Melanoma
Conditions
Keywords
Mitogen-Activated Protein Kinase Kinases, NRAS, Melanoma
Brief summary
This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.
Detailed description
A total of 165 subjects will be included and randomly assigned to the corresponding treatment group in a 2:1 ratio by Interactive Web Response System（IWRS）. Experimental group: subjects received continuous administration of tunlametinib capsules every 28 days, and the study treatment was terminated until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigators, or when the study was terminated (whichever occurred earlier). Control group: subjects received the combination chemotherapy (paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin, investigator's choice according to the conditions of the subjects) every 28 days until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigator or when the study was terminated (whichever occurred earlier). Efficacy was evaluated by independent radiology review committee and the investigator, respectively. Within 30 days after the last administration of the study drug, the safety of the subjects will also be closely monitored and recorded. After safety visit or the last administration of the study drug (whichever occurs later), subject survival follow-up is conducted every 12 weeks to confirm the survival status and record new anti-tumor treatment until death, lost to follow-up, withdrawal of informed consent, or the end of this study (whichever occurs earlier).
Interventions
DRUGtunlametinib
12mg BID
DRUGpaclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin
according to investigators' suggestion
Sponsors
Shanghai Kechow Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age. 2. Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology. 3. History of immunotherapy failure or could not tolerate immunotherapy 4. NRAS mutation at baseline;. 5. There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 6. Eastern cooperative oncology group (ECOG) performance status of grade 0-1. 7. Life expectancy \> 3 months. 8. No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 4weeks prior to investigational drug administration. 9. Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings. 10. Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria: 11. Able to understand and voluntarily sign the Informed Consent Form. 12. Patients must be willing and able to complete the study procedure and follow-up examination.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival(PFS) | up to 12 months | defined as the time from first dose to the earliest documented disease progression or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival(OS) | up to 12 months | defined as the time from the date of taking drugs to the date of death due to any cause |
| Duration of response(DOR) | up to 12 months | Duration of response is defined as subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death |
| Disease control rate(DCR) | up to 12 months | Proportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death |
Countries
China
Contacts
Primary ContactLixia Gong, Master
Outcome results
None listed