Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Sponsor
Walid Shaib, MD
Study ID
NCT04895046
Phase
PHASE2
Status
Withdrawn

Conditions

  • Cholangiocarcinoma
  • HRD
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    300 mg taken orally (all cycles)
  • Dostarlimab — DRUG
    500 mg (cycles 1-4) intravenously
  • Dostarlimab — DRUG
    1000 mg (cycle 5+) intravenously

Study Details

Phase II, single arm trial, evaluating molecularly selected, immune-based combination therapy in maintenance treatments for advanced cholangiocarcinoma, selecting patients on the homologous recombination deficient (HRD) signature.

Key Dates

Start date
Oct 11, 2021
Status verified
Jun 2022
Primary completion
Sep 30, 2022
Completion
Sep 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Group
    Cycle 1-4 (cycle length 4 weeks): Niraparib 300 mg taken orally on days 1-21 and Dostarlimab 500 mg intravenously on day 1 Cycle 5 and above (cycle length 3 weeks): Niraparib 300 mg taken orally on days 1-21 and 1000 mg intravenously on day 1 of every other cycle

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 4-6 months ]

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