Comparing 3 approaches for ovarian cancer

Inclusion

• +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)
• +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → prior to study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, however, if biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → 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 criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → and relevant timings that are specific to a substudy are listed in each substudy specific protocolProtocolThe detailed plan a study must follow.Read more →.
• +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 siteTrial siteA hospital or clinic where a study is actually run.Read more → amendable to pre and on-treatment biopsies and must consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to undergo these tumour biopsies.
• +Systemic Therapy:
• +Patients may have received non-cytotoxic therapies (excluding agents targeted by the planned substudy). Refer to each substudy protocol for exclusions.
• +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:
• +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 controlControl groupThe group a new treatment is measured against.Read more →
• +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 upFollow-upContinued check-ins after the treatment part is finished.Read more →. 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 eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, 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.
• +ECOG performance status 0 or 1 and have a life expectancy ≥ 3 months.
• +Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation
• +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.
• +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.
• +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.
• +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.