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Recruiting

NCT Number: NCT05789043

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, China

Location status: Recruiting

Location contact

Jun Guo

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age:≥18 years, male or female.
  • Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (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 criteria

  • Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  • Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
  • Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia 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.

Treatment and study plan

camrelizumab+apatinib+TMZ

Drug

camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28

camrelizumab+apatinib

Drug

camrelizumab 200mg,q2w+apatinib 250mg qd

Camrelizumab

Drug

camrelizumab 200mg,q2w

Primary outcomes

  1. Progression Free Survival, PFS

    Time frame: Within 2 years

    PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Overall Survival ,OS

    Time frame: Within 2 years

    OS will be defined as the time from randomization to death due to any cause.

  2. ORR

    Time frame: Within 2 years

    The objective response rate will be assessed by RECIST 1.1

  3. DCR

    Time frame: Within 2 years

    The disease control rate will be assessed by RECIST 1.1

  4. Adverse Events (AEs)

    Time frame: Within 2 years

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Guo, Dr

CONTACT

[email protected]

010-88121122

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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