10 recruiting, 5 active not recruiting, 4 not yet recruiting, 1 suspended. 21 Phase 2, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 21 | Recruiting 10, Active not recruiting 5, Not yet recruiting 4, Suspended 1, Withdrawn 1 |
| Phase 3 | 2 | Active not recruiting 2 |
| Phase 1 | 1 | Active not recruiting 1 |
Follow Fianlimab: new trials by email Literature Review of Fianlimab trials Research Report on Fianlimab
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 Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck Cemiplimab, Fianlimab, Carboplatin - Squamous Cell Carcinoma | Phase 2 | Not yet recruiting | University of Chicago | 90 | 2027-02-07 | 2026-01-20 |
| Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma Fianlimab, Cemiplimab - Melanoma (Skin) | Phase 2 | Not yet recruiting | University of California, Irvine | 35 | 2026-12-01 | 2026-09-11 |
| A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC) Cemiplimab, Vidutolimod, Fianlimab - Locally Advanced Basal Cell Carcinoma | Phase 2 | Not yet recruiting | Regeneron Pharmaceuticals | 135 | 2026-11-13 | 2026-10-30 |
| PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma Cemiplimab, Lpilimumab, Fianlimab - Melanoma | Phase 2 | Not yet recruiting | M.D. Anderson Cancer Center | 20 | 2026-09-01 | 2026-04-06 |
| Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer Oxaliplatin, Capecitabine, Cemiplimab - Colorectal Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 66 | 2026-07-14 | 2026-07-21 |
| A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC) Fianlimab, Ipilimumab, Nivolumab - Advanced Renal Cell Carcinoma (aRCC), Metastatic Renal Cell Carcinoma ( mRCC) | Phase 2 | Recruiting | Brian Rini | 120 | 2026-04-29 | 2026-09-04 |
| Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma Cemiplimab, Fianlimab, Pemetrexed (Alimta) - Pleural Mesotheliomas | Phase 2 | Recruiting | Intergroupe Francophone de Cancerologie Thoracique | 126 | 2026-04-02 | 2026-08-11 |
| Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) Gemcitabine, Cisplatin, Cemiplimab - Bladder Cancer, Muscle-Invasive Bladder Carcinoma | Phase 2 | Recruiting | Columbia University | 36 | 2025-08-14 | 2025-09-02 |
| Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer Cemiplimab, Fianlimab, Radiotherapy - NSCLC, Locally Advanced | Phase 2 | Recruiting | Montefiore Medical Center | 76 | 2025-08-07 | 2026-04-13 |
| Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer Ubamatamab, Bevacizumab, Cemiplimab - Ovarian Cancer, Fallopian Tube Cancer | Phase 2 | Recruiting | Regeneron Pharmaceuticals | 297 | 2025-05-28 | 2026-09-14 |
| Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer Biospecimen Collection, Cemiplimab, Fianlimab - Lung Non-Small Cell Carcinoma, Stage IB Lung Cancer AJCC v8 | Phase 2 | Recruiting | Mayo Clinic | 60 | 2025-05-02 | 2026-10-29 |
| A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma Cemiplimab, Fianlimab - Renal Cell Carcinoma | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 10 | 2025-02-11 | 2026-03-04 |
| Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) cemiplimab, fianlimab - Cutaneous Squamous Cell Carcinoma | Phase 2 | Withdrawn | Regeneron Pharmaceuticals | 2024-11-14 | 2024-07-26 | |
| A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma Fianlimab, Cemiplimab, Ipilimumab - Advanced Melanoma | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 88 | 2024-09-10 | 2026-10-07 |
| A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery Fianlimab, Cemiplimab, Pemetrexed - Resectable Non-small Cell Lung Cancer | Phase 2 | Active not recruiting | Regeneron Pharmaceuticals | 195 | 2024-07-16 | 2026-08-10 |
| Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer Cemiplimab, Fianlimab - Colorectal Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 44 | 2024-06-13 | 2026-05-06 |
| 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 |
| Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery Cemiplimab, Computed Tomography, Biospecimen Collection - Locally Advanced Basal Cell Carcinoma, Basal Cell Carcinoma | Phase 2 | Suspended | Thomas Jefferson University | 70 | 2023-07-05 | 2026-06-10 |
| 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 |
| Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer Degarelix, pTVG-AR, Nivolumab - Prostate Cancer | Phase 1 / Phase 2 | Active not recruiting | University of Wisconsin, Madison | 57 | 2021-12-16 | 2026-09-30 |
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Carcinoma, Non-Small-Cell Lung (3) · Adenocarcinoma (2) · Carcinoma (2) · Carcinoma, Basal Cell (2) · Carcinoma, Renal Cell (2) · Colorectal Neoplasms (2) · Lung Neoplasms (2) · Melanoma (2) · Carcinoma, Hepatocellular (1) · Carcinoma, Squamous Cell (1) · Fallopian Tube Neoplasms (1) · Mesothelioma, Malignant (1) · Ovarian Neoplasms (1) · Prostatic Neoplasms (1) · Rectal Neoplasms (1)
Regeneron Pharmaceuticals (7) · Memorial Sloan Kettering Cancer Center (2) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (2) · Brian Rini (1) · Columbia University (1) · Intergroupe Francophone de Cancerologie Thoracique (1) · M.D. Anderson Cancer Center (1) · Mayo Clinic (1) · Montefiore Medical Center (1) · Thomas Jefferson University (1) · University of California, Irvine (1) · University of Chicago (1) · University of Wisconsin, Madison (1)
United States (18) · South Korea (4) · Taiwan (4) · Turkey (Türkiye) (4) · Australia (3) · Canada (3) · Georgia (3) · Malaysia (3) · France (2) · Israel (2) · Spain (2) · Thailand (2) · Chile (1) · Germany (1) · Italy (1)
Eric Christenson, MD (2) · Alexander Z Wei, MD (1) · Brian Rini, MD (1) · Douglas McNeel, MD (1) · James Smithy, MD (1) · Joseph Curry, MD (1) · Kaushal Parikh, MBBS (1) · Martin Voss, MD (1) · Nitin Ohri, MD, MS (1) · Rodabe N Amaria, MD (1) · Valerie Lee, MD (1)
PMID 35065058, PMID 39437804, PMID 41781018
2023 (2), P50CA269011 (1)