Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer – a randomized Phase III trial

AGO Research GmbH0 sites550 target enrollmentFebruary 15, 2021

ConditionsEfficacy 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 cancer MedDRA 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]

DrugsTECENTRIQ Avastin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Efficacy 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 cancer
Sponsor: AGO Research GmbH
Enrollment: 550
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 15, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

AGO Research GmbH

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 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