Back to search results

Phase II Study of Nivolumab and Relatlimab for Melanoma Brain Metastases

This study is looking at whether a combination of two drugs, nivolumab and relatlimab, can help control melanoma that has spread to the brain (melanoma brain metastases). Both drugs are given through an IV (into a vein). Researchers will also be studying the safety and side effects of this drug combination. The main goal is to see how many patients respond to the treatment in their brain tumors. They will also look at overall survival and how long patients live without their cancer getting worse. You may be able to join if you are 18 or older and have a life expectancy of more than 12 weeks. The study plans to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events through study completion, which is an average of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05704647

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~30 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:BMS-986213 (Relatlimab-Nivolumab FDC)NivolumabRelatlimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 2 years

Conditions

Melanoma (Skin)

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Hussein Tawbi, MD, PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Hussein Tawbi, MD,PHD
[email protected]
(713) 792-4185
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Tumor tissue should be of good quality based on total and viable tumor content.
Patients who do not have tissue specimens may undergo a biopsy during the screening period. Acceptable samples include core-needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Fine Needle Aspirations (FNA) will not be considered acceptable for tissue procurement.
Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable.
However, if repeat biopsy is not feasible, and no archival tissue available patient still may be enrolled. 7. Prior SRT and prior excision of up to 5 MBM is permitted if there has been complete recovery, with no neurologic sequelae, and measurable non irradiated lesions remain. 8. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable.

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 2 years