Description:
This is a randomized phase II study, aimed at evaluating the efficacy (through progression
free survival at 6 months) and safety of 5 different treatments involving atezolizumab,
bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian
cancer patients in order to select the optimal treatments for further development in Phase
III.
Title
- Brief Title: Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer
- Official Title: A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
EORTC-1508
- SECONDARY ID:
2015-004601-17
- NCT ID:
NCT02659384
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Bevacizumab | Avastin | Bevacizumab |
atezolizumab | | atezolizumab + bevacizumab + acetylsalicylic acid |
acetylsalicylic acid | | atezolizumab + bevacizumab + acetylsalicylic acid |
placebo | | atezolizumab + bevacizumab + placebo |
Purpose
This is a randomized phase II study, aimed at evaluating the efficacy (through progression
free survival at 6 months) and safety of 5 different treatments involving atezolizumab,
bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian
cancer patients in order to select the optimal treatments for further development in Phase
III.
Trial Arms
Name | Type | Description | Interventions |
---|
Bevacizumab | Experimental | Bevacizumab monotherapy treatment in arm 1 will be discontinued upon RECIST documented progression or upon treatment withdrawal, whichever occurs first. Patients will cross-over to the combination of bevacizumab and atezolizumab upon progression as long as they meet cross-over criteria. | |
atezolizumab + bevacizumab + placebo | Experimental | The randomized treatment regimen (atezolizumab + bevacizumab + placebo) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. | - Bevacizumab
- atezolizumab
- placebo
|
atezolizumab + bevacizumab + acetylsalicylic acid | Experimental | The randomized treatment regimen (atezolizumab + bevacizumab + acetylsalicylic acid) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. | - Bevacizumab
- atezolizumab
- acetylsalicylic acid
|
Eligibility Criteria
Inclusion Criteria:
Recurrent, histologically proven, platinum-resistant, epithelial ovarian, fallopian tube
and primary peritoneal cancer in advanced or metastatic stage. Histological diagnosis by
image guided biopsy, laparoscopy or laparotomy. Tumors diagnosed on cytology only and
borderline tumors are excluded.
At least one lesion accessible to biopsy without putting patient at risk
WHO PS: 0-2 for patients having received no more than two previous lines of therapy. WHO
PS: 0-1 for patients having received >2 previous lines of therapy
Prior chemotherapy or bevacizumab:
Any number of platinum-based chemotherapy lines are allowed but a maximum of 2 previous
non-platinum containing lines
Prior treatment with bevacizumab or other targeted agents against Vascular Endothelial
Growth Factor (VEGF) or VEGF receptor is allowed, but at least 18 weeks must have elapsed
since their last administration
Eligible patients with ≤ 2 previous treatment lines must have been previously exposed to
bevacizumab or other targeted agents against VEGF or VEGF receptor
Patients may have had prior therapy providing the following conditions are met:
Radiation therapy: wash-out period of 14 days prior to the first study treatment;
exception: single fraction radiotherapy with the indication of pain control
Systemic anti-tumor therapy: wash-out period of 21 days prior to the first study treatment
Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer
Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) except fatigue
or alopecia.
Exclusion criteria:
Age <18 years
Life expectancy of < 12 weeks
No adequate hematologic and end organ function
Use of acetylsalicylic acid, NSAIDs or other COX-2 inhibitors that cannot be stopped at
baseline and for the whole duration of the study.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Progression Free Survival at 6 months assessed by local investigator |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | European Organisation for Research and Treatment of Cancer - EORTC |
Last Updated
July 31, 2020