FLX475 in Combination With Ipilimumab in Advanced Melanoma

RAPT Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Advanced Melanoma

Treatments: Drug: FLX475; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04894994

FLX475-03

Details and patient eligibility

About

This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.

The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IV or unresectable Stage III advanced melanoma
• Prior treatment with at least 2 months of anti-PD-(L)1 agent
• Measurable disease at baseline
• Tumor available for biopsy

Exclusion criteria

• History of allergy or severe hypersensitivity to biologic agents
• History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
• Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

FLX475 and ipilimumab combination therapy

Experimental group

Description:

Participants received FLX475 tablets orally and ipilimumab by IV infusions

Treatment:

Drug: Ipilimumab

Drug: FLX475