Clinical trial · Interventional
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
NCT05789043CI-TRIAL-00069364recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acral Melanoma | Acral Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| camrelizumab | Drug | Camrelizumab | ALIAS |
| camrelizumab+apatinib | Drug | — | UNRESOLVED |
| camrelizumab+apatinib+TMZ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Three-drug arm
- interventionNames
- Drug: camrelizumab+apatinib+TMZ
- type
- ACTIVE_COMPARATOR
- label
- Two-drug arm
- interventionNames
- Drug: camrelizumab+apatinib
- type
- ACTIVE_COMPARATOR
- label
- single-drug arm
- interventionNames
- Drug: camrelizumab
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.