Health TrialsbyHealthPanel

A Study of GC101 TIL in Advanced Melanoma

ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;

Aged ≥18 years and ≤75 years, regardless of gender;

Patients with unresectable advanced, recurrent or metastatic melanoma (excluding uveal melanoma) ;

Patients who have failed or resisted to PD-1 antibodies；

Disqualifiers

Patients receive any drug under study within 28 days prior to screening;

Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;

Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;

Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, hypothyroidism etc., which in the judgment of the investigator pose no safety risk);

Trial design

Design model

Parallel

Treatments tested in this trial

  • GC101 TIL

    Biological/Vaccine

    Patients with advanced melanoma (excluding uveal melanoma) who have failed to PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed; if NRAS mutation is present, tunlametinib have failed) and are ineligible for resection

  • dacarbazine, temozolomide, paclitaxel ,platinum or cisplatin

    Drug

    monotherapy or combination of dacarbazine, temozolomide, paclitaxel, platinum or cisplatun, and the chemotherapy's dosage could refer to the drug label or the relevant treatment guideline, the final decision is up to investigator

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: GC101 TIL groupExperimental treatment 1 intervention
Group B: Investigator's choice of chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Progression-free survival (PFS) confirmed by the Independent Review Committee (IRC) according to RECIST 1.1

Time frame
Every 6 weeks for 12 months

Secondary outcomes

1

Overall survival

Overall survival (OS) and OS rates at 6, 12, and 18 months

Time frame
Maximum 2 years
2

Progression-free survival

PFS assessed by investigators according to RECIST 1.1 and PFS assessed by IRC and investigators according to iRECIST

Time frame
Every 6 weeks for 12 months
3

Objective Response Rate

Objective Response Rate (ORR) assessed by IRC and investigators according to RECIST 1.1 and iRECIST

Time frame
Maximum 360 days
4

Disease Control Rates

Disease Control Rates (DCR) assessed by IRC and investigators according to RECIST 1.1 and iRECIST

Time frame
Every 6 weeks for 12 months

Other outcomes

Sponsors and contacts

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

Shanghai Juncell Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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