Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (NCT04779151) | Clinical Trial Compass
TerminatedPhase 2
Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab
Stopped: Abandon of the partner, GSK
France51 participantsStarted 2021-04-07
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓.1 - Cohorts 1 A-E: DNA repair deficiency, defined as bi-allelic loss-of-function alteration (mutation and/or deletion) in at least one of the following genes: ARID1A, ARID2, ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, IDH1, IDH2, NBN, PALB2, PBRM1, RAD51C, RAD51D, FANCA, NBN, RAD51, RAD54L, SMARCA4.
✓.1.1 - Cohort 1A: Urothelial Bladder Cancer
✓.1.2- Cohort 1B: Gastric or gastro-esophageal junction adenocarcinoma
✓.1.3- Cohort 1C: Head and Neck Cancer
✓.1.4- Cohort 1D: Biliary Tract Cancer and pancreatic ductal adenocarcinoma (PDAC)
✓.1.5- Cohort 1E Others
Exclusion criteria
✕. Participation in another clinical study with an investigational product simultaneously and/or during the last 4 weeks (excepting observational or non-interventional clinical studies).
✕. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug, or five half lives of the previous agent, whichever is the shorter.
✕. Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks prior to Cycle 0 Day 1; or any radiation therapy within 1 week prior to Cycle 0 Day 1.
✕. History of another primary malignancy within 5 years prior to Cycle 0 Day 1 except for:
✕. Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents) within 2 weeks prior to Cycle 0 Day 1, or anticipated requirements for systemic immunosuppressive medications during the trial:
✕. Acute toxicities from previous therapies that have not resolved to Grade ≤ 1, with the exception of alopecia.
✕. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \> Grade 1.
✕. Participant must not have received a platelet transfusion ≤ 4 weeks prior to Cycle 0 Day 1.