Health TrialsbyHealthPanel

A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma

ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at the time of informed consent

Patient/legal authorized representative (LAR) must be able to provide informed consent.

For Cohort B, the patient's melanoma must have progressed on prior combination PD-1 + LAG-3 blockade

Note: Intervening lines of targeted therapy, chemotherapy, bispecific (e.g. IMCgp100) and cell-based therapies are permitted between last ICI-based therapy and the start of study therapy

Disqualifiers

Uveal melanoma

Untreated central nervous system (CNS) metastases or leptomeningeal involvement; patients with brain metastases definitively treated with surgery or stereotactic radiosurgery (SRS) are permitted

For Cohort A: Any prior anti-LAG-3 (e.g., relatlimab) or CTLA-4 (e.g., ipilimumab) directed therapy, unless it was given in the adjuvant or neoadjuvant setting and the last dose was given more than three months prior to disease recurrence

For Cohort B: Any prior CTLA-directed therapy (e.g., ipilimumab), unless it was given in the adjuvant or neoadjuvant setting and the last dose was given more than three months prior to disease recurrence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fianlimab

    Drug

    Fianlimab IV given every three weeks

  • Cemiplimab

    Drug

    Cemiplimab IV given every three weeks

  • Ipilimumab

    Drug

    Ipilimumab will be give every 6 weeks continuously

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Refractory melanoma after PD-1 monotherapy (Cohort A)Experimental treatment 3 interventions
Group B: Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Determine best objective response rate (ORR) (cohort A)

by RECIST v1.1

Time frame
6 weeks
2

Determine best objective response rate (ORR) (cohort B)

by RECIST v1.1

Time frame
6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Memorial Sloan Kettering Cancer Center

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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