OncoMatch/Clinical Trials/NCT06703398
A Study of GC101 TIL in Advanced Melanoma
Is NCT06703398 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including GC101 TIL and dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin for melanoma.
Treatment: GC101 TIL · dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin — 98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Allowed: BRAF V600 mutation
if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor
Allowed: NRAS mutation
if knowed with NRAS mutate, then need to failed to Tunlametinib
Disease stage
Required: Stage IV
Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma); There are still at least 1 measurable lesion (according to RECIST1.1 criteria ) even after TIL sampling and resection of surgically resectable tissue
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
Patients who have failed or resisted to PD-1 antibodies
Must have received: systemic therapy
Patients must have failed or resisted to at least two frontlines systemic tehrapy
Must have received: BRAF inhibitor
if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor
Must have received: MEK inhibitor
if knowed with BRAF V600 mutate, then need to failed to BRAF/MEK inhibitor
Must have received: MEK inhibitor (Tunlametinib)
if knowed with NRAS mutate, then need to failed to Tunlametinib
Cannot have received: TIL cell therapy
Exception: within 6 months
There is a history of TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months
Cannot have received: allogeneic T cell therapy
Exception: within 6 months
There is a history of TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months
Cannot have received: NK cell therapy
Exception: within 6 months
There is a history of TIL cell therapy, allogeneic T cell therapy, or NK cell therapy within 6 months
Cannot have received: drug under study
Exception: within 28 days prior to screening
Patients receive any drug under study within 28 days prior to screening
Lab requirements
Blood counts
With sufficient hematology
Kidney function
With sufficient end-organ function
Liver function
With sufficient end-organ function
With sufficient hematology and end-organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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