Oregovomab and PLD in PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
Summary
This study is phase II, open label, clinical trial to determine the efficacy of Oregovomab and non-platinum chemotherapy in PARP inhibitor resistant ovarian, fallopian tube, or primary peritoneal cancer patients who were not suitable for platinum retreatment. Patients who have received one to three prior lines of chemotherapy are to be assigned to Cohort 1 (oregovamab 2 mg \[C1,2,3,5,7 for five doses\] + pegylated liposomal doxorubicin \[PLD\] 40 mg/m2 q4w, n=28), while patients who have received more than three prior lines of chemotherapy are to be assigned to Cohort 2 (oregovamab 2 mg \[C1,2,3,5,7 for five doses\] + weekly paclitaxel 80 mg/m2 \[D1,8,15 q4w\], n=28). A total of 56 patients will be recruited and treated with oregovomab + PLD / weekly paclitaxel until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint is objective response rate by RECIST 1.1.
Timeline
- Start
- 2022-07-05
- Primary completion
- 2024-05
- Completion
- 2024-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Oregovomab | Monoclonal antibody | 2 mg | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
Indications
No indication recorded.