Clinical Trials /

Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer

NCT02659384

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Ovarian Neoplasms

Interventions

DrugSynonymsArms
BevacizumabAvastinBevacizumab
atezolizumabatezolizumab + bevacizumab + placebo
acetylsalicylic acidatezolizumab + bevacizumab + acetylsalicylic acid
placeboatezolizumab + 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

NameTypeDescriptionInterventions
BevacizumabExperimentalBevacizumab 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.
  • Bevacizumab
atezolizumab + bevacizumab + placeboExperimentalThe 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 acidExperimentalThe 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:Recruiting
Lead Sponsor:European Organisation for Research and Treatment of Cancer - EORTC

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