EUCTR2017-000202-37-ES
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AGO Research GmbH
- Enrollment
- 664
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
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\.Patient agrees and is able to provide a recent tumor biopsy (not older than 3 months) or agrees and has a tumor lesion amenable for taking a new tumor biopsy.
- •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 peritoneum
- •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 ther\-apy or anti\-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period.
- •8\.Prior treatment with anti\-CD137 or immune checkpoint blockade therapies, anti\-PD1, or anti\-PD\-L1 therapeutic antibodies or anti\-CTLA 4
- •9\.Prior randomization in AGO\-OVAR 2\.29\.
- •10\.Treatment with systemic immunostimulatory agents (including but not limited to inter\-feron\-alpha and interleukin\-2 within 4 weeks or five half\-lives of the drug (whichever is longer) prior to Cycle 1, Day 1
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEfficacy of atezolizumab in combination with non-platinum based chemotherapy and bevacizumab versus the combination of a non-platinum based chemotherapy and bevacizumab in recurrent ovarian cancerMedDRA version: 27.0Level: PTClassification code 10016182Term: Fallopian tube cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 27.0Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-000202-37-LTAGO Research GmbH550
Active, not recruiting
Phase 1
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEUCTR2017-000202-37-NOAGO Research GmbH664
Active, not recruiting
Phase 1
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEUCTR2017-000202-37-DKAGO Research GmbH550
Active, not recruiting
Phase 1
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEfficacy of atezolizumab in combination with non-platinum based chemotherapy and bevacizumab versus the combination of a non-platinum based chemotherapy and bevacizumab in recurrent ovarian cancerMedDRA version: 21.0Level: PTClassification code 10016182Term: Fallopian tube cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-000202-37-SEAGO Research GmbH664
Active, not recruiting
Phase 1
Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancerEfficacy of atezolizumab in combination with non-platinum based chemotherapy and bevacizumab versus the combination of a non-platinum based chemotherapy and bevacizumab in recurrent ovarian cancerMedDRA version: 21.0Level: PTClassification code 10016182Term: Fallopian tube cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2017-000202-37-EEAGO Research GmbH550