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Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02383212
Recruitment Status : Active, not recruiting
First Posted : March 9, 2015
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.

Condition or disease Intervention/treatment Phase
Advanced Cancer Advanced Malignancies Drug: Cemiplimab Radiation: Hypofractionated radiotherapy Drug: Cyclophosphamide Drug: Docetaxel Drug: Carboplatin Drug: GM-CSF Drug: Paclitaxel Drug: Pemetrexed Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
Actual Study Start Date : February 2, 2015
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Arm Intervention/treatment
Experimental: Monotherapy Cohort
Cemiplimab will be administered alone
Drug: Cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Experimental: 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

Drug: Cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Radiation: Hypofractionated radiotherapy
Drug: Cyclophosphamide
Drug: Docetaxel
Experimental: 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

Drug: Cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Radiation: Hypofractionated radiotherapy
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Carboplatin
Drug: GM-CSF
Other Name: LEUKINE®

Drug: Paclitaxel
Drug: Pemetrexed
Experimental: Quadruple Combination Cohorts
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide
Drug: Cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Radiation: Hypofractionated radiotherapy
Drug: Cyclophosphamide
Drug: GM-CSF
Other Name: LEUKINE®




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Change from baseline to week 48 ]
    Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs)

  2. Incidence of abnormal laboratory findings [ Time Frame: Change from baseline to week 48 ]
  3. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Change from baseline to 28 days after first dose of cemiplimab ]

Secondary Outcome Measures :
  1. Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) [ Time Frame: Change from baseline to week 48 ]
  2. Immune-Related Response Criteria (irRC) applied to RECIST measurements [ Time Frame: Change from baseline to week 48 ]
  3. Incidence of development of anti-cemiplimab antibodies [ Time Frame: Up to week 48 ]
  4. Antitumor activity measured by progression-free survival (PFS) [ Time Frame: Up to 72 weeks ]
  5. Antitumor activity measured by overall survival [ Time Frame: Up to 249 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
  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

Key Exclusion Criteria:

  1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
  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

The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial, therefore not all inclusion/ exclusion criteria are listed.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383212


  Hide Study Locations
Locations
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United States, Arizona
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
United States, California
City of Hope National Medical Center
Duarte, California, United States
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
United States, Colorado
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States
United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Indiana
Indiana University
Indianapolis, Indiana, United States
United States, Kansas
University of Kansas Cancer Center
Fairway, Kansas, United States
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, Michigan
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
United States, Missouri
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri, United States
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
United States, New York
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
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States
United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center Shadyside
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Miriam Hospital
Providence, Rhode Island, United States
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
United States, Texas
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
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States
Australia
Peter Maccallum Cancer Centre
Melbourne, Australia
Spain
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
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02383212     History of Changes
Other Study ID Numbers: R2810-ONC-1423
2015-002132-41 ( EudraCT Number )
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Regeneron Pharmaceuticals:
Advanced cancerous growth
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Docetaxel
Cyclophosphamide
Carboplatin
Pemetrexed
Cemiplimab
Sargramostim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological