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

NCT05789043 | Recruiting Phase 3

• 1 other identifier: MA-MM-III-004
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acral Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival, PFS

  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.

  Within 2 years

Secondary Outcomes (4)

• Overall Survival ,OS

  Within 2 years

• ORR

  Within 2 years

• DCR

  Within 2 years

• Adverse Events (AEs)

  Within 2 years

Study Arms (3)

Three-drug arm

EXPERIMENTAL

Drug: camrelizumab+apatinib+TMZ

Two-drug arm

ACTIVE COMPARATOR

Drug: camrelizumab+apatinib

single-drug arm

ACTIVE COMPARATOR

Drug: camrelizumab

Interventions

camrelizumab+apatinib+TMZ DRUG

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

Three-drug arm

camrelizumab+apatinib DRUG

camrelizumab 200mg，q2w+apatinib 250mg qd

Two-drug arm

camrelizumab DRUG

camrelizumab 200mg，q2w

single-drug arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

camrelizumab

Study Officials

• Jun Guo, Dr

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Guo, Dr

CONTACT

010-88121122; guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: March 21, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

CN (1)