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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05789043
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking University Cancer Hospital & Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jun Guo, Dr
Principal Investigator Affiliation	Peking University Cancer Hospital & Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acral Melanoma

Arms & Interventions

Arms

Experimental: Three-drug arm

Active Comparator: Two-drug arm

Active Comparator: single-drug arm

Interventions

Drug: - camrelizumab+apatinib+TMZ

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

Drug: - camrelizumab+apatinib

camrelizumab 200mg，q2w+apatinib 250mg qd

Drug: - camrelizumab

camrelizumab 200mg，q2w

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, ,

Site Contact

Jun Guo

[email protected]

010-88121122

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