Niraparib + Dostarlimab for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen byCasey Cosgrove, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Casey Cosgrove

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial tests how well niraparib and dostarlimab work in treating patients with uterine serous carcinoma that has come back (after a period of improvement) (recurrent) and remains despite treatment (persistent). Niraparib belongs to a class of drugs called PARP inhibitors that prevent cancer cells from growing. Dostarlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Dostarlimab belongs to a class of drugs called PD-1 inhibitors that uses the patient's own immune system to treat cancer (immuno-therapy). Giving niraparib and dostarlimab may work better in treating patients with uterine serous carcinoma.

Eligibility Criteria

This trial is for adults with recurrent or persistent uterine serous carcinoma who've had carboplatin/paclitaxel treatment. They should have an ECOG status of <=1, measurable disease by RECIST, and no more than three prior chemo regimens. Prior immunotherapy is allowed if there was no progression/toxicity leading to discontinuation. Participants must not be in other trials, haven't had major surgery within 3 weeks, and recovered from previous treatments' effects.

Inclusion Criteria

Absolute neutrophil count >= 1,500/uL

Patient must have measurable disease by RECIST

My blood clotting time is normal or managed with medication.

+23 more

Exclusion Criteria

I have had PRES in the past.

Participant must not have a known hypersensitivity to niraparib and dostarlimab components or excipients

I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.

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Participant Groups

The phase II trial tests niraparib (a PARP inhibitor that stops cancer cells from growing) combined with dostarlimab (a PD-1 inhibitor immuno-therapy). The study aims to see if this combination works better for treating patients with uterine serous carcinoma compared to current standard treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment (dostarlimab, niraparib)Experimental Treatment5 Interventions

Patients receive dostarlimab IV and niraparib PO on study. Patients also undergo MRI/CT and collection of blood samples throughout the trial.

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