Trial reportJournal for immunotherapy of cancer2020
Phase 2 study of cemiplimab in patients with metastatic cutaneous squamous cell carcinoma: primary analysis of fixed-dosing, long-term outcome of weight-based dosing.
Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 98 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Who cites it
98 citing papers in PubMed, 2 syntheses or guidelines pooled it, 172 citations in OpenAlex.
- Immune checkpoint inhibitors in advanced cutaneous squamous cell carcinoma: A systemic review and meta-analysis.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2023Pooled it
- Immune Checkpoint Inhibitors for Advanced Cutaneous Squamous Cell Carcinoma: A Systematic Review with Meta-Analysis.Targeted oncology · 2021Pooled it
- Neoadjuvant ipilimumab and nivolumab in resectable cutaneous squamous cell carcinoma: a randomized phase 2 trial.Nature medicine · 2025Trial
- CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma.Future oncology (London, England) · 2025Trial
- High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma.Journal for immunotherapy of cancer · 2024Trial
- Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis.Journal for immunotherapy of cancer · 2021Trial
- Lethal medical course of an untreated giant cutaneous squamous cell carcinoma.Forensic science, medicine, and pathology · 2026Article
- Recent highlights and breakthroughs in immunotherapy for head and neck cancers.Current opinion in oncology · 2026Review
- Second-line treatments for patients with programmed cell death protein 1-refractory cutaneous squamous cell carcinomas: a brief report.The oncologist · 2026Article
- A Treatment Decision Model for Cutaneous Squamous Cell Carcinoma Based on Bayesian Networks.Cancers · 2026Article
- Concurrent Nasal Sebaceous Carcinoma and Right-Hand Squamous Cell Carcinoma: A Case Report and Literature Review.Clinical, cosmetic and investigational dermatology · 2026Article
- Advances in Targeted and Immunotherapy for High-Risk Cutaneous Malignancies.Oncology research · 2026Review
- Advanced Cutaneous Squamous Cell Carcinoma: Biology, Immunotherapy, and Evolving Prognostic Factors.Biomedicines · 2025Review
- Checkpoint Inhibitors and Beyond: A Systematic Review of Immunotherapy in Cutaneous Malignancies.Cureus · 2025Review
- Immune checkpoint inhibitors for the treatment of solid tumors and lymphoma in the past 26 years (2000-2025).Journal of hematology & oncology · 2025Review
- Cosibelimab: A Novel Therapeutic for Advanced Cutaneous Squamous Cell Carcinoma.The Journal of clinical and aesthetic dermatology · 2025Review
- Identification of prognostic liquid biopsy biomarkers in patients with cutaneous squamous cell carcinoma treated with cemiplimab.Journal of translational medicine · 2025Article
- Managing Advanced Squamous Cell Carcinoma: A Guide for the Dermatology Clinician.The Journal of clinical and aesthetic dermatology · 2025Review
- Immune Checkpoint Inhibitors in the Treatment of Ocular Surface Cancers: A Review.Seminars in ophthalmology · 2025Review
- Recommendations for the management of cutaneous squamous cell carcinoma: a systematic multidisciplinary Delphi consensus approach.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
38 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 20 institutions in 3 countries.
Funding
Abstract
backgroundCemiplimab, a high-affinity, potent human immunoglobulin G4 monoclonal antibody to programmed cell death-1 demonstrated antitumor activity in a Phase 1 advanced cutaneous squamous cell carcinoma (CSCC) expansion cohort (NCT02383212) and the pivotal Phase 2 study (NCT02760498). Here we report the primary analysis of fixed dose cemiplimab 350 mg intravenously every 3 weeks (Q3W) (Group 3) and provide a longer-term update after the primary analysis of weight-based cemiplimab 3 mg/kg intravenously every 2 weeks (Q2W) (Group 1) among metastatic CSCC (mCSCC) patients in the pivotal study (NCT02760498).
methodsThe primary objective for each group was objective response rate (ORR) per independent central review (ICR). Secondary endpoints included ORR by investigator review (INV), duration of response (DOR) per ICR and INV, and safety and tolerability.
resultsFor Group 3 (n=56) and Group 1 (n=59), median follow-up was 8.1 (range, 0.6 to 14.1) and 16.5 (range, 1.1 to 26.6) months, respectively. ORR per ICR was 41.1% (95% CI, 28.1% to 55.0%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 45.2% (95% CI, 35.9% to 54.8%) in both groups combined. Per ICR, Kaplan-Meier estimate for DOR at 8 months was 95.0% (95% CI, 69.5% to 99. 3%) in responding patients in Group 3, and at 12 months was 88.9% (95% CI, 69.3% to 96.3%) in responding patients in Group 1. Per INV, ORR was 51.8% (95% CI, 38.0% to 65.3%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 50.4% (95% CI, 41.0% to 59.9%) in both groups combined. Overall, the most common adverse events regardless of attribution were fatigue (27.0%) and diarrhea (23.5%).
conclusionIn patients with mCSCC, cemiplimab 350 mg intravenously Q3W produced substantial antitumor activity with durable response and an acceptable safety profile. Follow-up data of cemiplimab 3 mg/kg intravenously Q2W demonstrate ongoing durability of responses. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, NCT02760498. Registered May 3, 2016, https://clinicaltrials.gov/ct2/show/NCT02760498.
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What OpenQuestion holds
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.