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

NCT04620954 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-12-01

No results posted yet for this study

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).

Conditions

  • Epithelial Ovarian Cancer

Interventions

DRUG

Oregovomab

2mg of Oregovomab is administered through IV on Weeks 1, 5, 9, 17.

DRUG

Nivolumab

480mg of Nivolumab is administered through IV every 4 weeks (Weeks 9, 13, 17, 21).

DRUG

Chemotherapy

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.

Sponsors & Collaborators

  • CanariaBio Inc.

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Jack Chan, MD · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620954 on ClinicalTrials.gov