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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acral Melanoma
• Intervention / Treatment: Drug: camrelizumab+apatinib+TMZ; Drug: camrelizumab+apatinib; Drug: camrelizumab

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jun Guo, Dr; Phone Number: 010-88121122; Email: guoj307@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Jun Guo; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three-drug arm	Drug: camrelizumab+apatinib+TMZ; camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
Active Comparator: Two-drug arm	Drug: camrelizumab+apatinib; camrelizumab 200mg，q2w+apatinib 250mg qd
Active Comparator: single-drug arm	Drug: camrelizumab; camrelizumab 200mg，q2w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival ,OS	OS will be defined as the time from randomization to death due to any cause.	Within 2 years
ORR	The objective response rate will be assessed by RECIST 1.1	Within 2 years
DCR	The disease control rate will be assessed by RECIST 1.1	Within 2 years
Adverse Events (AEs)	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.	Within 2 years

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Investigators: Principal Investigator: Jun Guo, Dr, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: MA-MM-III-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No