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Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

ConditionsMelanomaBrain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed non-uveal melanoma that has metastasized to the brain. At least 1 measurable intracranial target lesion (5-40mm) which was not previously treated with local therapy (no prior SRS to this lesion). Prior surgery for a brain metastasis is allowed but this lesion cannot be a target lesion.

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for Cohort A (asymptomatic), ECOG performance status 0-2 for Cohort B (symptomatic)

No prior anti-CTLA-4, anti-PD-1, or anti-LAG-3 therapy for unresectable stage III/IV melanoma. Prior CTLA-4, PD-1, and/or LAG-3 therapy in the neoadjuvant or adjuvant setting is acceptable if >6 months since last treatment. Participants may have had prior BRAF+MEK inhibitors for adjuvant therapy and/or unresectable/metastatic melanoma if >2 weeks have elapsed since last treatment.

Disqualifiers

Another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated).

Active medical illness(es) that would pose increased risk for study participation, including: active systemic infections (including COVID-19), coagulation disorders, or other major active medical illnesses of the cardiovascular, respiratory, or immune systems.

Active autoimmune disease that has required systemic therapy with corticosteroids or other immunosuppressive agents within the past 3 years (excluding immune-related adverse events from immunotherapy as described above.

Implanted device that precludes the use of MRI.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ipilimumab

    Drug

    1 mg/kg of Ipilimumab will be administered via IV every 8 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur

  • Nivolumab + Relatlimab FDC

    Drug

    Relatlimab 160mg + Nivo 480mg will be administered via IV every 4 weeks. Participants will be assigned to Cohort A or B as per eligibility criteria. No randomization or blinding will occur

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cohort A: AsymptomaticExperimental treatment 2 interventions
Group B: Cohort B: SymptomaticExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Intracranial clinical benefit rate

Intracranial clinical benefit rate, defined as the percentage of patients who had a complete response (CR), partial response (PR), or stable disease for at least 6 months per modified RECIST 1.1 criteria.

Time frame
6 months

Secondary outcomes

1

Evaluation of Safety and Adverse Events Using CTCAE v5.0

Safety will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Time frame
6 months
2

Extracranial objective response rate

Extracranial objective response rate, defined as the percentage of patients who had a complete response (CR) or partial response (PR) per RECIST 1.1 criteria.

Time frame
6 months
3

Global objective response rate

Global objective response rate, defined as the percentage of patients who had a complete response (CR) or partial response (PR) per modified RECIST 1.1 criteria.

Time frame
6 months
4

Extracranial clinical benefit rate

Extracranial clinical benefit rate, defined as the percentage of patients who had a complete response (CR), partial response (PR), or stable disease for at least 6 months per RECIST 1.1 criteria.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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