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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05789043
Other study ID # MA-MM-III-004
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 21, 2023
Est. completion date February 15, 2027

Study information

Verified date September 2023
Source Peking University Cancer Hospital & Institute
Contact Jun Guo, Dr
Phone 010-88121122
Email guoj307@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date February 15, 2027
Est. primary completion date August 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Beijing Cancer Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Survival ,OS OS will be defined as the time from randomization to death due to any cause. Within 2 years
Secondary ORR The objective response rate will be assessed by RECIST 1.1 Within 2 years
Secondary DCR The disease control rate will be assessed by RECIST 1.1 Within 2 years
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05512481 - Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma Phase 2
Recruiting NCT04119024 - Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors Phase 1
Recruiting NCT05628883 - Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma Phase 1
Recruiting NCT04331093 - Neoadjuvant SHR-1210 Plus Apatinib for Resectable Stage III-IV Acral Melanoma Phase 2
Not yet recruiting NCT05436990 - Antitumor Activity of Vactosertib in Combination With Pembrolizumab in Acral and Mucosal Melanoma Patients Progressed From Prior Immune Check Point Inhibitor Phase 2
Completed NCT00788775 - Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma Phase 2
Recruiting NCT05086692 - A Beta-only IL-2 ImmunoTherapY Study Phase 1/Phase 2