Libtayo (cemiplimab-rwlc) / Medison, Regeneron  >>  Phase 1
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34 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Libtayo (cemiplimab-rwlc) / Regeneron
NCT04729725: SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL

Terminated
1b
3
US
Anti-TGF-beta Monoclonal Antibody SAR-439459, Anti-TGFb SAR-439459, Anti-transforming Growth Factor-beta mAb SAR439459, SAR 439459, SAR-439459, SAR439459, Cemiplimab, Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810
M.D. Anderson Cancer Center
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
12/22
12/22
ACTRN12623001077651: A clinical trial to determine the safety and tolerability of GRWD5769 in combination with anticancer treatments in patients with solid malignancies.

Not yet recruiting
1
36
 
Grey Wolf Therapeutics Pty Ltd, Grey Wolf Therapeutics Pty Ltd
Advanced solid malignancies
 
 
NCT03002376: An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

Completed
1
47
Europe, RoW
REGN2810, cemiplimab, Libtayo
Regeneron Pharmaceuticals, Sanofi
Melanoma
03/19
03/20
NCT03198130: An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Patients With Head and Neck Cancer Receiving REGN2810 (Anti-PD-1)

Completed
1
33
Europe, RoW
REGN2810, cemiplimab, Libtayo
Regeneron Pharmaceuticals, Sanofi
Recurrent Squamous Cell Carcinoma of Head, Recurrent Squamous Cell Carcinoma of Neck, Metastatic Squamous Cell Carcinoma of Head, Metastatic Squamous Cell Carcinoma Neck
06/19
02/20
NCT03477864: Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer

Withdrawn
1
0
NA
Ipilimumab, 477202-00-9, 720801, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Yervoy, MDX-CTLA4, MDX-010, Stereotactic Body Radiation Therapy (SBRT), Radical Prostatectomy, Prostatovesiculectomy, Anti-PD-1 Monoclonal Antibody REGN2810
Sidney Kimmel Cancer Center at Thomas Jefferson University, Prostate Cancer Foundation, Regeneron Pharmaceuticals
Stage III Prostate Cancer, Stage IIIA Prostate Cancer, Stage IIIB Prostate Cancer, Stage IIIC Prostate Cancer, Stage IV Prostate Cancer, Stage IVA Prostate Cancer, Stage IVB Prostate Cancer
11/19
11/19
NCT02383212: Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

Checkmark From trial for advanced malignancies
Oct 2020 - Oct 2020: From trial for advanced malignancies
Checkmark Interim data from P1 dose escalation and NSCLC expansion cohort at ASCO-SITC 2019 [screenshot]
Mar 2019 - Mar 2019: Interim data from P1 dose escalation and NSCLC expansion cohort at ASCO-SITC 2019 [screenshot]
Checkmark From study for unresectable locally advanced or metastatic CSCC at ASCO 2018 [screenshot]
More
Completed
1
398
Europe, US, RoW
Cemiplimab, REGN2810, Libtayo, Hypofractionated radiotherapy, Cyclophosphamide, Docetaxel, Carboplatin, GM-CSF, LEUKINE®, Paclitaxel, Pemetrexed
Regeneron Pharmaceuticals, Sanofi
Advanced Cancer, Advanced Malignancies
11/19
11/19
NCT03580694: Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Hourglass Jan 2021 - Dec 2021 : In combination with REGN4659 for advanced NSCLC
Terminated
1
17
US
REGN4659, Cemiplimab, REGN2810
Regeneron Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
12/19
12/19
NCT03192345: A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

Checkmark Data from a trial in combination with SAR439459 for advanced solid tumors at ASCO 2022
Apr 2022 - Apr 2022: Data from a trial in combination with SAR439459 for advanced solid tumors at ASCO 2022
Terminated
1
161
Europe, Canada, US, RoW
SAR439459, Cemiplimab REGN2810
Sanofi
Malignant Solid Tumor
12/21
01/22
NCT03871348: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Checkmark Preliminary data from dose escalation trial in combination with SAR441000 at SITC 2020
Nov 2020 - Nov 2020: Preliminary data from dose escalation trial in combination with SAR441000 at SITC 2020
Terminated
1
77
Europe, US
SAR441000, Cemiplimab REGN2810
Sanofi, BioNTech RNA Pharmaceuticals GmbH
Metastatic Neoplasm
07/22
02/24
NCT04826393: ASP8374 + Cemiplimab in Recurrent Glioma

Active, not recruiting
1
14
US
ASP8374, cemiplimab, Libtayo
Dana-Farber Cancer Institute, Regeneron Pharmaceuticals, Astellas Pharma Inc
Glioblastoma, Recurrent Glioblastoma
10/22
12/24
NCT04460456: A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

