melanoma
Conditions
Interventions
Treatment group:Stereotactic radiotherapy (SRT) combined with zimberelimab (GLS-010)
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed the informed consent; 2. Aged 18-75 years (calculated on the day of signing the informed consent, including the boundary value), no gender limit; 3. AJCC stage IV (any T, any N, M1c) pathologically confirmed malignant melanoma or primary malignant melanoma of unknown primary site; Note: Confirmation of pathological reports such as histology or cytology of the original primary tumor is required; 4. Have at least one imaging-evaluable (RECIST1.1) brain metastases; 5. ECOG physical status score is 0-2; 6. The function of the patient's vital organs meets the following requirements: absolute neutrophil count >= 1.5 x 10^9/L; platelets >= 100 x 10^9/L; hemoglobin >= 10 g/dL; bilirubin = 50 ml/min; activated partial thromboplastin time (APTT) and international normalized ratio (INR 3 months; 9. Patients with reproductive potential voluntarily use effective contraceptive methods during the study period and within 6 months of the last study medication, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless the female patient has undergone natural menopause, artificial menopause, or sterilization (eg, hysterectomy, bilateral adnexectomy, or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1. Any untreated intracranial disease; 2. Patients with previous cancers, except for the following patients: (1) Diagnosed 5 years ago with no evidence of disease recurrence during this period; (2) Successfully treated basal cell or squamous cell skin cancer; (3) Carcinoma in situ of the cervix; 3. Have a medical or psychiatric condition that impairs the ability to give informed consent or complete the protocol; (Women of reproductive potential) positive urine pregnancy test (within 7 days after randomization into the trial); 4. The patient is using immunosuppressive agents and is still using it within 2 weeks before enrollment; 5. The patient has any active autoimmune disease or has a history of autoimmune disease; 6. Patients with Treponema pallidum infection, hepatitis C virus antibody, human immunodeficiency virus (HIV) positive; 7. Patients who are pregnant or breastfeeding; or women of childbearing age who have a positive blood pregnancy test during screening; 8. Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery; congestive heart failure New York Heart Association (NYHA) class > 2; ventricular arrhythmia requiring medical treatment; LVEF (left ventricular ejection fraction) 1.5 or partially activated prothrombin time (APTT) > 1.5 x ULN), those with bleeding tendency (e.g. active ulcer lesions in the stomach, black stool and/or hematemesis and hemoptysis within 3 months); 13. The urine routine indicates that the urine protein is >= 2+, and the 24-hour urine protein amount is greater than 1.0 g; 14. Adjusted QT interval > 470 msec; if the patient has QT interval prolongation, but the reason for the prolongation is the pacemaker (and no other cardiac abnormalities) as assessed by the investigator, the investigator will decide whether the patient is suitable for the study; 15. Patients with severe allergic reactions to monoclonal antibodies and history of uncontrolled allergic asthma are known to be allergic to drug components; 16. Those who have received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 17. Past or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, organizing pneumonia, drug-induced pneumonia, or with active pneumonia on CT during screening; 18. Any active infection that requires systemic treatment by intravenous infusion within 14 days before screening; 19. Those who have used radiopharmaceuticals (strontium, samarium, etc.) within 56 days before screening; 20. Received live attenuated vaccine within 14 days before screening or planned to receive during the study; 21. Other situations that may increase the risk associated with the study drug, or interfere with the interpretation of the study results, and affect the test compliance and other c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Extracranial response rate;Overall survival;Intracranial disease progression-free survival;Extracranial disease progression-free survival;Overall progression-free survival;Neurocognitive function;Quality of life (QoL);Performance status;Death from intracranial causes; | — |
Countries
China
Contacts
Public ContactLi Jinluan
Fujian Cancer Hospital
Outcome results
None listed