melanoma
Conditions
Interventions
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. ECOG 0-1; 3. Patients with resected acral malignant melanoma staged by histopathological stage IIB-IIID; 4. Did not receive any treatment except resection before operation; 5. Postoperatively assessed as high risk; 6. Confirm the BRAF status before treatment; 7. Confirm the CPS status before treatment; 8. The investigator believes that the enrolled patients can safely receive adjuvant pembrolizumab therapy; 9. Surgical resection to the first medication <= 12 weeks; 10. Normal bone marrow and organ functions; 11. Female and male participants with reproductive potential must agree to use appropriate contraception during the entire study period and within 120 days after the last study treatment; 12. Female patients are not pregnant or breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Suffering from ocular melanoma; 2. Female subjects with a positive urine pregnancy test (with or without cisplatin) within 72 hours before the start of the study or within 24 hours after starting radiotherapy; 3. Diagnosed with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrollment; 4. In the past 3 years, there are other malignant tumors that are known to be progressing or require active treatment, except skin basal cell carcinoma, skin squamous cell carcinoma or carcinoma in situ (such as cervical carcinoma in situ or breast cancer); 5. With radiologically detectable (even asymptomatic and/or previously treated) central nervous system metastases and/or cancerous meningitis; 6. Hearing loss detection >= level 2 (according to the average hearing loss of 500, 1000, 2000 and 4000Hz, the degree of hearing loss is divided into 5 levels: 26~40dB is mild, 41~55dB is moderate, 56~70dB is moderately severe , 71~90dB is severe, and greater than 90dB is extremely severe.); 7. Mental illness grade >= 2 (one or two of the five items are rated as 2 points, and the five items are: self-care ability of personal life, performance of family life functions, care and responsibility for family members, occupational labor ability, social interaction mobility: 0 points for normal or mild abnormalities, 1 point for functional defects, 2 points for severe functional defects); 8. Grade 3-4 hemorrhage due to potential malignancy; 9. Has undergone surgery before starting the study or has not fully recovered from toxicity or complications caused by the intervention; 10. Have had allogeneic tissue/solid organ transplantation; 11. Severe hypersensitivity to pembrolizumab (>= grade 3); 12. Suffering from active autoimmune disease, requiring systemic treatment in the past 2 years; 13. Have a history of (non-infectious) pneumonia that requires steroid treatment; 14. Suffering from active infection and requiring systemic treatment; 15. Has a history of human immunodeficiency virus (HIV) infection; 16. Have a history of hepatitis B or hepatitis B virus positive (defined as hepatitis B surface antigen [HBsAg] positive reaction (GMT greater than 2000 mIU/ml)) or active hepatitis C (defined as detection of hepatitis C virus [HCV] ribonucleic acid); 17. Has any medical history, treatment or laboratory abnormalities that may confound the study results, interfere with the participant's participation throughout the study period, or be detrimental to the participant's best interests; 18. Has a known history of psychiatric or substance use disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Distant Metastasis-Free Survival (DMFS);Overall Survival (OS);Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactLibin Xu
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed