Study on Niraparib and Dostarlimab Combination Therapy for Recurrent or Persistent Uterine Serous Carcinoma

Sponsor: Casey Cosgrove

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05870761

Provider View

This clinical trial is exploring the effectiveness of combining two drugs, niraparib and dostarlimab, to treat uterine serous carcinoma that has returned or is not responding to treatment. Niraparib helps stop cancer cells from growing, while dostarlimab uses the immune system to fight cancer.

Patient Parameters

Program Overview

The purpose of this phase II study is to see how well the combination of niraparib and dostarlimab works in treating uterine serous carcinoma that has come back or is persistent. Niraparib is a PARP inhibitor that stops cancer cells from growing, and dostarlimab is an immunotherapy drug that helps the immune system attack cancer cells. The study aims to find out if using these two drugs together is more effective in treating this type of cancer.

Description

The main goal of this study is to evaluate how effective the combination of niraparib and dostarlimab is in treating patients with recurrent or persistent uterine serous carcinoma. Researchers will measure the overall response rate, which includes both partial and complete responses to the treatment.

Secondary goals include estimating how long patients live without the cancer getting worse (progression-free survival) and the clinical benefit rate, which is the percentage of patients who achieve complete response, partial response, or stable disease. The study will also assess the safety and tolerability of the drug combination.

Patients will receive dostarlimab through an IV and take niraparib orally. They will also have MRI or CT scans and provide blood samples throughout the trial. After completing the study treatment, patients will have follow-up visits every six months for two years, and then annually.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or persistent uterine serous carcinoma confirmed by biopsy or surgery, and have previously received carboplatin and paclitaxel.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have tumor tissue available or be willing to provide a fresh biopsy before starting treatment.
  • Have measurable disease according to standard criteria.
  • Have had no more than three prior chemotherapy treatments, including carboplatin and paclitaxel.
  • May have had prior PD1/PDL1 inhibitor therapy if there were no severe immune-related side effects.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Be able to take oral medications.
  • Agree not to donate blood during the study and for 120 days after the last dose.
  • If of childbearing potential, have a negative pregnancy test and agree to use effective contraception during the study and for six months after the last dose.
  • Agree not to breastfeed during the study and for 120 days after the last dose.
  • Understand the study and agree to participate by providing written informed consent.
  • Have recovered from any side effects of previous treatments to a certain level.

Exclusion Criteria

  • Not be enrolled in another interventional clinical trial.
  • Not have had major surgery within three weeks before starting the study treatment.
  • Not have received investigational therapy within four weeks before starting the study treatment.
  • Not have had recent radiation therapy affecting a large portion of the bone marrow or any radiation therapy within one week before starting the study treatment.
  • Not have a known allergy to niraparib or dostarlimab.
  • Not have previously progressed on a PARP inhibitor.
  • Not have had severe immune-related side effects from prior immunotherapy.
  • Not have received a blood transfusion or colony-stimulating factors within four weeks before starting the study treatment.
  • Not have a history of certain blood disorders or uncontrolled medical conditions.
  • Not have had another type of cancer within two years before starting the study treatment, except for certain skin or cervical cancers.
  • Not have a known history of brain metastases.
  • Not have a diagnosis of immunodeficiency or be on immunosuppressive therapy within seven days before starting the study treatment.
  • Not have active hepatitis B or C, or HIV.
  • Not have an active autoimmune disease requiring treatment in the past two years.
  • Not have a history of interstitial lung disease.
  • Not have received a live vaccine within 30 days before starting the study treatment.
  • Not have a history of posterior reversible encephalopathy syndrome (PRES).

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