Trials / Unknown
UnknownNCT04620954
Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
A Phase I/II Clinical Trial to Evaluate Platinum-based Chemotherapy, Oregovomab and Nivolumab in Patients With Platinum Sensitive Recurrent Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- National Cancer Centre, Singapore · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-10-07
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
- First posted
- 2020-11-09
- Last updated
- 2021-12-01
Locations
2 sites across 1 country: Singapore
Source: ClinicalTrials.gov record NCT04620954. Inclusion in this directory is not an endorsement.