Clinical Trials Using Anti-PD-1 Monoclonal Antibody TSR-042
Clinical trials are research studies that involve people. The clinical trials on this list are studying Anti-PD-1 Monoclonal Antibody TSR-042. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors
This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg / kg) based on emerging safety and PK / PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.
Location: 23 locations
A Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare progressive survival rate of PD-L1 positive patients and also to compare progression-free survival (PFS) of all participants with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab, and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2. Approximately 1228 participants will be enrolled into the study and the duration of the study will be approximately 78 months.
Location: 15 locations
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts: with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 as a single agent (Part 1a); in combination with anti-programmed cell death protein-1 (PD-1) antibody, nivolumab (Part 1b); in combination with anti-PD-1 antibody, TSR-042 (Part 1c); in combination with TSR-042 and anti-lymphocyte-activation gene 3 (LAG-3) antibody, TSR-033 (Part 1d); in combination with TSR-042 in participants not previously treated with programmed death-ligand 1 [PD-(L)1] (Part 1e) and in combination with docetaxel (Part 1f). Part 2 of the study will evaluate the antitumor activity of TSR-022, both as monotherapy and in combination with TSR-042 in participants with pre-specified tumor types.
Location: 15 locations
A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
Endometrial cancer accounts for greater than 90 percent (%) of all uterine cancer. The majority of participants with endometrial cancer are diagnosed in early stages (Stage I or II) and receive surgery with curative intent; however, approximately 20% are diagnosed with advanced or metastatic disease (Stage III or IV) for which a surgical cure is not possible. Paclitaxel in combination with carboplatin has been shown to be efficacious against a variety of different tumor types, including non-small-cell-lung-carcinoma (NSCLC), ovarian cancer, endometrial cancer, and head and neck cancer. This study will evaluate the efficacy and safety of dostarlimab in combination with carboplatin-paclitaxel, the standard of care for participants with recurrent or primary advanced endometrial cancer. This study consists of a Screening Period, Treatment Period, an End of Treatment (EOT) Visit, a Safety Follow-up Visit, and a Survival Assessment Period. Participants will be randomized in a 1:1 ratio to receive either dostarlimab plus carboplatin paclitaxel or placebo plus carboplatin-paclitaxel.
Location: 17 locations
Dostarlimab before Chemoradiotherapy and Surgery for the Treatment of Locally Advanced Mismatch Repair Deficiency or Microsatellite Instability Rectal Cancer
This phase II trial studies how well dostarlimab (TSR-042) before standard chemoradiotherapy and surgery works in treating patients with mismatch repair deficiency or microsatellite instability rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Dostarlimab is a type of medication called an antibody, which is a protein made by the immune system to protect the body from harm. Dostarlimab blocks another protein (programmed cell death receptor-1, or PD-1) that usually acts as a “brake” on the immune system. Blocking this protein is like releasing the brakes, so that the immune system can target tumor cells and kill them.
Location: 7 locations
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)
GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab, chemotherapy or other immune therapies. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.
Location: 6 locations
Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with dostarlimab, modified folinic acid (FOL) / leucovorin, 5-fluorouracil and oxaliplatin (OX) (mFOLFOX6) or FOL / leucovorin, 5-fluorouracil and irinotecan (IRI) (FOLFIRI), and bevacizumab in participants with advanced solid tumors in a broad range of solid tumors. Participants with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with dostarlimab (Part 1c). RP2D decisions will be based on the occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), as well as pharmacodynamics (PDy) data. Part 2A of the study will investigate the anti-tumor activity of TSR-033 and dostarlimab in combination in participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC). Part 2B of the study will investigate the safety and anti-tumor activity of TSR-033 and dostarlimab in combination with chemotherapy (Cohort B1: mFOLFOX6 and Cohort B2: FOLFIRI) and bevacizumab in participants with advanced or metastatic MSS-CRC.
Location: 5 locations
Niraparib, Dostarlimab, and Radiation Therapy for the Treatment of Metastatic Pancreatic Cancer
This phase II trial investigates how well niraparib, dostarlimab, and radiation therapy work in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Niraparib is a type of drug called a “PARP inhibitor”, which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill tumor cells by not allowing the tumor cells to repair its DNA damage or prevent DNA damage from occurring. Dostarlimab is a type of antibody (a protein that attaches to other cells to fight off infection) that is believed to work by attaching to a protein called PD-1 on T cells. This PD-1 protein controls parts of the immune system (the system in the body that fights off infections and diseases) by shutting down certain immune responses responsible for recognizing and destroying tumor cells. Dostarlimab may work by inhibiting the PD-1 protein, thus allowing immune cells to recognize and destroy tumor cells. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Giving niraparib, dostarlimab, and radiation therapy may help treat patients with pancreatic cancer.
Location: 4 locations
Dostarlimab Alone or in Combination with Cobolimab for the Treatment of Resectable Stage III or IV Melanoma
This phase II trial investigates how well dostarlimab alone or in combination with cobolimab works in treating patients with stage III or stage IV melanoma that can be removed by surgery (resectable). Dostarlimab is a PD-1 inhibitor and cobolimab is a TIM-3 inhibitor. Dostarlimab works by encouraging the body’s own immune system to attack the cancer cells. The immune system is a network of cells, tissues, and organs that work together to defend the body against diseases. Cobolimab may improve upon the benefit of dostarlimab. Giving dostarlimab in combination with cobolimab may work better to treat stage III or IV melanoma compared to dostarlimab alone.
Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania
Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed / Refractory Multiple Myeloma (RRMM) (DREAMM 5)
B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I / II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed / refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.
Location: 2 locations
Niraparib and Dostarlimab for the Treatment of Recurrent or Progressive Cervical Cancer, STAR Study
This phase II trial studies how well niraparib and dostarlimab work for the treatment of cervical cancer that has come back (recurrent) or is growing, spreading, or getting worse (progressive). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may kill more tumor cells in patients with cervical cancer.
Location: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma
TSR-042 and Radiation for the Treatment of Stage I-II Endometrial Cancer
This phase I trial studies the side effects of TSR-042 and radiation in treating stage I-II endometrial cancer. Immunotherapy with TSR-042, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving TSR-042 in combination with radiation therapy may work better in treating patients with endometrial cancer compared to radiation therapy alone.
Location: Siteman Cancer Center at Washington University, Saint Louis, Missouri
Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1 / 2 and PALB2 Mutated Metastatic Pancreatic Cancer
This phase II trial studies how well niraparib and dostarlimab work in treating patients with germline or somatic BRCA1 / 2 and PALB2 mutated pancreatic cancer that has spread to other places in the body (metastatic). Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as dostarlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and dostarlimab may kill more tumor cells.
Location: Mayo Clinic in Rochester, Rochester, Minnesota
Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer
This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.
Location: 19 locations