Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

NCT04918186 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: I240
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• To efficiently identify based on objective response rate (ORR), by investigator assessment using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serous ovarian cancer for later validation in randomized trials

  36 months

Secondary Outcomes (4)

• Evaluate ORR by investigator assessment using RECIST 1.1

  36 months

• Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST)

  36 months

• Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST)

  36 months

• Number and severity of adverse events

  36 months

Study Arms (3)

Durvalumab + BA3011 (Arm Closed)

EXPERIMENTAL

Drug: Durvalumab; Drug: BA3011

Durvalumab + BA3021 (Arm Closed)

EXPERIMENTAL

Drug: Durvalumab; Drug: BA3021

ENB-003 + Toripalimab

EXPERIMENTAL

Drug: ENB003; Drug: Toripalimab

Interventions

Durvalumab DRUG

1500mg IV, 60 min day 1 every 4 weeks

Durvalumab + BA3011 (Arm Closed); Durvalumab + BA3021 (Arm Closed)

BA3011 DRUG

IV

Durvalumab + BA3011 (Arm Closed)

BA3021 DRUG

IV

Durvalumab + BA3021 (Arm Closed)

ENB003 DRUG

IV

ENB-003 + Toripalimab

Toripalimab DRUG

IV

ENB-003 + Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Additional Criteria To Be Met Prior To Sub-study Enrollment All patients must fulfill all of the following criteria to be eligible for enrollment to the study. Additional eligibility criteria and relevant timings that are specific to a substudy are listed in each substudy specific protocol.
• 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.
• All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
• Chest x-ray ≥ 20 mm
• CT scan (with slice thickness of 5 mm) ≥ 10 mm - longest diameter
• Physical exam (using calipers) ≥ 10 mm
• Lymph nodes by CT scan ≥ 15 mm - measured in short axis
• Patients must have at least one disease site amendable to pre and on-treatment biopsies and must consent to undergo these tumour biopsies.
• Prior surgery is permitted provided that a minimum of at least 28 days have elapsed between any major surgical procedure and date of enrollment, and that wound healing has occurred.
• Systemic Therapy:
• There is no limit to the number of prior regimens for platinum-sensitive disease. However, patients may not have received more than one cytotoxic chemotherapy regimen for platinum-resistant disease.
• Prior treatment with an immune checkpoint inhibitor (ICI) is permissible providing the ICI was not discontinued for severe or recurrent severe toxicity (including myocarditis, or other myocardiotoxicity, encephalitis, colitis, diarrhea, pancreatitis, hypo/hyper thyroidism, hypopituitarism, adrenal insufficiency, rash, autonomic neuropathy, myasthenia gravis, Guillain-Barre, myositis/polymyositis, hepatitis, nephritis, Type 1 diabetes, thrombocytopenia)

You may not qualify if:

• 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).
• Patients with uncontrolled or serious illnesses, or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol or substudy. This includes but is not limited to:
• 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;
• history of interstitial lung disease, non-infectious pneumonitis or severe pulmonary disease exacerbated by pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc.
• clinically significant pleural, pericardial, and/or peritoneal effusion (e.g., effusion affecting normal organ function and/or requiring percutaneous drainage or diuretic control);
• autoimmune disease requiring chronic steroid use;
• prior history of a stroke or transient ischemic attack within the last 6 months;
• history of significant cardiac disease within 6 months prior to starting treatment such as myocardial infarction, unstable angina, cardiomyopathy, congestive heart failure;
• prior allogeneic stem cell transplantation or organ transplantation.
• Central nervous system metastases
• Symptomatic uncontrolled brain metastases requiring corticosteroid treatment.
• History of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting investigational agent(s).
• Pregnant or lactating (breastfeeding) women.

Sponsors & Collaborators

• AstraZeneca: collaborator
• Canadian Cancer Trials Group: lead
• Cancer Research Institute, New York City: collaborator
• BioAtla, Inc.: collaborator

Study Sites (7)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

durvalumab; toripalimab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Helen MacKay

  Sunnybrook Health Sciences Centre, Toronto, Ontario Canada

  STUDY CHAIR

• Anna Tinker

  BCCA - Vancouver Cancer Centre, BC Canada

  STUDY CHAIR

Central Study Contacts

Janet Dancey

CONTACT

613-533-6430; jdancey@ctg.queensu.ca

Pierre-Olivier Gaudreau

CONTACT

613-533-6430; p-ogaudreau@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 8, 2021
• Study Start: May 3, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (6)