The Efficacy and Safety of Neoadjuvant Toripalimab Combined With Temozolomide in Resectable Stage III Melanoma

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to explore the efficacy and safety of neoadjuvant toripalimab combined with temozolomide in resectable stage III melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yong Chen
• Treatments: Temozolomide

Criteria

Inclusion Criteria:

• Has resectable stage IIIB-IIID melanoma of acral and cutaneous type, according to 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 of anti-PD-1 plus temozolomide. For patients with relapsed melanoma, previous therapy of anti-PD-1 plus temozolomide has been stopped for more than 6 months is acceptable.

For patients with disease progressed after receiving immune checkpoint inhibitors only, time from the last treating day is ≥ 4 weeks.

• 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:

• Has mucosal melanoma or choroidal 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.

• 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.