Trial reportCancer immunology, immunotherapy : CII2019
Early objective response to avelumab treatment is associated with improved overall survival in patients with metastatic Merkel cell carcinoma.
Trial report in Cancer immunology, immunotherapy : CII, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02155647 (A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab), which is not on this map. Cited by 14 papers.
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 II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma
Who cites it
14 citing papers in PubMed.
- Neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma: an investigator-initiated, open-label phase II trial.Journal for immunotherapy of cancer · 2026Trial
- Trial
- Survival Analysis in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab.Advances in therapy · 2019Trial
- Access to systemic treatment of non-melanoma skin cancer in Spain: a survey analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer.Journal for immunotherapy of cancer · 2022Article
- Response durability after cessation of immune checkpoint inhibitors in patients with metastatic Merkel cell carcinoma: a retrospective multicenter DeCOG study.Cancer immunology, immunotherapy : CII · 2021Article
- Clinical benefit of baseline imaging in Merkel cell carcinoma: Analysis of 584 patients.Journal of the American Academy of Dermatology · 2021Article
- Merkel Cell Carcinoma: Evaluation of the Clinico-Pathological Characteristics, Treatment Strategies and Prognostic Factors in a Monocentric Retrospective Series (n=143).Frontiers in oncology · 2021Article
- Avelumab as second-line therapy for metastatic, platinum-treated urothelial carcinoma in the phase Ib JAVELIN Solid Tumor study: 2-year updated efficacy and safety analysis.Journal for immunotherapy of cancer · 2020Article
- Avelumab for advanced Merkel cell carcinoma in the Netherlands: a real-world cohort.Journal for immunotherapy of cancer · 2020Article
- Avelumab as an Emerging Therapy for Eyelid and Periocular Merkel Cell Carcinoma.International ophthalmology clinics · 2020Article
- Driving innovation for rare skin cancers: utilizing common tumours and machine learning to predict immune checkpoint inhibitor response.Immuno-oncology technology · 2019Review
- Review
- [Immune checkpoint inhibition in Merkel cell carcinoma].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2019Review
Corrections and comments
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Authors and funding
17 authors.
Funding
Abstract
backgroundResponse rates are primary endpoints in many oncology trials; however, correlation with overall survival (OS) is not uniform across cancer types, treatments, or lines of therapy. This study explored the association between objective response (OR) and OS in patients with chemotherapy-refractory metastatic Merkel cell carcinoma who received avelumab (anti-PD-L1).
methodsEighty-eight patients enrolled in JAVELIN Merkel 200 (part A; NCT02155647) received i.v. avelumab 10 mg/kg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal. Using conditional landmark analyses, we compared OS in patients with and without confirmed OR (RECIST v1.1). We applied a Cox model that included OR as a time-varying covariate and adjusted for age, visceral disease, and number of previous therapies.
resultsTwenty-nine patients had confirmed OR; 20 by study week 7 and 7 more between study weeks 7 and 13. Survival probabilities 18 months after treatment initiation were 90% [95% confidence interval (CI) 65.6-97.4] in patients with OR at week 7 and 26.2% (95% CI 15.7-37.8) in patients without OR but who were alive at week 7. Median OS was not reached in patients with OR and was 8.8 months (95% CI 6.4-12.9) in patients without. Similar results were observed for the week 13 landmark. The adjusted Cox model showed OR was associated with a 95% risk reduction of death [hazard ratio 0.052 (95% CI 0.018-0.152)] compared with a nonresponse.
conclusionsPatients with OR by 7 or 13 weeks had significantly longer OS than patients without, confirming that early OR is an endpoint of major importance.
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Registered trials
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.