Related Experiment Video
Updated: Jun 23, 2025
A Melanoma Patient-Derived Xenograft Model
Published on: May 20, 2019
Single-arm study of camrelizumab plus apatinib for patients with advanced mucosal melanoma
Lianjun Zhao1,2, Yu Ren1,2, Guiying Zhang3
1The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Background:
Previous studies have suggested the potential synergistic antitumor activity when combining immune checkpoint inhibitors with anti-angiogenic agents in various solid tumors. We aimed to assess the efficacy and safety of camrelizumab (a humanized programmed cell death-1 antibody) plus apatinib (a vascular endothelial growth factor receptor tyrosine kinase inhibitor) for patients with advanced mucosal melanoma (MM), and explore-related biomarkers.
Methods:
We conducted a single-center, open-label, single-arm, phase II study. Patients with unresectable or recurrent/metastatic MM received camrelizumab and apatinib. The primary endpoint was the confirmed objective response rate (ORR).
Results:
Between April 2019 and June 2022, 32 patients were enrolled, with 50.0% previously received systemic therapy. Among 28 patients with evaluable response, the confirmed ORR was 42.9%, the disease control rate was 82.1%, and the median progression-free survival (PFS) was 8.05 months. The confirmed ORR was 42.9% (6/14) in both treatment-naïve and previously treated patients. Notably, treatment-naïve patients had a median PFS of 11.89 months, and those with prior treatment had a median PFS of 6.47 months. Grade 3 treatment-related adverse events were transaminase elevation, rash, hyperbilirubinemia, proteinuria, hypertension, thrombocytopenia, hand-foot syndrome and diarrhea. No treatment-related deaths were observed. Higher tumor mutation burden (TMB), increased T-cell receptor (TCR) diversity, and altered receptor tyrosine kinase (RTK)/RAS pathway correlated with better tumor response.
Conclusion:
Camrelizumab plus apatinib provided promising antitumor activity with acceptable toxicity in patients with advanced MM. TMB, TCR diversity and RTK/RAS pathway genes were identified as potential predictive biomarkers and warrant further validation.
Trial Registration Number:
Chinese Clinical Trial Registry, ChiCTR1900023277.
Insights
Camrelizumab plus apatinib showed significant antitumor activity in advanced mucosal melanoma patients, with an objective response rate of 42.9%. Biomarkers like tumor mutation burden and TCR diversity may predict treatment success.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacology
Background:
- Previous studies suggest combining immune checkpoint inhibitors with anti-angiogenic agents can yield synergistic antitumor effects.
- Advanced mucosal melanoma (MM) presents a therapeutic challenge, necessitating novel treatment strategies.
Purpose of the Study:
- To evaluate the efficacy and safety of camrelizumab, a programmed cell death-1 antibody, combined with apatinib, a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in advanced MM.
- To identify potential predictive biomarkers for this combination therapy.
Main Methods:
- A single-center, open-label, single-arm, phase II clinical trial was conducted.
- 32 patients with unresectable or recurrent/metastatic MM received camrelizumab and apatinib.
- The primary endpoint was the confirmed objective response rate (ORR).
Main Results:
- The confirmed ORR was 42.9% among 28 evaluable patients, with a disease control rate of 82.1%.
- Median progression-free survival (PFS) was 8.05 months; treatment-naïve patients had a longer median PFS (11.89 months) than those with prior treatment (6.47 months).
- Higher tumor mutation burden (TMB), increased T-cell receptor (TCR) diversity, and altered receptor tyrosine kinase (RTK)/RAS pathway were associated with better response. Grade 3 adverse events were manageable, with no treatment-related deaths.
Conclusions:
- Camrelizumab plus apatinib demonstrated promising antitumor activity and acceptable toxicity in advanced MM.
- TMB, TCR diversity, and RTK/RAS pathway genes are potential predictive biomarkers requiring further validation.
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