Health TrialsbyHealthPanel

A Phase II Trial of LM103 in Advanced Melanoma

ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou BlueHorse Therapeutics Co., Ltd.

About this trial

A total of 92 subjects with advanced melanoma who met the inclusion criteria will be randomly assigned in a 1:1 ratio to the experimental group and the control group in this phase II trial. The study will be followed up until 24 months after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At the date of signing Informed Consent Form (ICF), 18 ~75 years old, male or female;

Expected survival time >3 months;

ECOG performance status 0-1;

Patients with unresectable recurrent/metastatic melanoma (excluding uveal melanoma) who have failed at least two lines of standard treatment: • Patients need to have failed or be intolerant to PD-1 antibody treatment; • If the BRAF V600 mutation is positive, treatment with BRAF±MEK inhibitors must fail; • If the NRAS mutation is positive, treatment with Tunlametinib must fail;

Disqualifiers

A history of other malignant tumors within the past 5 years, excluding malignant tumors that can be expected to heal after treatment (including but not limited to well-treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery);

Adverse reactions caused by previous treatments have not been recovered to grade ≤1(CTCAE V5.0) (excluding the laboratory tests from the inclusion criteria, alopecia and neurotoxicity, and hypothyroidism, adrenal insufficiency and hypopituitarism that cannot be restored to grade 2 as determined by the investigators for a long time);

Any immune-related adverse reaction (irAE) with a severity level greater than grade 3 that has occurred during any previous immunotherapy and has been permanently discontinued;

Have received vaccination within two months prior to tumor tissue procurement surgery, or plan to receive vaccination during the study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • LM103 TILs Injection

    Biological/Vaccine

    Extract, culture and expand tumor-infiltrating lymphocytes from resected tumor tissues in vitro for the manufactur of LM103 TILs injection. After NMA-LD, the subjects received LM103 infusion and followed by IL-2 supportive treatment.

  • Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin

    Drug

    The subjects will start treatment with a chemotherapy regimen selected by the investigators, including dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: LM103 TILs GroupExperimental treatment 1 intervention
Group B: Chemotherapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

PFS confirmed by the Independent Review Committee (IRC) according to RECIST 1.1

Time frame
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

Secondary outcomes

1

Overall survival (OS)

OS and OS rates in 6, 12, 18, 24 months

Time frame
Maximum 24 months
2

PFS

PFS confirmed by the investigators according to RECIST 1.1

Time frame
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
3

Objective Response Rate (ORR)

ORR assessed by IRC and investigators according to RECIST 1.1

Time frame
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months
4

Disease Control Rates (DCR)

DCR assessed by IRC and investigators according to RECIST 1.1

Time frame
Every 6 weeks in the first 6 months after treatment and every 12 weeks from 6 months to 24 months

Other outcomes

Sponsors and contacts

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

Suzhou BlueHorse Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now