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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05751629

NCT05751629
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • Your ovarian cancer got worse within 6 months of finishing at least 4 cycles of a platinum-based chemotherapy treatment (note: if your cancer progressed during or within 4 weeks of completing your very first platinum-based treatment, you would not qualify).
  • You have never been treated with a type of drug called a PARP inhibitor for ovarian cancer.
  • You have had 1 or 2 previous treatment courses (lines of therapy) for ovarian cancer.
  • You are able to swallow and take medication by mouth.

Who may not be able to join:

  • You have had a serious allergic reaction to any of the study drugs (TSR-042, bevacizumab, or niraparib) or their ingredients.
  • You have a history of certain blood/bone marrow conditions called myelodysplastic syndrome or acute myeloid leukemia.
  • You have an active autoimmune disease (where your immune system attacks your own body) that has needed medical treatment in the last 2 years — simple hormone replacement therapies (like thyroid or insulin) do not count as this type of treatment.
  • You have previously been treated with certain immunotherapy drugs that target PD-1 or PD-L1 (a type of cancer immune treatment).
  • You have previously received anti-angiogenic therapy (drugs that block blood vessel growth in tumors), unless it was bevacizumab and you stopped it for reasons other than side effects.
  • You currently have a bowel blockage, had one in the last 3 months, or your doctor considers you at high risk for one; or you have a history of abdominal fistula, a hole in your gut, or an abdominal abscess; or imaging or examination shows significant bowel involvement.
  • You have too much protein in your urine, as measured by certain urine tests at the start of the study (confirm specific levels with trial site).
  • You are at higher risk of bleeding due to a major injury or surgery in the last 28 days, or you have had a stroke, mini-stroke, brain bleed, or significant bleeding episode in the last 3 months.
  • You have been diagnosed with a blood clot in the lung (pulmonary embolism) or a deep vein blood clot in the leg within the last 3 months — though if you have a history of blood clots and have been on stable blood-thinning medication for more than 3 months, you may still be eligible (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Tesaro, Inc.
Registry
clinicaltrials_gov
Start date
15 November 2018
Est. completion
1 April 2022

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Confirmed Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov