A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Completed · Phase 2

Conditions studied: Ovarian Neoplasms

In brief

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer.

Key facts

Study ID

NCT03574779

Run by

Tesaro, Inc.

People needed

77

Starts

2018-11-15

Expected to finish

2025-03-31

Last updated by the study team

2025-07-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Participant has not recovered (i.e., to Grade <=1 or to Baseline) from prior chemotherapy-induced adverse events (AEs).
• Participant has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy exceeding an equivalent of prednisone 10 mg daily or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
• Participant is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment.
• Participant has received prior systemic anticancer therapy including cytotoxic chemotherapy, PARP inhibitor, immune checkpoint inhibitors, hormonal therapy given with the intention to treat cancer, or biological therapy within 3 weeks of the first dose of study treatment. This washout period is required to ensure prior therapy is not confounding the toxicity profile of the investigational study drug or study drug combinations in cohorts.
• Participant has received live vaccine within 14 days of planned start of study therapy.
• Participant has symptomatic uncontrolled brain or leptomeningeal metastases. Participant who has untreated brain metastases and who is not symptomatic may enroll if the Investigator feels that treatment of these metastases is not indicated. A scan to confirm the absence of brain metastases is not required. Participant with spinal cord compression may be considered if she has received definitive treatment for this and evidence of clinically stable disease (SD) for 28 days prior to the first dose of study treatment.
• Participant had major surgery within 4 weeks of starting the study or participant has not recovered from any effects of any major surgery.
• Participant has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation of ORR by RECIST v1.1 criteria. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cancer that is considered to be low risk for progression by the investigator.
• Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. These include, but are not limited to, Coronavirus disease 2019 (COVID-19), significant cardiovascular disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, and any psychiatric disorder that prohibits obtaining informed consent.
• Participant has a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the study, might interfere with the participant's participation for the full duration of the study treatment, or is not in the best interest of the participant to participate.
• Participant has known active hepatitis B (hepatitis B surface antigen reactive) or hepatitis C (hepatitis C virus ribonucleic acid [qualitative] is detected).
• Cohort A-specific Exclusion Criteria:
• Participant has known hypersensitivity to TSR-042, bevacizumab, niraparib, their components, or their excipients.
• Participant has a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Participant has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• Participant received prior treatment with an anti-PD-1 or anti-PD-L1 agent.
• Participant has received prior treatment with anti-angiogenic therapy with the exception of bevacizumab. (Participants who received prior bevacizumab are eligible only if they did not discontinue bevacizumab due to toxicity, as established by the Investigator).
• Participant has bowel obstruction, had bowel obstruction within the past 3 months, or is otherwise judged by the Investigator to be at high risk for bowel obstruction related to the underlying disease. Participant has any history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or significant bowel involvement on computed tomography scan.
• Participant has proteinuria as demonstrated by urine protein:creatinine ratio >=1.0 at screening or urine dipstick for proteinuria >=2 (Participants discovered to have >=2 proteinuria on dipstick at Baseline should undergo 24-hour urine collection and must demonstrate <2 gram of protein in 24 hours to be eligible).
• Participant is at increased bleeding risk due to concurrent conditions (e.g., major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
• Participant has a history of recent major thromboembolic event defined as follows: Pulmonary embolism diagnosed within 3 months of enrollment; and Lower extremity deep venous thrombosis diagnosed within 3 months of enrollment.
• Exclusion criteria specific to Cohort C:
• Participant has low-grade or Grade 1 epithelial ovarian cancer (OC) or mucinous, germ cell, transitional cell, carcinosarcoma, or undifferentiated tumor.
• Participant has contraindications to surgery.
• Participant has a bowel obstruction by clinical symptoms or computed tomography (CT) scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Ventura, California, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Scarborough, Maine, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Rochester, Minnesota, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Sioux Falls, South Dakota, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Ottawa, Ontario, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — Montreal, Quebec, Canada
• GSK Investigational Site — A Coruña, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain

Full record on ClinicalTrials.gov

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