Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Conditions

• MMR-D/MSI-H Colorectal Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Niraparib — DRUG
  An anti-cancer medication that helps to repair DNA when it becomes damaged, known as a PARP inhibitor.
• Dostarlimab — DRUG
  An anti-cancer medication that is a programmed death receptor-1 -blocking monoclonal antibody.

Study Details

The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC.

Key Dates

Start date

Jan 31, 2025

Status verified

Jan 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Niraparib + Dostarlimab
  Niraparib: 300/200 mg daily (weight-based dosing\*) Dostarlimab: 500 mg Q3 weeks \*Weight-based dosing: Patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/mcL, the niraparib dose is determined to be 300 mg taken orally once daily continuously in combination with dostarlimab 500 mg every 3 weeks. Patients weighing \<77 kg (\<170 lbs) OR with a platelet count \<150,000/mcL, the niraparib dosage will be 200 mg taken orally, once daily continuously in combination with dostarlimab 500 mg every 3 weeks (Q3W)

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 12 months ]