Niraparib + Dostarlimab for Colorectal Cancer

Overseen By Debra Diecks, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ibrahim Halil Sahin

Must not be taking: Oxaliplatin, PARPi, others

Disqualifiers: Autoimmune, Brain metastasis, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ibrahim H. Sahin

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

This trial is for patients with a specific type of colorectal cancer that has high microsatellite instability (MSI-H) or matches Lynch syndrome criteria. It's aimed at those whose cancer progressed despite anti-PD1 therapy and are looking for new treatment options.

Inclusion Criteria

I am a man and will use contraception and not donate sperm.

I can care for myself and am up and about more than 50% of my waking hours.

Women of childbearing potential must use highly effective contraception

Exclusion Criteria

Active autoimmune disease requiring immune suppression

Participation in a treatment study of an investigational agent within 4 weeks

Presence of hepatitis B surface antigen or positive hepatitis C virus antibody test result

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive niraparib and dostarlimab for MSI-H colorectal cancer

12 months

Dostarlimab administered every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Dostarlimab
• Niraparib

Trial Overview The study is testing the combination of two drugs, Niraparib and Dostarlimab, to see if they work better together in treating MSI-H colorectal cancers. The goal is to find an effective second-line therapy for these patients.

Participant Groups

Group I: Niraparib + Dostarlimab Experimental Treatment 2 Interventions

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)

Dostarlimab is already approved in European Union, United States for the following indications:

Approved in European Union as Jemperli for:

• Mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
• dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen

Approved in United States as Jemperli for:

• Adults with dMMR recurrent or advanced solid tumors who have progressed on or following prior treatment and lack satisfactory alternative treatment options
• Primary advanced or recurrent dMMR endometrial cancer in combination with carboplatin and paclitaxel

Who Is Running the Clinical Trial?

Ibrahim Halil Sahin

Lead Sponsor

Trials

2

Recruited

150+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

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GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School