Active, not recruiting

Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

# NCT04620954 Trial phase: 1, 2 Study type: immunotherapy, chemotherapy, targeted

Study Start Date

October, 2020

Scientific Title

A Phase I/II Clinical Trial to Evaluate Platinum-based Chemotherapy, Oregovomab and Nivolumab in Patients With Platinum Sensitive Recurrent Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

Summary

This is an open-label, single-arm, phase I/II, single-center study with dose finding and dose expansion parts. This study hypothesizes that the combination of platinum-based chemotherapy, Oregovomab and Nivolumab will improve intracellular CA 125 antigen processing and elicit a stronger systemic CA 125-specific T cell response and that it will be in a manner that is synergistic, safe and clinical efficacious in patients with relapsed platinum sensitive epithelial ovarian carcinoma (EOC).

Signed Written Informed Consent - Able to understand and voluntarily sign the Informed Consent Form (ICF). Written informed consent must be obtained before any study specific procedures that are not part of standard of care. - Willing and able to comply with scheduled visits, treatment schedule, laboratory test, and other protocol requirements - Age ≥ 21 years old Age and Target Population - Histologically and/or cytologically confirmed diagnosis of epithelial ovarian, fallopian tube and primary peritoneal carcinoma (including carcinosarcoma) - Serum CA 125 level at enrollment must be at least 5 times the upper limit of normal (ULN) using local laboratory ranges - Objective evidence of disease progression after 2 to 3 prior lines of cytotoxic chemotherapy including (neo)adjuvant platinum-based regimen for advanced stage disease. Patients may have received prior treatment with Bevacizumab and/or poly ADP ribose polymerase (PARP) inhibitor in any line, including as maintenance therapy. - Disease progression occurring at least 6 months after the last dose of platinum therapy was given following the penultimate line of chemotherapy before enrollment - Presence of: 1. measurable disease as defined by RECIST v1.1 AND a pre-treatment serum CA 125 level ≥ 5 times ULN on 1 occasion, OR 2. non-measurable but evaluable disease such as ascites and pleural effusions attributable to disease or radiologic abnormalities that do not meet RECIST v1.1 criteria AND a pre-treatment serum CA 125 level ≥ 5 times ULN on 2 occasions at least 1 week apart, OR 3. non-evaluable, non-measurable disease as defined by RECIST v1.1 AND pre- treatment CA 125 level ≥ 5 times ULN on 2 occasions at least 1 week apart - Estimated life expectancy greater than 3 months - Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1 - Adequate hematologic and end organ function, defined by the following local laboratory results obtained within 14 days before study entry: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) 2. White Blood Cell (WBC) count ≥ 2.0 × 109/L 3. Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) 4. Hemoglobin ≥ 9.0 g/dL 5. Creatinine clearance (CrCl) ≥ 30 ml/min according to Cockcroft-Gault formula 6. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5 x ULN in patients with liver metastases) 7. Serum bilirubin ≤ 1.5 x ULN (except patients with known Gilbert's disease who have serum bilirubin level ≤ 3 x ULN) - Normal Thyroid Stimulating Hormone (TSH) and free Thyroxine (fT4) levels - Recovery of acute AEs of prior anticancer therapies, including surgery and radiotherapy, to baseline or CTCAE grade ≤ 1 before study entry Reproductive Status - Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) within 24 hours before study entry - No breastfeeding - WOCBP must agree to observe abstinence from heterosexual sexual intercourse, or use contraceptive methods that results in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of Nivolumab.

Study Design

Primary purpose: Treatment , Allocation: N/A , Intervention model: Single Group Assignment , Masking: None (Open Label),

Conditions

Epithelial Ovarian Cancer

Other Study ID Numbers

NCC OV-03

Locations

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