Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCanadian Cancer Trials Group

About this trial

This study is being done to answer the following question: What are the effects of a new drug or drugs on ovarian cancer? The pre-study screening may be done to test a sample of tissue for biomarkers to determine participation in the study.

Eligibility criteria

Qualifiers

This study will enroll women with platinum resistant high grade serous ovarian cancer.

This study is open to minorities as appropriate but is not designed to measure differences in intervention effects.

All patients must be registered for screening prior to study enrollment, however, if biomarker testing results are not required prior to enrollment to a substudy, then enrollment can proceed immediately. CCTG will advise sites when biomarker testing results are required prior to substudy enrollment.

Patients must have platinum resistant high grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within 6 months of last platinum containing chemotherapy. Histological confirmation of the original primary tumour is required.

Disqualifiers

Patients with a history of other malignancy may be eligible if curatively treated and/or the malignancy does not affect the determination of safety or efficacy of the investigational regimen (must be confirmed with CCTG prior to enrollment).

history of intra-abdominal abscess within 3 months prior to starting treatment;

other active infection or chronic liver disease requiring systemic therapy;

active or known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection on antiviral treatment or with detectable viral load;

Trial design

Treatments tested in this trial

  • Durvalumab
  • BA3011
  • BA3021
  • ENB003
  • Toripalimab

Treatment groups

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Canadian Cancer Trials Group

Lead sponsor

Cancer Research Institute, New York City

Collaborator

AstraZeneca

Collaborator

BioAtla, Inc.

Collaborator