drugset / Trial / NCT02716805
Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant
Phase 1
Terminated
6 enrolled
Ludwig Institute for Cancer Research
Cancer Research Institute, New York City · collabMedImmune LLC · collabMultiple Myeloma Research Foundation · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This was a Phase 1, open-label, multicenter, study of checkpoint inhibitor therapy (tremelimumab ± durvalumab) prior to and following autologous stem cell transplant (ASCT) and high-dose melphalan in subjects with multiple myeloma who were at a high risk for relapse, were eligible for ASCT, and had available cryopreserved stem cells. Primary study objectives were to determine the safety and tolerability of study treatment. Further objectives were to evaluate the clinical efficacy and biologic activity of the regimen.
Timeline
- Start
- 2016-12-13
- Primary completion
- 2018-02-16
- Completion
- 2018-02-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | Intravenous |
| Background | Melphalan | Small molecule | 200 mg/m2 | Intravenous |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |