This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer
✓. Relapsed disease
✓. Patients with up to three prior therapies. In patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months; in addition patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines are also eligible
✓. Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression
✓. Mandatory de novo tumor biopsy (not older than 3 months) sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of PDL1 status prior to randomization for stratification.
✓. Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)
✓. Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line
Exclusion criteria
✕. Females aged ≥ 18 years at signing at time of signing informed consent form
✕0. Signed written informed consent and ability to comply with the study protocol, in the investigator's judgement
✕1. Adequate hematological, renal and hepatic function within 28 days prior to first administration of study treatment:
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What they're measuring
1
Overall Survival (OS)
Timeframe: From date of randomizationrandomization to date of death from any cause assessed up to 40 months
2
Progression-free survival
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months
2. Patients must have adequately controlled blood pressure (BP), with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study.
✕3. Estimated life expectancy of at least 3 months
✕4. ECOG performance status 0 - 1
✕5. Negative urine or serum pregnancy test within 7 days of study treatment in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1
✕6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later.