drugset / Trial / NCT07634094
Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer
Phase 2
Not yet recruiting
28 enrolled
Kalinski, Pawel, MD, PhD
AIM ImmunoTech Inc. · collabNorthwest Biotherapeutics · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This trial proposes to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) in the primary neoadjuvant setting. It was previously determined the tolerable dose of IPC-CKM. This study will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen and systemic Keytruda (pembrolizumab). To optimize the pattern of immunity, all patients will also receive oral celecoxib (COX2 inhibitor).
Timeline
- Start
- 2026-08
- Primary completion
- 2028-08
- Completion
- 2029-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Other |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Rintatolimod | Oligonucleotide (other) | 200 mg | Other |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 6e+06 iu | Other |
| Subject | αDC1 Vaccine | Vaccine | 6e+06 cells | Other |
| Background | Celecoxib | Other / unclassified | 200 mg | Oral |