EUCTR2017-000202-37-DK
Active, not recruiting
Phase 1
Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer – a randomized Phase III trial
DrugsAvastin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AGO Research GmbH
- Enrollment
- 550
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer
- •2\.Relapsed disease
- •3\.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
- •4\.Measurable disease, evaluable disease in combination with GCIG CA\-125 criteria, or histologically proven relapse/progression
- •5\. 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.
- •6\.Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)
- •7\.Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line
- •8\.Patients previously treated with bevacizumab are eligible, with the exclusion of those patients that has suspended bevacizumab for more than 2 subsequent cycles or permanently discontinued bevacizumab during their previous treatment due to toxicity. A washout period of at least 20 days after last bevacizumab treatment must be adhered.
- •9\.Females aged \= 18 years at signing at time of signing informed consent form
- •10\.Signed written informed consent and ability to comply with the study protocol, in the investigator’s judgement
Exclusion Criteria
- •1\. Non\-epithelial tumor origin of the ovary, the fallopian tube or the
- •2\. Ovarian tumors of low malignant potential
- •3\. Malignancies other than ovarian cancer within 5 years prior to
- •randomisation.
- •4\. More than three prior systemic anticancer regimens; maintenance
- •therapies are not calculated as separate line
- •5\. Prior systemic anticancer therapy within 28 days before
- •randomization
- •6\. Prior radiotherapy to the pelvis or the abdomen.
- •7\. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti\-neoplastic hormonal therapy, or
Outcomes
Primary Outcomes
Not specified
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