Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
NCT ID: NCT02383212
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
398 participants
INTERVENTIONAL
2015-02-02
2019-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy Cohort
Cemiplimab will be administered alone
Cemiplimab
Dual Combination Cohorts
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy
Doses of cemiplimab will be administered in combination with Cyclophosphamide
Doses of cemiplimab will be administered in combination with Docetaxel
Cemiplimab
Hypofractionated radiotherapy
Cyclophosphamide
Docetaxel
Triple Combination Cohorts
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF
Doses of cemiplimab will be administered in combination with Carboplatin plus Paclitaxel
Doses of cemiplimab will be administered in combination with Carboplatin plus Pemetrexed
Doses of cemiplimab will be administered in combination with Carboplatin plus Docetaxel
Cemiplimab
Hypofractionated radiotherapy
Cyclophosphamide
Docetaxel
Carboplatin
GM-CSF
Paclitaxel
Pemetrexed
Quadruple Combination Cohorts
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide
Cemiplimab
Hypofractionated radiotherapy
Cyclophosphamide
GM-CSF
Interventions
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Cemiplimab
Hypofractionated radiotherapy
Cyclophosphamide
Docetaxel
Carboplatin
GM-CSF
Paclitaxel
Pemetrexed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
4. Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply).
5. Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Western Regional Medical Center
Goodyear, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Cancer Center
Fairway, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Laura & Isaac Perlmutter Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center Shadyside
Pittsburgh, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Mary Crowley Cancer Research Center - Medical City
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Peter Maccallum Cancer Centre
Melbourne, , Australia
Institut Catala d'Oncologia L'hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Countries
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References
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Babiker H, Brana I, Mahadevan D, Owonikoko T, Calvo E, Rischin D, Moreno V, Papadopoulos KP, Crittenden M, Formenti S, Giralt J, Garrido P, Soria A, Hervas-Moron A, Mohan KK, Fury M, Lowy I, Mathias M, Feng M, Li J, Stankevich E. Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Oncologist. 2021 Sep;26(9):e1508-e1513. doi: 10.1002/onco.13810. Epub 2021 May 22.
Moreno V, Garrido P, Papadopoulos KP, De Miguel Luken MJ, Gil-Martin M, Aljumaily R, Rosen LS, Rietschel P, Mohan KK, Yoo SY, Stankevich E, Lowy I, Fury MG. Tolerability and antitumor activity of cemiplimab, a human monoclonal anti-PD-1, as monotherapy in patients with pretreated non-small cell lung cancer (NSCLC): Data from the Phase 1 NSCLC expansion cohort. Lung Cancer. 2021 May;155:151-155. doi: 10.1016/j.lungcan.2021.02.034. Epub 2021 Mar 4.
Rischin D, Migden MR, Lim AM, Schmults CD, Khushalani NI, Hughes BGM, Schadendorf D, Dunn LA, Hernandez-Aya L, Chang ALS, Modi B, Hauschild A, Ulrich C, Eigentler T, Stein B, Pavlick AC, Geiger JL, Gutzmer R, Alam M, Okoye E, Mathias M, Jankovic V, Stankevich E, Booth J, Li S, Lowy I, Fury MG, Guminski A. 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. J Immunother Cancer. 2020 Jun;8(1):e000775. doi: 10.1136/jitc-2020-000775.
Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
Falchook GS, Leidner R, Stankevich E, Piening B, Bifulco C, Lowy I, Fury MG. Responses of metastatic basal cell and cutaneous squamous cell carcinomas to anti-PD1 monoclonal antibody REGN2810. J Immunother Cancer. 2016 Nov 15;4:70. doi: 10.1186/s40425-016-0176-3. eCollection 2016.
Other Identifiers
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2015-002132-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R2810-ONC-1423
Identifier Type: -
Identifier Source: org_study_id
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