6 recruiting, 5 active not recruiting, 4 completed, 1 suspended. 17 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Recruiting 6, Active not recruiting 5, Completed 4, Suspended 1, Terminated 1 |
| Phase 2 | 3 | Active not recruiting 2, Recruiting 1 |
Follow cemiplimab: new trials by email Literature Review of cemiplimab trials Research Report on cemiplimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy Cemiplimab - Non-Small Cell Lung Cancer | Phase 3 | Recruiting | ETOP IBCSG Partners Foundation | 390 | 2026-01-12 | 2026-10-14 |
| A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC 6-Thio-2'-Deoxyguanosine, Cemiplimab, Docetaxel - Carcinoma, Non-Small -Cell Lung | Phase 3 | Recruiting | Maia Biotechnology | 300 | 2025-12-08 | 2026-01-12 |
| Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial) Biospecimen Collection, Cemiplimab, Computed Tomography - Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8 | Phase 2 / Phase 3 | Recruiting | SWOG Cancer Research Network | 378 | 2025-05-22 | 2026-10-09 |
| Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer Biospecimen Collection, Cemiplimab, Computed Tomography - Eyelid Squamous Cell Carcinoma, Recurrent Eyelid Squamous Cell Carcinoma | Phase 3 | Suspended | National Cancer Institute (NCI) | 420 | 2025-02-18 | 2026-10-20 |
| Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma Cemiplimab, Standard of care - Cutaneous Squamous Cell Carcinoma (CSCC) | Phase 3 | Recruiting | Regeneron Pharmaceuticals | 369 | 2025-01-02 | 2026-09-16 |
| A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) fianlimab, cemiplimab, relatlimab+nivolumab - Melanoma | Phase 3 | Recruiting | Regeneron Pharmaceuticals | 560 | 2024-09-09 | 2026-10-26 |
| A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer fianlimab, cemiplimab, Pemetrexed - Non-small Cell Lung Cancer | Phase 2 / Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 160 | 2023-08-08 | 2026-07-15 |
| A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) fianlimab, cemiplimab, Placebo - Advanced Non-Small Cell Lung Cancer | Phase 2 / Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 149 | 2023-06-30 | 2026-07-02 |
| A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery Fianlimab, Cemiplimab, Pembrolizumab - Melanoma | Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 1564 | 2023-01-16 | 2026-07-06 |
| Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets Blood Brain Barrier Opening - Oncology, Pembrolizumab, Atezolizumab - Brain Tumor, Non Small Cell Lung Cancer | Phase 3 | Recruiting | InSightec | 96 | 2022-08-12 | 2026-10-13 |
| Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Fianlimab, Cemiplimab, Pembrolizumab - Melanoma | Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 1546 | 2022-07-14 | 2026-04-22 |
| Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors Continue PD-1/PD-L1 Inhibitors treatment, Discontinue PD-1/PD-L1-1 inhibitor - Advanced Solid Tumors, NSCLC | Phase 3 | Completed | Dan Zandberg | 161 | 2019-11-15 | 2025-12-11 |
| Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Cemiplimab, Placebo - Cutaneous Squamous Cell Carcinoma | Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 415 | 2019-06-04 | 2026-03-27 |
| REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer REGN2810/ipi, REGN2810/chemo/ipi, Pembrolizumab - Non-small Cell Lung Cancer | Phase 3 | Terminated | Regeneron Pharmaceuticals | 5 | 2018-07-02 | 2022-11-16 |
| Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer REGN2810, REGN2810/chemo/ipi, Chemotherapy - Non-small Cell Lung Cancer | Phase 3 | Completed | Regeneron Pharmaceuticals | 789 | 2018-03-06 | 2026-05-18 |
| Study of Cemiplimab in Adults With Cervical Cancer Cemiplimab, Investigator Choice (IC) Chemotherapy - Squamous Cell Carcinoma (SCC), Recurrent or Metastatic, Platinum-refractory Cervical Cancer | Phase 3 | Completed | Regeneron Pharmaceuticals | 608 | 2017-09-05 | 2025-04-08 |
| Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Pemetrexed, Paclitaxel, Gemcitabine - Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell | Phase 3 | Completed | Regeneron Pharmaceuticals | 712 | 2017-05-29 | 2026-06-25 |
Carcinoma, Non-Small-Cell Lung (8) · Melanoma (4) · Carcinoma, Squamous Cell (2) · Lung Neoplasms (2) · Neoplasm Metastasis (2) · Skin Neoplasms (2) · Adenocarcinoma (1) · Anus Neoplasms (1) · Brain Neoplasms (1) · Carcinoma, Hepatocellular (1) · Carcinoma, Large Cell (1) · Carcinoma, Merkel Cell (1) · Cholangiocarcinoma (1) · Colorectal Neoplasms (1) · Kidney Neoplasms (1)
Regeneron Pharmaceuticals (11) · Dan Zandberg (1) · ETOP IBCSG Partners Foundation (1) · InSightec (1) · Maia Biotechnology (1) · National Cancer Institute (NCI) (1) · SWOG Cancer Research Network (1)
United States (14) · Australia (9) · Canada (9) · Italy (7) · Poland (7) · Spain (7) · Turkey (Türkiye) (7) · Georgia (6) · Brazil (5) · France (5) · Greece (5) · Ireland (5) · Romania (5) · South Korea (5) · Taiwan (5)
Dan Zandberg, MD (1) · Manmeet Ahluwalia, MD, MBA (1) · Neil D Gross (1) · Patrick Forde, MD, MBBCh, PhD (1) · Ross Soo, MB BS, PhD, FRACP (1) · Saiama N Waqar (1) · Victor Zaporojan, Medical Doctor (1)
PMID 33581821, PMID 35139273, PMID 35922251, PMID 36008722, PMID 36308296, PMID 37001859, PMID 37348996, PMID 37591293, PMID 38820979, PMID 40118215, PMID 40454639, PMID 40991883, PMID 41137728, PMID 41808570, PMID 41811823
2017 (3), 2016 (1), 2019 (1), 2023 (1), U10CA180868 (1), U10CA180888 (1)