Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
- Trial number:
- NCT04620954
- Trial phase:
- 1, 2
- Study type:
- Immunotherapy, Chemotherapy, Targeted therapy
- Overall status:
- Active, not recruiting
Study start date
Scientific title
Summary
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:
measurable disease as defined by RECIST v1.1 AND a pre-treatment serum CA 125 level ≥ 5 times ULN on 1 occasion, ORnon-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 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:
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)White Blood Cell (WBC) count ≥ 2.0 × 109/L Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Creatinine clearance (CrCl) ≥ 30 ml/min according to Cockcroft-Gault formula Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN (or ≤ 5 x ULN in patients with liver metastases) 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 entryNo 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.