- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918186
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC)
An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Pierre-Olivier Gaudreau
- Phone Number: 613-533-6430
- Email: p-ogaudreau@ctg.queensu.ca
Study Contact Backup
- Name: Janet Dancey
- Phone Number: 613-533-6430
- Email: jdancey@ctg.queensu.ca
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1Y 5L3
- Recruiting
- BCCA - Cancer Centre for the Southern Interior
-
Contact:
- Susan Ellard
- Phone Number: 686657 250 712-3900
-
Vancouver, British Columbia, Canada, V5Z 4E6
- Recruiting
- BCCA - Vancouver Cancer Centre
-
Contact:
- Anna Tinker
- Phone Number: 2707 604 877-6000
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- University Health Network
-
Contact:
- Stephanie Lheureux
- Phone Number: 2415 416 946-4501
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Odette Cancer Centre
-
Contact:
- Helen MacKay
- Phone Number: 416 480-5145
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3E4
- Not yet recruiting
- CHUM-Centre Hospitalier de l'Universite de Montreal
-
Contact:
- Diane Provencher
- Phone Number: 514 890-8444
-
Montreal, Quebec, Canada, H3T 1E2
- Not yet recruiting
- The Jewish General Hospital
-
Contact:
- Susie K.S. Lau
- Phone Number: 3114 514 340-8222
-
-
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- The University of Chicago Medical Center
-
Contact:
- John Moroney
- Phone Number: 773-834-4732
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Durvalumab + BA3011
|
1500mg IV, 60 min day 1 every 4 weeks
IV
|
Experimental: Durvalumab + BA3021
|
1500mg IV, 60 min day 1 every 4 weeks
IV
|
Experimental: Sub Study X (etc.)
|
To be determined
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate ORR by investigator assessment using RECIST 1.1
Time Frame: 36 months
|
36 months
|
Determine progression-free survival of immunotherapy regimens (RECIST 1.1 and iRECIST)
Time Frame: 36 months
|
36 months
|
Determine overall-survival of immunotherapy regimens (RECIST 1.1 and iRECIST)
Time Frame: 36 months
|
36 months
|
Number and severity of adverse events
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Helen MacKay, Sunnybrook Health Sciences Centre, Toronto, Ontario Canada
- Study Chair: Anna Tinker, BCCA - Vancouver Cancer Centre, BC Canada
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Durvalumab
Other Study ID Numbers
- I240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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