RECRUITING

Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer

Quick Facts

Study Start:2022-05-03

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04918186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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: * 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: 1. 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). 2. 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	* 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. * 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.

Inclusion Criteria

Exclusion 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.
* 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:
* 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:
1. 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).
2. 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

* 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.
* 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

Study Contact

Janet Dancey

CONTACT

613-533-6430

jdancey@ctg.queensu.ca

Pierre-Olivier Gaudreau

CONTACT

613-533-6430

p-ogaudreau@ctg.queensu.ca

Principal Investigator

Helen MacKay

STUDY_CHAIR

Sunnybrook Health Sciences Centre, Toronto, Ontario Canada

Anna Tinker

STUDY_CHAIR

BCCA - Vancouver Cancer Centre, BC Canada

Study Locations (Sites)

The University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: Canadian Cancer Trials Group

Helen MacKay, STUDY_CHAIR, Sunnybrook Health Sciences Centre, Toronto, Ontario Canada
Anna Tinker, STUDY_CHAIR, BCCA - Vancouver Cancer Centre, BC Canada

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-03

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-05-03

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Ovarian Cancer