Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or… (NCT03100006) | Clinical Trial Compass
TerminatedPhase 1/2
Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
Stopped: The study had poor efficacy.
Singapore13 participantsStarted 2017-02-22
Plain-language summary
The purpose of this study is to characterize the safety and tolerability, identify a recommended dose for expansion (RDE) / recommended phase II dose (RP2D), pharmacodynamics, and antitumor activity of Oregovomab vaccination in combination with Nivolumab as a novel combinatorial immunotherapeutic strategy in in female patients with recurrent epithelial ovarian cancer (EOC) who progressed after two or more prior lines of cytotoxic chemotherapy.
Who can participate
Age range21 Years – 99 Years
SexFEMALE
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Inclusion criteria
✓. Signed Written Informed Consent
✓. Age and Target Population
✓. 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 Cells (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 (Patients may be transfused or receive erythropoietic treatment to meet this criterion)
✓. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 30 ml/min according to Cockcroft-Gault formula below:
✓. AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in patients with liver metastases)
Exclusion criteria
✕. Cancer-specific Exclusions
What they're measuring
1
Number of incidences and severity of Adverse Events (AE) and Serious AEs that are treatment-related, graded based on the CTCAE v4.03
Timeframe: 4 weeks from the start of treatment
2
Overall response rate (ORR) as per Gynecological Cancer Intergroup (GCIG) criteria
Timeframe: Time from date of start of treatment until best overall response of CR or PR, up to 3 years
3
Progression-free survival (PFS) as per GCIG criteria
Timeframe: Time from date of start of treatment to the date of the first documented progression or death due to any cause, up to 3 years