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

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ClinicalTrials.gov Identifier: NCT02383212
Recruitment Status : Completed
First Posted : March 9, 2015
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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

Study Design
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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
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019
Arms and Interventions
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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®


Outcome Measures
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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 ]

Eligibility Criteria
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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.

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02383212    
Other Study ID Numbers: R2810-ONC-1423
2015-002132-41 ( EudraCT Number )
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Regeneron Pharmaceuticals:
Advanced cancerous growth
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Docetaxel
Cyclophosphamide
Carboplatin
Pemetrexed
Cemiplimab
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