Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer | Drug: Durvalumab Drug: BA3011 Drug: BA3021 Drug: To be determined | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer |
Actual Study Start Date : | October 12, 2021 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2025 |
Arm | Intervention/treatment |
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Experimental: Durvalumab + BA3011 |
Drug: Durvalumab
1500mg IV, 60 min day 1 every 4 weeks
Drug: BA3011 IV
|
Experimental: Durvalumab + BA3021 |
Drug: Durvalumab
1500mg IV, 60 min day 1 every 4 weeks
Drug: BA3021 IV
|
Experimental: Sub Study X (etc.) |
Drug: To be determined
To be determined
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
All patients must have measurable disease as defined by RECIST 1.1. The criteria for defining measurable disease are as follows:
Systemic Therapy:
Other Therapy:
• Radiation, endocrine therapy, or other non-anti-cancer investigational agents are permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose and enrollment. Exceptions may be made for low-dose, non-myelosuppressive radiotherapy after consultation with CCTG.
All patients must have consented to:
Exclusion Criteria:
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:
Central nervous system metastases
Note: Seasonal vaccines for influenza are general inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.
Contact: Janet Dancey | 613-533-6430 | jdancey@ctg.queensu.ca | |
Contact: Pierre-Olivier Gaudreau | 613-533-6430 | p-ogaudreau@ctg.queensu.ca |
Canada, British Columbia | |
BCCA-Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 |
Study Chair: | Helen MacKay | Sunnybrook Health Sciences Centre, Toronto, Ontario Canada | |
Study Chair: | Anna Tinker | BCCA - Vancouver Cancer Centre, BC Canada |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 26, 2021 | ||||||||
First Posted Date ICMJE | June 8, 2021 | ||||||||
Last Update Posted Date | November 15, 2021 | ||||||||
Actual Study Start Date ICMJE | October 12, 2021 | ||||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
To efficiently identify based on objective response rate (ORR), 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 ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer | ||||||||
Official Title ICMJE | An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer | ||||||||
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. | ||||||||
Detailed Description | This study is being conducted to determine if this approach is better or worse than the standard of care for ovarian cancer. The standard of care is defined as care most people get for ovarian cancer. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2025 | ||||||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
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.
Exclusion Criteria:
Note: Seasonal vaccines for influenza are general inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04918186 | ||||||||
Other Study ID Numbers ICMJE | I240 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Canadian Cancer Trials Group | ||||||||
Study Sponsor ICMJE | Canadian Cancer Trials Group | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Canadian Cancer Trials Group | ||||||||
Verification Date | November 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |