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Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

ConditionOvarian 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Durvalumab

    Drug

    1500mg IV, 60 min day 1 every 4 weeks

  • BA3011

    Drug

    IV

  • BA3021

    Drug

    IV

  • ENB003

    Drug

    IV

  • Toripalimab

    Drug

    IV

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Durvalumab + BA3011 (Arm Closed)Experimental treatment 2 interventions
Group B: Durvalumab + BA3021 (Arm Closed)Experimental treatment 2 interventions
Group C: ENB-003 + ToripalimabExperimental treatment 2 interventions

Trial outcomes

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

Time frame
36 months

Secondary outcomes

1

Evaluate ORR by investigator assessment using RECIST 1.1

Time frame
36 months
2

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

Time frame
36 months
3

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

Time frame
36 months
4

Number and severity of adverse events

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Cancer Research Institute, New York City

Collaborator

AstraZeneca

Collaborator

BioAtla, Inc.

Collaborator

Source ClinicalTrials.gov
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