Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

Last updated: September 4, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Melanoma

Treatment

camrelizumab

camrelizumab+apatinib+TMZ

camrelizumab+apatinib

Clinical Study ID

NCT05789043
MA-MM-III-004
  • Ages > 18
  • All Genders

Study Summary

It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age:≥18 years, male or female.
  • Histopathologically confirmed recurrence, inoperable resection or metastatic acralmelanoma (stage III/IV).
  • Has not received any systematic anti-tumor drug treatment.
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • ECOG 0-1.
  • Adequate organ function.
  • Life expectancy of greater than 12 weeks.
  • Patient has given written informed consent.

Exclusion

Exclusion Criteria:

  • Patients who have or are currently undergoing additional chemotherapy, radiationtherapy, targeted therapy or immunotherapy.
  • Known history of hypersensitivity to macromolecular protein preparation or anycomponents of the drug formulation.
  • Subjects before or at the same time with other malignant tumors (except which hascured skin basal cell carcinoma and cervical carcinoma in situ);
  • Subjects with any active autoimmune disease or history of autoimmune diseaseUncontrolled clinically significant heart disease, including but not limited to thefollowing: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardialinfarction within the past 1 year; (4) clinically significant supraventriculararrhythmia or ventricular arrhythmia requirement for treatment or intervention;
  • Received a live vaccine within 4 weeks before the first dose of study medication.
  • Pregnancy or breast feeding.
  • Decision of unsuitableness by principal investigator or physician-in charge.

Study Design

Total Participants: 140
Treatment Group(s): 3
Primary Treatment: camrelizumab
Phase: 3
Study Start date:
March 21, 2023
Estimated Completion Date:
February 15, 2027

Connect with a study center

  • Beijing Cancer Hospital

    Beijing,
    China

    Active - Recruiting

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