Niraparib + Dostarlimab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Trisha Wise-Draper, MD,PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Trisha Wise-Draper

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, dostarlimab and niraparib, in patients with head and neck cancer that has come back or spread. Dostarlimab helps the immune system attack cancer, while niraparib prevents cancer cells from repairing themselves. Niraparib is an oral drug approved for maintenance treatment in ovarian, fallopian tube, or primary peritoneal cancer.

Research Team

Trisha Wise-Draper, MD,PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for adults with recurrent or metastatic non-cutaneous head and neck cancers (HNSCC) that can't be cured by surgery or radiation. Participants must be able to swallow pills, have a reasonable level of physical function (ECOG ≤2), and not have had severe side effects from previous cancer treatments, except hair loss. Those who've had both immunotherapy and PARP inhibitors, certain allergies, nasopharyngeal/salivary gland tumors, uncontrolled illnesses, or need high-dose steroids can't join.

Inclusion Criteria

My head or neck cancer has returned or spread and cannot be removed by surgery or cured with radiation.

I can take care of myself but might not be able to do heavy physical work.

You need to be able to swallow pills.

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

My cancer is in the nasopharynx or salivary glands.

I have been treated with both immunotherapy and PARP inhibitors before.

Treatment Details

Interventions

• Dostarlimab (PD-1 Inhibitor)
• Niraparib (PARP Inhibitor)

Trial Overview The study tests the effectiveness of combining two drugs: Niraparib (a pill) and Dostarlimab (an injection), in patients with advanced HNSCC. The goal is to see how well this combination works in shrinking or controlling the cancer.

Participant Groups

Group I: Niraparib & Dostarlimab Experimental Treatment 2 Interventions

Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg. Dostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.

Who Is Running the Clinical Trial?

Trisha Wise-Draper

Lead Sponsor

Trials

6

Recruited

230+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School