Trial reportJournal for immunotherapy of cancer2025
Pretreatment and on-treatment ctDNA and tissue biomarkers predict recurrence in patients with stage IIIB-D/IV melanoma treated with adjuvant immunotherapy: CheckMate 915.
Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03068455 (A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma), which is not on this map. Cited by 15 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 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Five-year survival with neoadjuvant therapy in melanoma: updated pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC).Nature medicine · 2026Article
- Pre-operative circulating tumour DNA in high-risk primary cutaneous melanoma: prospective feasibility in molecular pathology.Acta oncologica (Stockholm, Sweden) · 2026Article
- Circulating Tumor DNA as a Biomarker for Melanoma Prognosis and Therapy.American journal of clinical dermatology · 2026Review
- Durable benefits, but no improvements in overall survival: what can we learn from CheckMate 238 after 9 years of follow-up?Translational cancer research · 2026Article
- Cancer drug response and resistance: molecular mechanisms and combating strategies.Signal transduction and targeted therapy · 2026Review
- Peripheral blood IFN-γ-producing T-cell subsets and soluble IL-2 receptor as independent prognostic biomarkers in NSCLC treated with immune checkpoint inhibitor-based therapy.Discover oncology · 2026Article
- Reconsidering adjuvant and perioperative immune-checkpoint inhibition: de-escalation, expansion and personalization.Nature reviews. Clinical oncology · 2026Review
- Advances in the treatment of cutaneous tumors: from conventional therapies to targeted and immunotherapeutic strategies.World journal of surgical oncology · 2026Review
- Review
- After a Decade of Therapy Revolution in Cutaneous Melanoma-Perspectives on Emerging Treatment Strategies.Oncology research · 2026Review
- Tumor-infiltrating immune cell types predicting recurrence-free survival in melanoma patients receiving adjuvant PD-1 inhibitor therapy.Frontiers in immunology · 2026Article
- Personalized Circulating Tumor DNA Assay to Assess Long-Term Clinical Benefit in Patients with Advanced Melanoma.Cancers · 2025Article
- Bespoke ctDNA for longitudinal detection of molecular residual disease in high-risk melanoma patients.ESMO open · 2024Article
- Rapidly Evolving Pre- and Post-surgical Systemic Treatment of Melanoma.American journal of clinical dermatology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCheckMate 915 (NCT03068455) compared adjuvant nivolumab monotherapy versus combination nivolumab+ipilimumab in patients with resected stage III/IV melanoma. This exploratory analysis was performed to identify biomarkers that correlate with benefit from adjuvant immunotherapy. PATIENTS AND
methods1,844 patients received nivolumab 480 mg every 4 weeks or nivolumab 240 mg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks. Tumor and peripheral biomarkers were evaluated, including tumor-informed circulating tumor DNA (ctDNA) at postresection baseline and on-treatment, for their association with recurrence-free survival and distant metastases-free survival.
resultsBiomarker analyses were conducted in 60-96% of the intention-to-treat population. ctDNA positivity at baseline (seen in 16.2% of patients) and on-treatment was associated with higher risk of recurrence than ctDNA negativity (HR, 1.97; 95% CI, 1.57 to 2.46), with a high specificity (87%) and modest sensitivity (39%). ctDNA status, tumor mutational burden (TMB) status (TMB < or ≥350 mutations/tumor) and interferon gamma-RNA signature score (< or ≥median) evaluated together, as well as ctDNA status with tumor CD8 or cell programmed death ligand 1 expression, were more predictive of survival than ctDNA alone. Tumor bulk RNA-seq expression patterns identified gene expression at baseline associated with recurrence.
conclusionsThis study represents the largest assessment of ctDNA and other baseline tumor and peripheral biomarkers for predicting recurrence-free survival in patients with resected melanoma receiving adjuvant immunotherapy. ctDNA alone and in combination with more established biomarkers predicted recurrence-free and distant metastasis-free survival and has potential utility for assessing and monitoring the risk of recurrence in patients with resected melanoma treated with immunotherapy in the adjuvant setting. TRIAL REGISTRATION NUMBER: NCT03068455.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.