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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05704647
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma (Skin)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.

Key Dates

Start date
Feb 23, 2023
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Relatlimab+Nivolumab
    Participants will receive nivolumab in combination with relatlimab by vein over about 30 minutes on Day 1 of each 28-day study cycle. You may receive up to 25 doses of the study drugs.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Hussein Tawbi, MD,PHD
[email protected]
713-792-4185
Hussein Tawbi, MD,PHD (PRINCIPAL_INVESTIGATOR)

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M D Anderson Cancer Center· Houston, TX

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