ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer (NCT05446298) | Clinical Trial Compass
Active — Not RecruitingPhase 2
ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer
United States58 participantsStarted 2022-12-22
Plain-language summary
This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Age ≥ 18 yrs old female patients who provide written informed consent for the study.
✓. Patients must have a confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
✓. Patients must have received prior standard of care of surgical intervention, including hysterectomy and salpingo-oophorectomy.
✓. Patients must have platinum-resistant disease:
✓. Patients who have only 1 line of systemic therapy must have completed a minimum of four cycles of platinum-based therapy with CR or PR and then progressed between 3 to 6 months after the last dose of platinum.
✓. Patients who have received 2 or more lines of platinum therapy must have progressed ≤ 6 months (183 days) after the last dose of platinum.
✓. Patients must have received 1 or more prior systemic lines of anti-cancer therapy with or without bevacizumab or a PARP inhibitor, and for whom single-agent therapy is appropriate as the next line of treatment:
✓. Adjuvant ± neoadjuvant is considered 1 line of therapy
Exclusion criteria
✕. Patients with carcinosarcoma (malignant mixed Mullerian tumor), clear cell carcinoma, endometrioid, low grade serous, clear cell, and mucinous adenocarcinoma, and ovarian cancer not otherwise specified.
✕. Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR), or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 24 months
2
Treatment Related Adverse Events (TRAEs) and Immune Related Adverse Events (irAEs)
✕. Patients who are at high risk for disease progression including those who have ascites requiring a paracentesis within 14 days before first treatment.
✕. Patients with active symptomatic CNS metastases, unless they have received local therapy (e.g., whole brain radiation therapy \[WBRT\], surgery or radiosurgery) 21 days before study treatment and have discontinued the use of corticosteroids for this indication for a minimum of 7 days prior to study treatment.
✕. Patients who are on chronic systemic steroid therapy for autoimmune conditions or as immunosuppression at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
✕. Active second malignancy with anti-cancer treatments (except for treated in-situ carcinomas \[e.g., breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin) within the past 24 months. HIV patient with Karposi sarcoma or Castleman disease will be excluded. Patient with renal cell carcinoma will be excluded.
✕. Prior history of symptomatic pulmonary embolism or significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability.
✕. Active infection requiring systemic IV antibiotics or hospitalization within 14 days prior to administration of study drugs. Regular treatment of urinary tract infection (UTI) and/or topical treatment are allowed.