melanoma
Conditions
Interventions
Experimental group:Pembrolizumab combined with Temozolomide
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged >= 18 years on the day of signing the informed consent form, no gender limit, with histopathologically confirmed recurrent, unresectable or metastatic acral melanoma (stage III/IV). 2. BRAF wild-type, or mutant subjects who were intolerant or failed standard targeted drug therapy. 3. Subjects who have used adjuvant/neoadjuvant therapy are allowed to enroll: (1) If PD(L)-1 or TMZ/DTIC is included in the adjuvant or neoadjuvant treatment regimen, only those who have progressed more than 6 months after the end of the treatment regimen can be enrolled; (2) If PD(L)-1 or TMZ/DTIC is not included in the adjuvant or neoadjuvant therapy regimen, those who progress during adjuvant therapy are allowed to be enrolled. 4. (Female subjects of childbearing age) The urine or serum pregnancy test must be negative within 1 week before receiving the first dose of study drug. If the urine test results are positive or borderline, a serum pregnancy test is required. 5. Male subjects must agree to take the contraceptive measures detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment, and refrain from sperm donation during this time. 6. Female subjects who are not pregnant (see Appendix 3) or breastfeeding, and who meet at least one of the following conditions can participate in this study: (1) Not women of childbearing age (WOCBP) as defined in Appendix 3; (2) Agree to follow the WOCBP of contraceptive guidance provided in Appendix 3 during treatment and at least 6 months after the last study treatment administration. 7. Subjects (or legal representatives, if applicable) provide written informed consent for this study. 8. Based on RECIST 1.1, with measurable disease. Archived tumor tissue samples or fresh biopsies (without prior radiation therapy) are acceptable. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are superior to pathological slides. Fresh biopsy tissue is preferred over archived tissue. 9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. The ECOG assessment should be performed within 7 days of the study treatment day. 10. Have appropriate organ function as defined in the table below (Table 2). Samples must be collected within 10 days of starting study treatment.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibitory T cell receptor (eg CTLA-4, OX-40, CD137). 2. Received systemic antitumor therapy, including experimental drugs, 4 weeks ago. 3. Received radiotherapy within 2 weeks before the start of study treatment. Subjects had to recover from all radiation-related toxicities, not receive corticosteroids, and not have radiation pneumonitis. Palliative radiotherapy (= grade 3) to pembrolizumab and/or any of its excipients. 10. Has active autoimmune disease requiring systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years. 11. History of (non-infectious) pneumonitis requiring steroids or current pneumonitis. 12. Has an active infection requiring systemic treatment. 13. Positive HIV antibody, or positive HCV antibody/HCV-RNA, or positive HBsAg or HBcAb (when HBV DNA copy>500 IU/ml); 14. Have a known history of active TB (pulmonary tuberculosis). 15. The treatment investigator believes that past or current existence may interfere with the results of this study and affect the participation of subjects in the entire research process, or explain the disease, treatment, or abnormal laboratory test for which participation in the research cannot bring the greatest benefit to the subjects. 16. Psychosis or substance abuse is known to interfere with normal trial cooperation requirements. 17. Subjects who were pregnant or breastfeeding, or intended to have childre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactZhang Xiaoshi
Sun Yat-sen University Cancer Center
Outcome results
None listed