NCT04895046

Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma

Molecularly Driven, Immune-Based, Maintenance Niraparib and Dostarlimab in Advanced Stage Cholangiocarcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Walid Shaib, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HRD
• Cholangiocarcinoma
• Metastatic Cancer

Interventions

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

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2021-05-20
• Last updated: 2022-06-29

Regulatory

• FDA-regulated drug study