Phase 2b RAPA-201 Cell Therapy for Melanoma After PD-(L)1 Treatment
This study is testing a new cell therapy called RAPA-201 for people with advanced melanoma that has spread or cannot be removed, and has not responded to previous anti-PD-(L)1 immunotherapy. RAPA-201 uses your own immune cells (T cells) that are specially treated to fight cancer. Before receiving RAPA-201, you will have chemotherapy with Carboplatin and Paclitaxel. The study aims to see how well RAPA-201 works in shrinking tumors or stopping their growth. You might be eligible if you are at least 18 years old, have a good general health status, and your melanoma has progressed despite prior anti-PD-(L)1 treatment. The study plans to enroll 65 participants.
- Study design
- This is a Phase 2, non-randomized, open-label study involving multiple sites, designed to enroll 65 participants.
- What's involved
- Participants will receive RAPA-201 therapy, which is given in an outpatient setting, and will have 6 months of treatment followed by 12 months of clinical follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after 6 months of treatment to assess the effectiveness of RAPA-201 cell therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Daniel Fowler, M.D. · STUDY_DIRECTOR · Rapa Therapeutics
Who to contact
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What this trial measures
- Efficacy of RAPA-201 Cell Therapy18 months (6 mo. of treatment; 12 mo of clinical follow-up)
In an intent-to-treat (ITT) manner, the efficacy of RAPA-201 cell therapy will be determined by overall response rate (ORR) in metastatic melanoma patients with progressive disease after anti-PD-(L)1 therapy, as assessed by the independent review committee (IRC) per iRECIST v1.1.