to explore the efficacy and safety of shr-1701 combined with temozolomide in the treatment of advanced melanoma

Conditions: Melanoma

Summary: this study is being conducted to explore the efficacy and safety of shr-1701 combined with temozolomide in the treatment of advanced melanoma.

this trial is a prospective, single-center, single-arm clinical research. based on current experience, single agent immunotherapy has limited efficacy in advanced melanoma. shr-1701 is a novel immunotherapy drug . preclinical data suggest that temozolomide selectively depletes regulatory t cells. this potential immunomodulatory effect of temozolomide provides rationale for combination with shr-1701. this study is aiming to evaluate the efficacy and safety of shr-1701 combined with temozolomide in patients with advanced melanoma. the safety and efficacy of this study will be assessed through orr, dcr,pfs, os , and adverse effects as graded by ctcae 5.0.

Eligibility criteria:
inclusion criteria: * has unresectable stage iii or stage iv or melanoma per american joint committee on cancer (ajcc) staging system version 8. at least one measurable lesion conforming to recist 1.1 criteria. * no previously received systematic therapy. * the toxicity of prior treatment has recovered to ≤1 grade according to ctcae 5.0. * ecog score 0-1. * the expected survival time is ≥ 12 weeks. * adequate organ and bone marrow function. * female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; for male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study. * willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures. exclusion criteria: * history of other malignant tumors, except for cured skin basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder carcinoma, papillary thyroid carcinoma, intraductal carcinoma and cervical carcinoma in situ. * has ocular melanoma. * the first study drug treatment was less than 4 weeks from the last systematic antitumor therapy or 5 half-lives from the last targeted therapy; less than 4 weeks from major surgery; less than7 days from immunosuppressive drug; less than 3 weeks from immunomodulatory; less than 4 weeks from live attenuated vaccine. * systemic antibiotic use for 7 days within 4 weeks prior to initial administration, or unexplained fever during screening/prior to initial administration. * with active autoimmune disease or a history of autoimmune disease. * with history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * with immunodeficiency, eg hiv, hbv, hcv. * have a clear history of serious and uncontrolled other disease or mental disorders. * has a bleeding tendency or abnormal clotting function. * subjects with central nervous system disease or brain metastases. * known to be allergic to the active ingredients or excipients in this study. * other situations that the researcher considers inappropriate to participate in the research.