^
    1d
    R3767-ONC-2208: A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma (clinicaltrials.gov)
    P2, N=151, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: Apr 2031 --> Dec 2030 | Trial primary completion date: Mar 2027 --> Nov 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    16d
    CLeAR: Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Virginia Commonwealth University
    New P1 trial
    |
    CD4 (CD4 Molecule)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    20d
    HARMONY LUNG-2: 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 (clinicaltrials.gov)
    P2/3, N=950, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    20d
    HARMONY LUNG-1: 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) (clinicaltrials.gov)
    P2/3, N=850, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    26d
    A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, University of Chicago
    New P2 trial
    |
    carboplatin • paclitaxel • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1m
    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 (clinicaltrials.gov)
    P2, N=195, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    R3767-ONC-2011: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=1546, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2025 --> Mar 2026
    Enrollment closed • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Regeneron Pharmaceuticals | Trial completion date: Nov 2029 --> Dec 2030 | Initiation date: Mar 2025 --> Mar 2026 | Trial primary completion date: Apr 2027 --> Jun 2028
    Trial completion date • Trial initiation date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    2ms
    Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=66, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    New P2 trial
    |
    capecitabine • oxaliplatin • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    LAG-MAPS: Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma (clinicaltrials.gov)
    P2, N=126, Not yet recruiting, Intergroupe Francophone de Cancerologie Thoracique
    New P2 trial
    |
    cisplatin • carboplatin • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    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 (clinicaltrials.gov)
    P2, N=180, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Apr 2029 --> Nov 2029 | Trial primary completion date: Sep 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3ms
    LAG-BOOST: Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, University of Oklahoma
    New P2 trial
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)