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Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

NCT02902042 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-02-16

No results posted yet for this study

Summary

This study will investigate the influence of maintenance therapy on progression-free survival (PFS) and overall survival (OS) after combination therapy with BRAF/MEK (MAP-ERK kinase) inhibitors and PD-1 antibody pembrolizumab.

In the safety phase I part the optimal dose of pembrolizumab in combination with BRAF inhibitor and MEK inhibitor and the safety of this three-drugs-combination regime will be determined.

In the randomized part 2 different maintenance therapies will be tested for toxicity and efficacy. Patients with disease control after 6 months of triple therapy will be randomized to receive 2 different maintenance therapies further on, either continuation of triple therapy or administration of pembrolizumab alone.

Conditions

  • Malignant Melanoma

Interventions

DRUG

Encorafenib

Dose determined in phase I. Start dose: 450 mg qd

DRUG

Binimetinib

Dose determined in phase I. Start dose: 45 mg bid

DRUG

Pembrolizumab

Dose determined in phase I. Start dose: 200 mg q3w

DRUG

Pembrolizumab alone

200 mg q3w

Sponsors & Collaborators

  • Prof. Dr. med. Dirk Schadendorf

    lead OTHER

Principal Investigators

  • Dirk Schadendorf, Prof. Dr. · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902042 on ClinicalTrials.gov