MedTrace Logo

Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma

NCT05304546 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-07-22

No results posted yet for this study

Summary

This study will enroll metastatic (Stage IV or inoperable stage III) melanoma (MM) patients carrying a BRAF V600E/K mutation with confirmed primary resistance to standard of care immunotherapy (single agent PD-1 or a combination of CTLA-4/PD-1 blockade). Patients must be naïve to therapy with BRAF+MEK inhibitors, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Conditions

Interventions

DRUG

Pembrolizumab

Solution for IV

DRUG

Encorafenib

Oral QD

DRUG

Binimetinib

Oral BID

Sponsors & Collaborators

  • Dr. Ronnie Shapira

    lead OTHER_GOV

Principal Investigators

  • Ronnie Shapira-Frommer, Dr · Ella Lemelbaum Institute for Immuno-Oncology & Melanoma, Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2025-07-17
Completion
2025-07-17

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05304546 on ClinicalTrials.gov