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

NCT05827770 | Unknown Phase 2

• 1 other identifier: FU-Name-T004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma Stage III

Outcome Measures

Primary Outcomes (1)

• Pathologic response rate (pRR)

  After 2 cycles of neoadjuvant toripalimab combined with temozolomide, patients receive radical surgery.

  Within one week after operation

Study Arms (1)

Toripalimab Combined With Temozolomide

EXPERIMENTAL

Toripalimab Combined With Temozolomide

Drug: Toripalimab combined with Temozolomide

Interventions

Toripalimab combined with Temozolomide DRUG

Toripalimab combined with Temozolomide

Toripalimab Combined With Temozolomide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yong Chen: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yong Chen, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Chen, MD

CONTACT

18017317571; chenyong@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 25, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)