drugset / Trial / NCT03734692
Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
Phase 1/2
Active not recruiting
24 enrolled
Robert Edwards
AIM ImmunoTech Inc. · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II single arm efficacy/safety trial that will evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP rintatolimod (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab (IVP) for patients with recurrent platinum-sensitive ovarian cancer (OC).
Timeline
- Start
- 2019-01-28
- Primary completion
- 2024-07-01
- Completion
- 2027-01-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 50 mg/m2 | Other |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Rintatolimod | Oligonucleotide (other) | 200 mg | Other |