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
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
Treatments tested in this trial
- LM103 TILs Injection
- Dacarbazine, temozolomide, paclitaxel, carboplatin/cisplatin
Treatment groups
92 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov