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

Sponsor
National Cancer Centre, Singapore
Study ID
NCT04620954
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oregovomab — DRUG
    2mg of Oregovomab is administered through IV on Weeks 1, 5, 9, 17.
  • Nivolumab — DRUG
    480mg of Nivolumab is administered through IV every 4 weeks (Weeks 9, 13, 17, 21).
  • Chemotherapy — DRUG
    Pegylated liposomal doxorubicin (PLD) and carboplatin are administered every 4 weeks through IV. The starting dose of PLD and carboplatin are 30mg/m\^2 and 5 AUC (Area Under the Curve) respectively.

Study Details

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).

Key Dates

Start date
Oct 7, 2020
Status verified
Dec 2020
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention

Primary Outcome Measure

Number of incidences of adverse events (AE) [ Time Frame: From time of start of treatment to the date of disease progression or death due to any cause, up to 2 years ]

Central Contacts

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