Study on Niraparib and Dostarlimab for Solid Tumors with HRD Gene Mutations

Sponsor: West Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04983745

Provider View

This clinical trial is testing a combination of two drugs, niraparib and dostarlimab, to see if they are safe and effective in treating patients with advanced solid tumors that have specific gene mutations known as homologous recombination deficiency (HRD).

Patient Parameters

Program Overview

This study is exploring the use of two drugs, niraparib and dostarlimab, in patients with advanced solid tumors that have specific gene mutations called homologous recombination deficiency (HRD). The trial aims to determine if this combination is safe and can help control the cancer in patients whose tumors cannot be surgically removed, have returned, or have spread to other parts of the body.

Eligibility Criteria

Inclusion Criteria

  • Have an advanced solid tumor that cannot be removed by surgery, has returned, or has spread, and has a specific HRD gene mutation such as BRCA1, BRCA2, or others listed.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function as determined by specific blood tests.
  • Agree not to donate blood during the study and for 90 days after the last dose of treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 180 days after the last dose.
  • Men must agree to use effective contraception during the study and for 180 days after the last dose.
  • HIV-positive patients can participate if they are on effective anti-retroviral therapy with a stable viral load and CD4 count.
  • Be willing to provide a tumor sample or undergo a biopsy if needed.
  • Understand the study and agree to participate by signing informed consent.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have certain types of cancer, such as prostate cancer or specific ovarian, breast, and pancreatic cancers with known BRCA mutations.
  • Have had major surgery within the last 3 weeks and not fully recovered.
  • Have received other investigational treatments recently.
  • Have had significant radiation therapy recently.
  • Have allergies to the study drugs.
  • Have received blood transfusions or certain growth factors recently.
  • Have had severe blood-related side effects from previous chemotherapy.
  • Have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Have serious, uncontrolled medical conditions or infections.
  • Have had another type of cancer diagnosed or treated within the last 2 years, except for certain skin or cervical cancers.
  • Have untreated or symptomatic brain metastases.
  • Have had severe immune-related side effects from previous immunotherapy.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have received a live vaccine recently.

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