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GC101 TIL in Advanced Melanoma
NCT06703398Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- May 2026
- Countries
- 1
- Sponsor
- Juncell Therapeutics
- Modality
- Cell Therapies
- Drugs
- nolgileucel
- Conditions
- melanoma
01
Overview
Phase 2, randomised, open-label trial of nolgileucel in melanoma (2 arms), sponsored by Juncell Therapeutics. Primary endpoint: Progression-Free Survival at 12 months. Started Dec 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
GC101 TIL group
GC101 TIL + sintilimab after lymphodepletion
Investigator's choice of chemotherapy
Dacarbazine, temozolomide, paclitaxel, carboplatin or cisplatin
03
Who it enrols
Patients aged 18-75 with unresectable advanced, recurrent or metastatic melanoma (excluding uveal) who have failed PD-1 antibodies and at least two prior systemic therapies, with an ECOG of 0-1 and expected survival >3 months.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Progression-Free Survival
Objective Response Rate
Disease Control Rates
Duration of Response
Adverse Events
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