A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Rucaparib: Oral rucaparib will be administered twice daily

Nivolumab: IV nivolumab will be administered once every 4 weeks

Placebo Oral Tablet: Placebo tablets will be administered twice daily

Placebo IV Infusion: IV placebo will be administered once every 4 weeks

Study summary

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Eligibility

Primary outcome measure(s)

• Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) — From randomization until disease progression (up to the primary data analysis at approximately 39 months)
  PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
• Monotherapy Arm B and Arm D: Investigator Assessed PFS — From randomization until disease progression (up to the primary data analysis at approximately 39 months)
  PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
• Combination Therapy Arm A and Arm B: Investigator Assessed PFS — From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)
  PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Trial sites (238)

+ 198 more sites — see the full list on the official registry below.

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