Checkmark Interim data in combination with SBT6050 for advanced or metastatic HER2-expressing solid tumor
Sep 2021 - Sep 2021: Interim data in combination with SBT6050 for advanced or metastatic HER2-expressing solid tumor
Active, not recruiting
1
58
US, RoW
SBT6050, pembrolizumab, Cemiplimab
Silverback Therapeutics
HER2 Positive Solid Tumors
12/22
12/22
NCT03889912: Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Hourglass Jul 2020 - Dec 2020 : From trial for neoadjuvant CSCC
Recruiting
1
113
US
Cemiplimab, REGN2810, Libtayo
Regeneron Pharmaceuticals, Sanofi
Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
08/27
10/27
NCT02520245: Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study

Withdrawn
1
0
US
REGN2810
Regeneron Pharmaceuticals
Advanced Malignancies
11/23
11/23
NCT05054348: First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors

Completed
1
91
US
IO-108, IO-108 + pembrolizumab combination therapy, IO-108 + Keytruda combination therapy, IO-108 + cemiplimab combination therapy, IO-108 + Libtayo combination therapy
Immune-Onc Therapeutics, Regeneron Pharmaceuticals
Solid Tumor, Adult
04/24
05/24
NCT06302426: Trial of INI-4001 in Patients With Advanced Solid Tumours

Not yet recruiting
1
50
RoW
INI-4001, Nivolumab, Opdivo, Pembrolizumab, Keytruda, Cemiplimab, Libtayo, Avelumab, Bavencio, Atezolizumab, Tecentriq, Durvalumab, Imfinzi
Inimmune Corporation, Avance Clinical Pty Ltd.
Advanced Solid Tumor
08/24
04/26
NCT05358938: Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Recruiting
1
32
US
Exercise, Checkpoint Blockade, Immune, Avelumab, Cemiplimab, Ipilimumab, Nivolumab, Pembrolizumab
H. Lee Moffitt Cancer Center and Research Institute
Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma
09/24
09/24
NCT06469281: A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers

Not yet recruiting
1
90
US
27T51, Cemiplimab, Libtayo, REGN2810, Bevacizumab, Avastin, Mvasi, Vegzelma, Zirabe
Regeneron Pharmaceuticals
Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
07/28
06/29
NCT04975152: Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma

Recruiting
1
30
US
Cemiplimab-Rwlc, Libtayo
H. Lee Moffitt Cancer Center and Research Institute, Regeneron Pharmaceuticals, Sanofi-Synthelabo
Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
07/24
07/26
NCT04387084: Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy

Recruiting
1
16
US
Atezolizumab, MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq, Avelumab, Bavencio, MSB-0010718C, MSB0010718C, Cemiplimab, Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, Nivolumab, BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Quality-of-Life Assessment, Quality of Life Assessment, Short-Term Fasting, Intermittent Fasting, Short-term Intermittent Fasting
University of Southern California, National Cancer Institute (NCI)
Advanced Malignant Skin Neoplasm, Metastatic Malignant Skin Neoplasm
08/24
08/25
NCT03017820: VSV-hIFNbeta-NIS in Treating Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma

Recruiting
1
120
US
Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Oncolytic VSV-hIFNbeta-NIS, Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Voyager-V1, VSV-expressing hIFNb and NIS, VSV-hIFNb-NIS, VSV-hIFNbeta-NIS, VV1, Single Photon Emission Computed Tomography, Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, ST, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon, Cemiplimab, 1801342-60-8, Cemiplimab RWLC, Cemiplimab-rwlc, Immunoglobulin G4, Anti-(Human Programmed Cell Death Protein 1) (Human Monoclonal REGN2810 Heavy Chain), Disulfide with Human Monoclonal REGN2810 kappa-chain, Libtayo, REGN2810
Mayo Clinic, National Cancer Institute (NCI)
B-Cell Non-Hodgkin Lymphoma, Histiocytic and Dendritic Cell Neoplasm, Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma, Recurrent Mycosis Fungoides, Recurrent Plasma Cell Myeloma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Acute Myeloid Leukemia, Refractory Anaplastic Large Cell Lymphoma, Refractory Angioimmunoblastic T-Cell Lymphoma, Refractory Mycosis Fungoides, Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified, Refractory Plasma Cell Myeloma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma
12/28
04/32
NCT05064085: Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer

Active, not recruiting
1
13
US
Cemiplimab, Libtayo, Capecitabine, Xeloda
H. Lee Moffitt Cancer Center and Research Institute, Regeneron Pharmaceuticals
Hormone Receptor-positive Breast Cancer
09/24
09/25
R3767-ONC-1613, NCT03005782: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

