NCT04779151

Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab

An Open Label Phase II Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatment will consist of a PARP inhibitor (niraparib) monotherapy priming period (cycle 0; 21 days); an anti-PD-1 antibody (Dostarlimab ; TSR-042) will then be added from C1D1 every 21 days in combination for the first 4 cycles, and then every 42 days. Disease will be assessed every 2 cycles (6 weeks) from C3D1 by CT-scan (or MRI or bone scan, if relevant). Patients still under treatment after 1 year may have tumor evaluation spaced out every 3 cycles

Detailed description

This study will make it possible to evaluate the efficacy and safety of use of the combination of two products: niraparib and Dostarlimab (also called TSR-042). It will assess whether these two drugs can not only stop the growth of tumor cells but also activate immune cells to kill them. Patients that tolerates these products well will also be monitored The investigating doctor suggests that patient take part in this study because his disease may benefit from the treatments administered in this study. Only patients whose tumor is likely to respond to the drugs administered, based on preclinical results or clinical data, will be able to participate in this study. Patient are selected because his tumor seems to have the characteristics that allow him to be included in one of the following three cohorts: Cohort 1: tumor has a particular mutation; this cohort will include 5 groups according to the type of cancer: bladder cancer (group 1A), cancer of the stomach or of the esophago-gastric junction (group 1B), head and neck cancer (group 1C), bile duct cancer (group 1D) or other cancers (group 1E) Cohort 2: tumor is bladder cancer and has shrunk under previous treatment with platinum salts Cohort 3: clear cell kidney cancer. These products have already been tested in combination and their combination has shown that it is possible without causing toxicity. About 120 patients will participate in the study in several centers in France. All patients will receive the combination of these two treatments.

Conditions

• Urothelial Bladder Cancer
• Gastric Adenocarcinoma
• Gastro-oesophageal Adenocarcinoma
• Head and Neck Cancer
• Biliary Tract Cancer
• Platinum-sensitive Urothelial Bladder Cancer
• Clear Cell Renal Cell Carcinoma
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Dostarlimab	Substance: immunoglobulin G4 (IgG4) humanized monoclonal antibody (mAb) that binds with high affinity to PD-1 Manufacturer: Tesaro Inc. Dose: 500 mg every 21 days for the first 4 cycles, followed by 1,000 mg every 42 days cycle (ie, Q6W)
DRUG	Niraparib	Substance: Inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) Manufacturer: Tesaro Inc. Dose: Flat-fixed dose (if \<77kg or platelets \<150,000 μL: 200mg; if \>/=77kg and platelets \>/= 150,000μL: 300mg)

Timeline

• Start date: 2021-04-07
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2021-03-03
• Last updated: 2025-12-01

Locations

1 site across 1 country: France