drugset / Trial / NCT02716805

Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant

NCT02716805

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

EvaluationDrugModalityDoseRoute
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

Indications