phase will evaluate the following: - In group 1, the efficacy of GS-5829 as a single agent in participants with mCRPC who have progressed while receiving enzalutamide (may have also received abiraterone) - In group 2, the efficacy of GS-5829 combined with enzalutamide in participants with mCRPC who have progressed while receiving treatment with abiraterone (may not have previously received enzalutamide) - In group 3, the efficacy of GS-5829 combined with enzalutamide in participants with mCRPC who have had Prostate Specific Antigen (PSA) progression, but not radiographic progression, while receiving treatment with enzalutamide (participants may have also previously received abiraterone)
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A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer
Scottsdale/Phoenix, Ariz.
The purpose of this study determine if treatment with sequential high dose testosterone and enzalutamide (STE) administered according to two different schedules will improve progression free survival (PFS) compared to enzalutamide (Enza) in men with metastatic castrateresistant prostate cancer (CRPC) post-treatment with abiraterone (Abi).
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MC210504 Phase II trial of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (HP) plus Enzalutamide for the Treatment of Selected Patients with Metastatic Castration-Resistant Prostate Cancer (TraPPer) (TraPPer)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
Patients with castration-resistant prostate cancer have few options. This study is designed to see if the combination of pertuzumab-trastuzumab-hyaluronidase plus enzalutamide has an effect on castration-resistant metastatic prostate cancer
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Phase 2 Multiple-Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapies in Selected Subjects With Metastatic Castration-Resistant Prostate Cancer
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.
Closed for Enrollment
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64091742PCR3001 A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer (MAGNITUDE)
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo.
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A Modular Phase 2a Multicentre Open-Label Study to Investigate DNA-damage Response Agents (or Combinations) in Patients With Advanced Cancer Whose Tumours Contain Molecular Alterations (PLANETTE) (PLANETTE)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to investigate the effectiveness, safety and tolerability of DNA-damage Response Agents (or Combinations), in participants with advanced/metastatic solid malignancies whose tumours contain molecular alterations.
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A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.
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A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab (PAVE-1)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This is a Phase 1b/2a, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) of PT-112 in the combination as avelumab will be administered at a flat dose of 800 mg. The trial will evaluate the PK (pharmacokinetic) effects of PT-112 and the safety and tolerability of the combination as well as preliminary clinical effects. The Dose Confirmation Phase will consist of two additional cohorts in patients with non-small cell lung cancer or urothelial carcinoma who will be treated at or below the MTD of PT-112 in the combination.
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A Phase I Study of Cabazitaxel, Mitoxantrone, and Prednisone (CAMP) for Patients with Metastatic Castration-Resistant Prostate Cancer and no Prior Chemotherapy
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone (CAMP) in combination at different dose levels and to determine the highest dose that does not cause bad side effects. The investigators want to find out what effects, good and/or bad, CAMP has on patients and their metastatic castration-resistant prostate cancer.
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A Phase II, Multi-center, Open-label Study of Sequential LGX818/MEK162 Combination Followed by a Rational Combination With Targeted Agents After Progression, to Overcome Resistance in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma (LOGIC-2)
Scottsdale/Phoenix, Ariz.
The primary purpose of this study is to assess the anti-tumor activity of LGX818/MEK162 in combination with targeted agents after progression on LGX818/MEK162 combination therapy, as well as the safety and tolerability of the novel triple combinations.
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A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy (VIABLE)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care Chemotherapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer.
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A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma
Scottsdale/Phoenix, Ariz.
This study is being conducted to examine survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.
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A Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of VT-464 in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone.
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The goal of this clinical study is to determine the safety and efficacy of VT-464, a lyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients with castration-resistant prostate cancer (CRPC) who have been previously treated with enzalutamide or abiraterone.
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AFT-19 A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
Scottsdale/Phoenix, Ariz.
This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
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An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to find out more about the side effects of rovalpituzumab tesirine (SC16LD6.5) and what doses of rovalpituzumab tesirine (SC16LD6.5) are safe for people with specific delta-like protein 3-expressing cancers.
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Biomarkers to Predict for and Monitor Response to PD-1/PD-L1 Inhibitors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
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.
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c17-191: A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer (CASCARA)
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to determine the proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria 1 year, with 6 cycles of carboplatin and cabazitazel followed by continued abiraterone.
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CO-338-052 TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency (TRITON2)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.
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CO-338-063 TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency (TRITON3)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib verses treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
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CO39303, A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer (IPATential150)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).
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EAY131, Molecular Analysis for Therapy Choice (MATCH)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
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Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma (Checkmate 218)
Scottsdale/Phoenix, Ariz.
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.
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I3Y-MC-JPCM(c) CYCLONE 2: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, Ariz.
The purpose of this study is to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer.
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MC1351 PROstate cancer Medically Optimized genome enhanced ThErapy (PROMOTE) (PROMOTE)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
This research trial studies gene expression in patients with metastatic prostate cancer receiving cytochrome P45017 (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.
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ML28897/PRO 02 My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.,
Jacksonville, Fla.
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
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Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
Rochester, Minn.,
Mankato, Minn.,
Scottsdale/Phoenix, Ariz.,
Eau Claire, Wis.
This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.
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RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients with COVID-19 with Camostat MesilatE, a TMPRSS2 Inhibitor (RECOVER)
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary purpose of this study is to determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
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Stand Up to Cancer Consortium Genomics-Enabled Medicine for Melanoma (G.E.M.M.): Using Molecularly-Guided Therapy for Patients With BRAF Wild-Type (BRAFwt) Metastatic Melanoma
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.
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The Circulating Cell-free Genome Atlas Study (CCGA)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
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.
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The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer
Scottsdale/Phoenix, Ariz.
The proposed clinical trial will study the effects of 12 months of therapy with ARN-509 alone, or in combination with an LHRH agonist (LHRHa), each compared to LHRHa alone, in men with a rapidly rising serum PSA after prior definitive local therapy for prostate cancer. The endpoints selected reflect measurable short term effects of androgen deprivation therapy (ADT), including quality of life and several metabolic parameters. In addition, the relative effect of each treatment strategy on PSA suppression as well as testosterone recovery (and subsequent PSA progression) after 12 months of therapy will be evaluated.
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Utility of Early Genomic Assessment in Patients with Untreated Advanced Biliary Cancers and Germ Cell Tumors
Scottsdale/Phoenix, Ariz.
The long term research goal and objective of this application is to improve the clinical outcomes of patients with biliary tract cancers and germ cell tumors. There is an imminent need to identify novel targets suitable for drug development in patients with these cancers given the need for novel therapeutics for patients diagnosed with BTCs and GCTs.
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