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Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma

NCT04655157 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-05-23

Study results available
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Summary

Patients with unresectable or metastatic BRAF-mutant melanoma high-risk patients will be given 450 mg orally (PO) daily (QD) plus binimetinib 45 mg PO twice daily (BID) together with nivolumab administered intravenously (IV) at 3mg/kg and ipilimumab administered IV at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab administered IV at 480mg every 4 weeks until progression or discontinuation due to toxicity. Concurrently, a triple therapy arm will be explored with encorafenib 300 mg PO QD together with ipilimumab administered IV at 1mg/kg and nivolumab 3mg/kg IV every 3 weeks for 4 doses, followed by nivolumab administered at 480mg every 4 weeks until progression or discontinuation due to toxicity. Tolerability of the two arms will be compared, and a recommended phase 2 dose (RP2D) will be determined. After determination of treatment schedule, expansion cohorts will further explore the preliminary efficacy and further describe the toxicity profile of the triplet or quadruplet regimen in high-risk cohorts including symptomatic brain metastases or liver metastases with elevated lactate dehydrogenase (LDH) or bulky systemic disease burden.

Conditions

Interventions

DRUG

encorafenib

A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.

DRUG

nivolumab

A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.

DRUG

ipilimumab

A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.

DRUG

binimetinib

A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Sponsors & Collaborators

Principal Investigators

  • Jason J Luke, MD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2022-08-03
Completion
2022-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases
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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 NCT04655157 on ClinicalTrials.gov