Last updated on March 2020

Dose Escalation and Efficacy Study of mRNA 2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Patients With Advanced Malignancies


Brief description of study

This clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2416 alone and in combination with intravenously administered flat doses of durvalumab in patients with relapsed/refractory solid tumor malignancies or lymphoma, as well as the objective response rate (ORR) of mRNA-2416 alone or in combination with durvalumab in ovarian cancer based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Detailed Study Description

This is a first-in-human, Phase 1, open-label, multicenter, dose escalation and efficacy study designed to determine the safety and tolerability of repeated intratumoral injections of mRNA-2416 alone (Arm A) and in combination with intravenously administered durvalumab (Arm B) in patients with advanced relapsed/refractory solid tumor malignancies or lymphoma and to assess the ORR of mRNA-2416 alone and in combination with durvalumab in ovarian cancer based on RECIST v1.1. The study includes 2 treatment arms (mRNA-2416 monotherapy (Arm A),and mRNA-2416 + durvalumab (Arm B)), each arm of the study consists of a Dose Escalation period in non-visceral lesions followed by a Dose Confirmation period in visceral lesions and an Expansion period in patients with ovarian cancer at the MTD/RDE as determined by the Dose Escalation period. Once the expected MTD/RDE has been cleared in Dose Escalation for Arm A, Dose Escalation for Arm B will begin with mRNA-2416 at 1 dose level lower than the Arm A MTD/RDE.

Clinical Study Identifier: NCT03323398

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