Related Experiment Video
Updated: Jul 28, 2025
A Melanoma Patient-Derived Xenograft Model
Published on: May 20, 2019
Camrelizumab Plus Apatinib and Temozolomide as First-Line Treatment in Patients With Advanced Acral Melanoma: The CAP
Lili Mao1, Bin Lian1, Caili Li1
1Department of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China.
Importance:
Acral melanoma, known for low tumor mutation burden, responds poorly to immunotherapy. A standard therapy is still lacking.
Objective:
To investigate the activity and safety of camrelizumab (an anti-programmed cell death-1 antibody) plus apatinib (a vascular endothelial growth factor receptor 2 inhibitor) and temozolomide as first-line treatment in patients with advanced acral melanoma.
Design, Setting, And Participants:
In this single-arm, single-center, phase 2 nonrandomized clinical trial, patients with treatment-naive unresectable stage III or IV acral melanoma were enrolled at Peking University Cancer Hospital and Institute between June 4, 2020, and August 24, 2021. The data cutoff date was April 10, 2022.
Interventions:
Patients received 4-week cycles of intravenous camrelizumab, 200 mg, every 2 weeks; oral apatinib 250 mg, once daily; and intravenous temozolomide, 200 mg/m2, once daily on days 1 to 5 until disease progression or unacceptable toxic effects.
Main Outcomes And Measures:
The primary end point was objective response rate as assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (version 1.1). Secondary end points included progression-free survival, time to response, duration of response, disease control rate, overall survival, and safety.
Results:
A total of 50 patients (32 men [64%]; median age, 57 years [IQR, 52-62 years]) were enrolled and received treatment. The median follow-up duration was 13.4 months (IQR, 9.6-16.2 months). The objective response rate was 64.0% (32 of 50; 95% CI, 49.2%-77.1%). The median time to response and duration of response were 2.7 months (IQR, 0.9-2.9 months) and 17.5 months (95% CI, 12.0 to not reached), respectively. The disease control rate was 88.0% (44 of 50; 95% CI, 75.7%-95.5%). The estimated median progression-free survival was 18.4 months (95% CI, 10.6 to not reached). The median overall survival was not reached. The most common grade 3 or 4 treatment-related adverse events were increased gamma-glutamyltransferase levels (15 [30%]), decreased neutrophil count (11 [22%]), increased conjugated bilirubin levels (10 [20%]), and increased aspartate aminotransferase levels (10 [20%]). No treatment-related deaths occurred.
Conclusions And Relevance:
The findings of this nonrandomized clinical trial suggest that camrelizumab plus apatinib and temozolomide may be a potential first-line treatment option for patients with advanced acral melanoma, which warrants further validation in a randomized clinical trial.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04397770.
Insights
This study suggests camrelizumab, apatinib, and temozolomide show promise as a first-line treatment for advanced acral melanoma, offering a potential new option for patients with this rare cancer.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Acral melanoma has a low tumor mutation burden and poor response to immunotherapy.
- Standard first-line therapy for advanced acral melanoma is lacking.
Purpose of the Study:
- To evaluate the efficacy and safety of camrelizumab (anti-PD-1 antibody) combined with apatinib (VEGFR2 inhibitor) and temozolomide as first-line treatment for advanced acral melanoma.
Main Methods:
- A single-arm, phase 2 nonrandomized clinical trial involving 50 treatment-naive patients with unresectable stage III or IV acral melanoma.
- Patients received camrelizumab, apatinib, and temozolomide in 4-week cycles until disease progression or toxicity.
Main Results:
- The objective response rate was 64.0%, with a median progression-free survival of 18.4 months.
- The disease control rate was 88.0%. Common grade 3/4 adverse events included elevated liver enzymes and neutropenia.
- No treatment-related deaths were reported.
Conclusions:
- Camrelizumab plus apatinib and temozolomide demonstrates potential as a first-line treatment for advanced acral melanoma.
- Further validation in a randomized clinical trial is warranted.
Related Concept Videos
02:56Treatment Resistant Cancers
01:27Tumor Immunotherapy
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...
02:50Combination Therapies and Personalized Medicine
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...