melanoma
Conditions
Interventions
Combination therapy arm:PD-1 Monoclonal Antibody in Combination with Interferon Alpha 1b
Sponsors
Xijing Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patients must have stage IV unresectable melanoma confirmed by histology or cytology (except for uveal melanoma, the total proportion of patients with mucosal malignant melanoma will not exceed 22%); 2. The patient has not received systemic treatment, and has not received PD-1 mAb or PD-L1 mAb or PD-L2 mAb; 3. Patients with expected survival time >= 3 months; 4. Patients willing to provide tumor tissue and blood samples for gene and transcriptome testing; 5. According to recist1.1, patients with at least one measurable lesion (except for one measurable lymph node lesion, which has not received radiotherapy); Note 1: tumor lesions from previous radiotherapy sites are considered to be measurable if they demonstrate progress at the time of study enrollment. Note 2: in this study, skin lesions and other superficial lesions were not considered as measurable lesions, but as non target lesions; 6. The patient has passed the written informed consent and voluntarily participated in the experiment. The age of the day when the informed consent was signed was between 18 and 75 years old; 7. The ECoG physical fitness score of patients must be 0 or 1; 8. Patients whose organ function evaluation meets the entry conditions are shown in the following laboratory test values (within 4 weeks before the start of drug treatment): (1) Neutrophil absolute count (ANC) >= 1.5 * 10^9 / L (2) Platelet >= 100 * 10^9 / L (3) Hemoglobin >= 90g / L (no blood transfusion within 14 days before admission) (4) Serum creatinine <= 1.5 * upper limit of normal value (ULN) (5) Serum total bilirubin <= 1.5 * ULN (6) Ast (SGOT) and ALT (SGPT) <= 2.5 * ULN or <= 5 * ULN (patients with liver metastasis) (7) Prothrombin time (PT), international standard ratio (INR), activated partial thromboplastin Time (APTT): < 1.5 times ULN (unless the subject is receiving anticoagulant treatment, as long as Pt or APTT is within the treatment range of expected anticoagulant use); 9. The pregnant women with fertility were negative in urine or serum pregnancy test within 7 days before receiving the first dose of study drug; 10. Female patients enrolled in the study must be willing to use appropriate methods of contraception until 12 months after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Patients who were intolerant to interferon adjuvant therapy in the past; 2. Patients who are currently participating in or have participated in clinical research of drugs or clinical research of medical devices within 4 weeks before the first administration of research drugs; 3. Patients are expected to require any other form of systemic or local anti-tumor treatment during the study period; 4. The patients received systemic steroid treatment (> 10mg / kg prednisone or equivalent dose) or any other form of immunosuppressive drug treatment within two weeks before the first dose; 5. The patient has a known history of hematological malignancy, primary brain tumor, sarcoma or other primary solid tumor, unless the patient has been cured and there is no evidence of recurrence of the disease within 5 years. But the cured basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ were excluded; 6. The patient is known to have central nervous system metastasis and / or cancerous meningitis; 7. The patient had severe hypersensitivity to another mAb treatment; 8. Patients with active autoimmune diseases (such as glucocorticoids or immunosuppressive drugs) that need systematic treatment in the past two years, and related alternative treatment (such as thyroxine, insulin, or physiological glucocorticoids with renal or pituitary dysfunction); patients with vitiligo, type I diabetes, childhood asthma / atopy, except for others; 9. Other serious and uncontrollable concomitant diseases that may affect the compliance of the program or interfere with the interpretation of the results, including active opportunistic infection or progressive (severe) infection, uncontrollable diabetes, cardiovascular disease (grade III or grade IV heart failure defined by the New York Heart Association classification, heart conduction block above grade II, myocardial infarction in the past 6 months, instability Sexual arrhythmia or unstable angina, cerebral infarction within 3 months, or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm); also including HIV positive; HCV positive; HBsAg or HBcAb positive at the same time detected positive copies of HBV DNA (quantitative detection limit is 500iu / ml); or have a clear history of tuberculosis; 10. Patients received live vaccine within 4 weeks before the first dose of treatment. Patients who had received hematopoietic stimulating factors (such as colony stimulating factor, erythropoietin, etc.) within 2 weeks before the start of the treatment; patients who had undergone major surgery (excluding diagnostic surgery) within 4 weeks before the start of the treatment; 11. Patients who are known to have mental or substance abuse disorders that may interfere with the requirements of the cooperative completion of the trial; 12. Pregnant or lactating women, or patients who plan to conceive or have children during the study period; 13. Other severe, acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results, according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recommended dose (RP2D) for phase II trial;incidence and severity of adverse events;objective tumor response rate (ORR);progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;clinical benefit rate;duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactChunying Li
Department of Dermatology, Xijing Hospital, Fourth Military Medical University (First Affiliated Hospital of the Air Force Medical University)
Outcome results
None listed