Overview

A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)

Status:
Terminated

Trial end date:
2020-10-08

Target enrollment:

Participant gender:

Summary

The study consists of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase will evaluate the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase will assess the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who have completed the combination treatment of avelumab at a given dose level of M9241, a safety review will be performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects will be treated with escalating doses of M9241 with avelumab intravenous (IV).

Phase:

Phase 1

Details

Lead Sponsor:

EMD Serono
EMD Serono Research & Development Institute, Inc.

Collaborators:

Merck KGaA
Merck KGaA, Darmstadt, Germany

Treatments:

Antibodies, Monoclonal
Avelumab
Immunoglobulin G
Interleukin-12