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

Launched by YONG CHEN · Apr 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two treatments, toripalimab and temozolomide, to see how well they work and how safe they are for patients with resectable stage III melanoma. Melanoma is a type of skin cancer, and in this trial, researchers want to find out if giving these treatments before surgery can help improve outcomes for patients. The trial is not yet recruiting participants, but it aims to include adults aged 18 and older who meet specific health criteria.

To be eligible, participants must have a certain type of melanoma that can be surgically removed and should not have received specific prior treatments. They should also have a good level of health, with manageable side effects from any past treatments and a good chance of surviving for at least 12 weeks. Women of childbearing age will need to take a pregnancy test before starting the study, and both men and women must agree to use effective contraception during the trial. If you’re interested in learning more about this trial, it's important to check with your doctor to see if you qualify and to discuss any questions you may have.

Gender

ALL

Eligibility 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.