Study on Niraparib and Dostarlimab for Patients with Recurrent or Progressive Cervical Cancer

Sponsor: University of Oklahoma

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04068753

Provider View

This clinical trial is testing the safety and effects of combining two drugs, Niraparib and Dostarlimab, to treat patients with cervical cancer that has returned or is getting worse.

Patient Parameters

Program Overview

The aim of this study is to see if the combination of Niraparib and Dostarlimab is safe and how it affects patients with cervical cancer that has come back or is progressing. Participants will take Niraparib daily and receive Dostarlimab through a vein every three weeks for four cycles, then every six weeks. The treatment will continue as long as the cancer is not growing or spreading and there are no severe side effects. Patients will be monitored with tests and exams during and after treatment for up to five years.

Description

Participants in this study will first undergo tests and exams to determine if they are eligible. If eligible, they will receive Niraparib daily and Dostarlimab through a vein every three weeks for four cycles, then every six weeks. The treatment will continue as long as the cancer is not growing or spreading and there are no severe side effects. Throughout the treatment, participants will be monitored with regular tests and exams. After completing the treatment, they will continue to be monitored for up to five years to track their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Female, at least 18 years old.
  • Diagnosed with cervical cancer that has returned or is progressing.
  • Must have tumor tissue available for testing, but this does not affect eligibility.
  • Must have measurable cancer lesions.
  • Must be in good overall health with a performance status of 0 to 1.
  • Must have received at least one prior systemic treatment for cancer.
  • Must have adequate organ function.
  • Must be able to take oral medications.
  • Must agree not to donate blood during the study and for 90 days after the last treatment.
  • If able to become pregnant, must have a negative pregnancy test and agree to use birth control during the study and for 180 days after the last treatment.

Exclusion Criteria

  • Active cancer spread to the brain or spinal cord, unless treated and stable.
  • Another active cancer requiring treatment in the last 2 years, except certain skin cancers.
  • Poor medical condition that interferes with study participation.
  • Recent blood transfusion or use of certain growth factors.
  • Severe blood disorders from previous chemotherapy.
  • History of certain blood or bone marrow disorders.
  • Serious uncontrolled medical conditions or infections.
  • Pregnant or breastfeeding.
  • Immune system disorders or recent use of immunosuppressive therapy.
  • History of HIV, hepatitis B, or hepatitis C.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Not recovered from side effects of previous cancer treatments.
  • Participation in another clinical trial recently.
  • Recent major surgery or live vaccine.
  • Previous treatment with a PARP inhibitor.
  • Allergic reactions to study drugs.
  • Severe side effects from previous immunotherapy.
  • History of lung disease.

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