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About
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.
Full description
The purpose of this Phase 2 study is to compare two doses of ONC-392 in combination with a fixed dose of pembrolizumab in participants with ovarian cancer who are resistant to platinum-based chemotherapy and have disease progression on line of therapy containing bevacizumab. Results from this study will be used to inform the study design, patient population, and dose selection for future studies in advanced ovarian cancer.
Enrollment
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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:
The time is calculated from the date of last administrated dose of platinum therapy to the date of radiographic imaging with disease progression.
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:
At least 1 measurable target lesion according to RECIST 1.1, including the following criteria:
ECOG score 0 or 1.
Time from prior therapy:
In the opinion of the investigator, the patient must have a life expectancy of at least 12 weeks and is well enough to receive experimental therapy.
Adequate organ function as determined by laboratory tests as defined below at screening.
System Laboratory Value Hematological Absolutely neutrophil count (ANC) ≥1500/µL Platelets ≥100,000/µL Hemoglobin1 ≥9.0 g/dL or 5.6 mmol/L Renal Creatinine clearance as calculated per Cockcroft-Gault or MDRD formula > 30 mL/min Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
AST, ATL ≤3 × ULN (≤5 × ULN for participants with liver metastases) Serum Albumin ≥ 2.5 g/dL
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
58 participants in 2 patient groups
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Central trial contact
Joan Durbin, MD, PhD; Pan Zheng, MD, PhD
Data sourced from clinicaltrials.gov
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