Trial reportJournal for immunotherapy of cancer2022
Toripalimab plus axitinib in patients with metastatic mucosal melanoma: 3-year survival update and biomarker analysis.
Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03086174 (A Phase Ib,Open,Mono-center,Dose-escalation,Tolerability and Pharmacokinetic Study of Recombinant Humanized Anti-PD-1 mAb for Injection in Combination With Axitinib in Patients With Advanced Kidney Cancer and Melanoma), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase Ib,Open,Mono-center,Dose-escalation,Tolerability and Pharmacokinetic Study of Recombinant Humanized Anti-PD-1 mAb for Injection in Combination With Axitinib in Patients With Advanced Kidney Cancer and Melanoma
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative efficacy and safety of first-line neoadjuvant therapy for early-stage non-small cell lung cancer based on immune checkpoint inhibitor therapy: a systematic review and network meta-analysis.BMC pulmonary medicine · 2025Pooled it
- A phase II peri-operative study of pembrolizumab plus lenvatinib for mucosal melanoma.Nature communications · 2026Trial
- Real-world study of SHR-1210 plus apatinib in the treatment of BRAF-negative mucosal melanoma: efficacy, safety and implications of precision medicine.Frontiers in immunology · 2026Trial
- Toripalimab combined with bevacizumab plus chemotherapy as first-line treatment for refractory recurrent or metastatic cervical cancer: a single-arm, open-label, phase II study (JS001-ISS-CO214).Journal of gynecologic oncology · 2025Trial
- Atezolizumab plus bevacizumab in patients with unresectable or metastatic mucosal melanoma: 3-year survival update and multi-omics analysis.Clinical and translational medicine · 2025Trial
- Single-arm study of camrelizumab plus apatinib for patients with advanced mucosal melanoma.Journal for immunotherapy of cancer · 2024Trial
- Efficacy and safety of anti-PD-1-based therapies in advanced melanoma across acral and mucosal subtypes: a nationwide retrospective cohort study.Cancer immunology, immunotherapy : CII · 2026Article
- Advanced Mucosal Melanoma Therapies: Current Status and Future Directions.Current treatment options in oncology · 2026Review
- Navigating Immunotherapy Resistance: The Role of Cross-Line Strategies in Cancer Treatment.Journal of clinical medicine · 2026Article
- Stable Disease Achieved with Sequential Immunochemotherapy and Anti-Angiogenic TKI in Recurrent Metastatic Hidradenocarcinoma: A Case Report and Literature Review.Oncology research · 2026Review
- Clinical significance and functional characterization of RRN3 in gastric cancer: insights from pan-cancer analysis and experimental validation.Frontiers in oncology · 2026Article
- Mucosal Melanoma: An Overview of Recent Therapies.Current pharmaceutical design · 2026Review
- Review
- Combination Immunotherapy for Mucosal Melanoma: Molecular Mechanism, Research Status, and Future Directions.Current treatment options in oncology · 2025Review
- Dynamic Change of PD-L2 on Circulating Plasma Extracellular Vesicles as a Predictor of Treatment Response in Melanoma Patients Receiving Anti-PD-1 Therapy.Journal of extracellular vesicles · 2025Article
- A Fatal Case of Metastatic Primary Gastric Melanoma: Diagnostic Challenges and Therapeutic Dilemmas.Cancer management and research · 2025Article
- Melanoma-derived extracellular vesicles transfer proangiogenic factors.Oncology research · 2025Review
- Effectiveness of immune checkpoint inhibitors and other treatment modalities in patients with advanced mucosal melanomas: a systematic review and individual patient data meta-analysis.EClinicalMedicine · 2024Article
- Efficacy of axitinib in a US cohort of patients with programmed cell death protein 1-resistant mucosal melanoma.Melanoma research · 2024Article
- Impact of Treatment Delay in Head and Neck Mucosal Melanoma on Overall Patient Survival.Journal of neurological surgery. Part B, Skull base · 2024Article
Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMucosal melanoma is an aggressive melanoma subtype with poor response to antiprogrammed cell death-1 (PD-1) monotherapy. Axitinib in combination with toripalimab, a humanized IgG4 mAb against PD-1, showed a promising response rate in patients with metastatic mucosal melanoma (MM) in a phase Ib study. Here, we report the updated overall survival (OS), duration of response (DoR), and biomarker analysis results.
methodsPatients with advanced MM received toripalimab 1 or 3 mg/kg intravenously every 2 weeks combined with axitinib 5 mg orally two times per day until disease progression or unacceptable toxicity. Tumor programmed cell death ligand-1 (PD-L1) expression, tumor mutational burden (TMB), and gene expression profile (GEP) by messenger RNA sequencing were evaluated for correlation with survival.
resultsAs of April 2, 2021, the median follow-up was 42.5 months. Among 29 chemotherapy-naïve patients with metastatic MM, the median OS was 20.7 months (95% CI 9.7 to 32.7 months); the median progression-free survival (PFS) was 7.5 months (95% CI 3.8 to 14.8 months); and the median DoR was 13.4 months (95% CI 5.5 to 20.6 months). The OS rates of 1, 2, and 3 years were 62.1%, 44.8%, and 31.0%, respectively. Biomarker analysis found that PD-L1 expression and TMB level were not associated with survival benefits. In contrast, a 12-GEP signature correlated with improved PFS (17.7 vs 5.7 months, p=0.0083) and OS (35.6 vs 17.6 months, p=0.039).
conclusionsThe 3-year survival update confirmed the antitumor activity and long-term survival benefit of the toripalimab plus axitinib combination in patients with advanced MM. The 12-gene GEP is of value in predicting the outcomes of vascular endothelial growth factor receptor-tyrosine kinase inhibitor and PD-1 blockade combination therapy, but requires further validation. TRIAL REGISTRATION NUMBERS: NCT03086174.
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