drugset / Trial / NCT03875079

A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma

NCT03875079

Phase 1 Completed 83 enrolled Hoffmann-La Roche
RandomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period.

Timeline

Start
2019-06-24
Primary completion
2022-07-14
Completion
2022-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject simlukafusp alfa Protein / enzyme biologic 10 mg Intravenous

Indications