Checkmark Initial results from P1 trial in combination with cemiplimab for unresectable stage IIIB-C or IV NSCLC at ESMO-IO 2022
Dec 2022 - Dec 2022: Initial results from P1 trial in combination with cemiplimab for unresectable stage IIIB-C or IV NSCLC at ESMO-IO 2022
Checkmark Data from trial in combination with fianlimab for 1L melanoma at ESMO 2022
Sep 2022 - Sep 2022: Data from trial in combination with fianlimab for 1L melanoma at ESMO 2022
Checkmark Data from trial in combination with REGN3767 for advanced melanoma at ASCO 2021
More
Completed
1
333
Europe, US, RoW
REGN3767, fianlimab, cemiplimab, REGN2810
Regeneron Pharmaceuticals, Sanofi
Malignancies
04/24
04/24
NCT05376553: Study of Cemiplimab - TP Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Recruiting
1
24
US
Cemiplimab, Cisplatin, Docetaxel
Krzysztof Misiukiewicz, Regeneron Pharmaceuticals
Locally Advanced Head and Neck Squamous Cell Carcinoma
05/25
05/26
LuCa-MERIT-1, NCT05142189: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Recruiting
1
130
Europe, US, RoW
BNT116, Cemiplimab, Docetaxel, Carboplatin, Paclitaxel
BioNTech SE
Non-Small Cell Lung Cancer
01/26
08/27
NCT05704634: A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.

Recruiting
1
56
US
Cemiplimab, Kevzara (Sarilumab)
M.D. Anderson Cancer Center, Regeneron Pharmaceuticals
Lung Cancer
01/26
01/28
ON-5001, NCT06022029: A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.

Recruiting
1
168
US
ONM-501, Cemiplimab, Libtayo
OncoNano Medicine, Inc.
Triple Negative Breast Cancer, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Lymphoma, Non-Hodgkin, Mantle Cell Lymphoma, Bladder Cancer, Uveal Melanoma, Recurrent, Cervix Cancer, Carcinoma in Situ, Head and Neck Squamous Cell Carcinoma, Skin Cancer, Metastatic Cancer, Tumor, Solid, Tumor Recurrence
04/26
08/26
NCT04722523: A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer

Recruiting
1
30
US
Cisplatin, Carboplatin, Docetaxel, Cetuximab, Cemiplimab, Surgical Resection of Primary +/- Neck Dissection, Post-operative radiation therapy
Memorial Sloan Kettering Cancer Center, Regeneron Pharmaceuticals
Head and Neck Cancer, Head Cancer, Head Cancer Neck, Neck Cancer, Head and Neck Squamous Cell Carcinoma, HNSCC
06/26
06/26
NCT05729139: Cemiplimab/Peg-Interferon-α in Advanced CSCC

Withdrawn
1
21
US
Cemiplimab-Rwlc, Libtayo, PEG-IFN alfa-2a, PEGASYS
Baptist Health South Florida, Regeneron Pharmaceuticals
Cutaneous Squamous Cell Carcinoma, Squamous Cell Carcinoma, Advanced Squamous Cell Carcinoma
07/26
07/28
NCT04465487: Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

Recruiting
1
85
Europe, US
REGN6569, Cemiplimab, REGN2810, Libtayo
Regeneron Pharmaceuticals
Squamous Cell Carcinoma of Head and Neck
04/25
06/26
NCT05259709: A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab

Recruiting
1
50
Europe
89Zr˗DFO˗REGN5054, cemiplimab, REGN2810, Libtayo
Regeneron Pharmaceuticals
Advanced Solid Tumor, Metastatic Solid Tumor
09/26
09/26
CLIO-1, NCT02651662 / 2015-001697-17: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

Checkmark Data from monotherapy or in combination with REGN1979 at ASH 2017 [screenshot]
Dec 2017 - Dec 2017: Data from monotherapy or in combination with REGN1979 at ASH 2017 [screenshot]
Recruiting
1
62
Europe, US
cemiplimab, REGN2810, Libtayo, odronextamab, REGN1979
Regeneron Pharmaceuticals
Relapsed/Refractory Aggressive B-Cell Lymphoma
12/26
12/26
LINKER-MM2, NCT05137054: A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Recruiting
1
317
Europe, US
Linvoseltamab, REGN5458, Daratumumab, Darzalex®; Darzalex Faspro™, Carfilzomib, Kyprolis®, Lenalidomide, Revlimid®, Bortezomib, Velcade®, Pomalidomide, Imnovid, Pomalyst®, Isatuximab, Sarclisa®, Fianlimab, REGN3767, Cemiplimab, LIBTAYO, Nirogacestat, PF-03084014
Regeneron Pharmaceuticals
Multiple Myeloma
03/27
01/33
NCT03233139: Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

Checkmark From trial for advanced malignancies in Japanese patients at ASCO-SITC 2019 [screenshot]
Mar 2019 - Mar 2019: From trial for advanced malignancies in Japanese patients at ASCO-SITC 2019 [screenshot]
Recruiting
1
145
Japan
Cemiplimab, REGN2810, Libtayo, Ipilimumab, Platinum-doublet chemotherapy, Gemcitabine, Gemzar, Pemetrexed, Alimta, Paclitaxel, Taxol, Fianlimab
Regeneron Pharmaceuticals
Advanced Malignancies
12/27
03/30
Winship4851-19, NCT04428671: Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer

Recruiting
1
20
US
Cemiplimab, Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN2810, Radiation Therapy, Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation, Therapeutic Conventional Surgery
Emory University, National Cancer Institute (NCI)
Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma
10/30
10/30

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