The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04918186
Recruitment Status : **RECRUITING NOW**
First Posted : June 8, 2021
Last Update Posted : May 9, 2023
Sponsor:
Canadian Cancer Trials Group
Collaborators:
Cancer Research Institute, New York City
AstraZeneca
BioAtla, Inc.
Information provided by (Responsible Party):
Canadian Cancer Trials Group
Study Description
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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.
Condition or disease
Intervention/treatment
Phase
Ovarian Cancer
Drug: Durvalumab Drug: BA3011 Drug: BA3021 Drug: To be determined
Phase 2
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 Design
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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
Resource links provided by the National Library of Medicine
Arms and Interventions
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Arm
Intervention/treatment
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
Outcome Measures
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Primary Outcome Measures :
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 Outcome Measures :
Evaluate ORR by investigator assessment using RECIST 1.1 [ Time Frame: 36 months ]
Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST) [ Time Frame: 36 months ]
Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST) [ Time Frame: 36 months ]
Number and severity of adverse events [ Time Frame: 36 months ]
Eligibility Criteria
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Information from the National Library of Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Female
Gender Based Eligibility:
Yes
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
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.
Patients may have received non-cytotoxic therapies (excluding agents targeted by the planned substudy). Refer to each substudy protocol for exclusions.
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)
A minimum of 4 weeks must have elapsed between last dose of prior therapy and enrollment.
All reversible prior toxicity must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity)
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.
ECOG performance status 0 or 1 and have a life expectancy ≥ 3 months.
Patients must be ≥ 18 years of age.
All patients must have consented to:
Release of tumour block from their primary or metastatic tumour, if available. If archival tissue is unavailable, a tumour biopsy is required during screening. The centre/pathologist must have agreed to the submission of the specimen(s).
Pre and on treatment tumour biopsies:
Core needle (a minimum of 6 core samples are required) or excisional biopsies or resected tissue specimens are required.
CCTG will advise sites when biomarker testing results are required prior to enrollment
Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the trial.
Patients must have adequate organ and marrow function measured within 7 days prior to enrollment including;
Absolute neutrophils ≥ 1.5 x 10^9/L (1500/µL)
Platelets ≥ 100 x 10^9/L (100 x 103/µL)
Hemoglobin ≥90g/L* (10.0 g/dL) with no blood transfusions in the past 28 days.
Bilirubin ≤ 1.5 x ULN (upper limit of normal)**
AST & ALT ≤ 2.5 x ULN; if patient has liver metastases ≤ 5.0 x ULN
Serum creatinine or: Creatinine clearance ≤ 1.5 x ULN / >50 mL/min
Albumin >35 g/L (3.5 g/dL)
INR/PTT INR < 1.7 or PTT < 4 seconds above control
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour’s driving distance) placed on patients being considered for this trial.
Patient must agree to return to their primary care facility for any adverse events, response assessments and follow-up, which may occur through the course of the trial.
In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment.
Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation
Exclusion Criteria:
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.
Patients receiving concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents.
Active or prior documented autoimmune or inflammatory disorders, including: inflammatory bowel disease (e.g. colitis or Crohn’s disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment.
Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune conditions only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions considered to be of low risk for recurrence are permitted to enroll.
Patients must not have been administered a live vaccine ≤ 4 weeks before enrollment.
Note: Seasonal vaccines for influenza are general inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and not allowed.
QTc (using the Fridericia correction calculation) >470 msec or >450 msec if history of additional risk factors for Torsade de Pointe (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval.
Contacts and Locations
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04918186
Contacts
Locations
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United States, Illinois
The University of Chicago Medical Center
**RECRUITING NOW**
Chicago, Illinois, United States, 60637
Contact: John Moroney 773-834-4732
Canada, British Columbia
BCCA – Cancer Centre for the Southern Interior
**RECRUITING NOW**
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard 250 712-3900 ext 686657
BCCA – Vancouver Cancer Centre
**RECRUITING NOW**
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Anna Tinker 604 877-6000 ext 2707
Canada, Ontario
Kingston Health Sciences Centre
Not yet **RECRUITING NOW**
Kingston, Ontario, Canada, K7L 2V7
Contact: Josee-Lyne Ethier 613 549-6666 ext 4502
Odette Cancer Centre
**RECRUITING NOW**
Toronto, Ontario, Canada, M4N 3M5
Contact: Helen MacKay 416 480-5145
University Health Network
**RECRUITING NOW**
Toronto, Ontario, Canada, M5G 2M9
Contact: Stephanie Lheureux 416 946-4501 ext 2415
Sponsors and Collaborators
Canadian Cancer Trials Group
Cancer Research Institute, New York City
AstraZeneca
BioAtla, Inc.
Investigators
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Study Chair:
Helen MacKay
Sunnybrook Health Sciences Centre, Toronto, Ontario Canada
Study Chair:
Anna Tinker
BCCA – Vancouver Cancer Centre, BC Canada
More Information
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Responsible Party:
Canadian Cancer Trials Group
ClinicalTrials.gov Identifier:
NCT04918186
Other Study ID Numbers:
I240
First Posted:
June 8, 2021 Key Record Dates
Last Update Posted:
May 9, 2023
Last Verified:
April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
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Ovarian NeoplasmsCarcinoma, Ovarian EpithelialEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Neoplasms, FemaleUrogenital Neoplasms
Endocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDurvalumabAntineoplastic Agents, ImmunologicalAntineoplastic Agents
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
