UnknownPhase 1/2

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

Singapore31 participantsStarted 2020-10-07

Plain-language 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).

Who can participate

Age range21 Years

SexFEMALE

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Inclusion criteria

✓. measurable disease as defined by RECIST v1.1 AND a pre-treatment serum CA 125 level ≥ 5 times ULN on 1 occasion, OR
✓. 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
✓. 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
✓. 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

Exclusion criteria

✕. Systemic corticosteroids at physiologic doses to treat adrenocortical insufficiency not to exceed 10 mg/day of prednisolone or equivalent
✕. Steroids as premedication for hypersensitivity reactions (e.g. premedication for Carboplatin, PLD or CT contrast medium)
✕. Intranasal, inhaled, ophthalmic topical glucocorticoids, local (e.g. intra-articular) steroid injections, and systemic mineralocorticoids (e.g. fludrocortisone)

What they're measuring

Number of incidences of adverse events (AE)

Timeframe: From time of start of treatment to the date of disease progression or death due to any cause, up to 2 years

Proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR)

Timeframe: From time of start of treatment to CR or PR, up to 2 years

Trial details

NCT IDNCT04620954

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07

Contact for this trial

Jack Chan, MD

6436 8000 jack.chan.j.j@singhealth.com.sg

View on ClinicalTrials.gov More Epithelial Ovarian Cancer trials