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Safety and Pharmacokinetics of REGN2810 (Cemiplimab) (Anti-PD-1) in Japanese Patients With Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03233139
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

The primary objective of the study is to assess the safety, tolerability, and Pharmacokinetics (PK) of cemiplimab in Japanese patients with advanced malignancies.

The secondary objectives are:

  • To assess the immunogenicity of cemiplimab
  • To evaluate tumor response (objective response rate [ORR] and duration of response [DOR] to cemiplimab monotherapy as first line treatment of Japanese patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) (Part 2, Cohort A)
  • To evaluate tumor response ORR and DOR to cemiplimab plus chemotherapy as first line treatment of Japanese patients with advanced squamous or non-squamous NSCLC (Part 2, Cohort C)

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: Cemiplimab Drug: Ipilimumab Drug: Platinum-doublet chemotherapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Investigate the Safety and Pharmacokinetics of REGN2810 (Anti-PD-1) in Japanese Patients With Advanced Malignancies
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : May 24, 2026
Estimated Study Completion Date : May 24, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cemiplimab
Part 1
 Drug: Cemiplimab
Patients will be administered cemiplimab as per protocol
Other Names:
  • REGN2810
  • Libtayo
Experimental: Cohort A
Part 2
 Drug: Cemiplimab
Patients will be administered cemiplimab as per protocol
Other Names:
  • REGN2810
  • Libtayo
Experimental: Cohort B
Part 2
 Drug: Cemiplimab
Patients will be administered cemiplimab as per protocol
Other Names:
  • REGN2810
  • Libtayo

Drug: Ipilimumab
To be administered per protocol

Drug: Platinum-doublet chemotherapy
To be administered per protocol
Experimental: Cohort C
Part 2
 Drug: Cemiplimab
Patients will be administered cemiplimab as per protocol
Other Names:
  • REGN2810
  • Libtayo

Drug: Platinum-doublet chemotherapy
To be administered per protocol


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab [ Time Frame: Up to 136 weeks ]
  2. PK of cemiplimab: Cmax [ Time Frame: Up to 136 weeks ]
    Peak serum concentration

  3. PK of cemiplimab: tmax [ Time Frame: Up to 136 weeks ]
    Time to Cmax

  4. PK of cemiplimab: Ctrough [ Time Frame: Up to 136 weeks ]
    Drug concentration in serum at the end of a dosing interval

  5. PK of cemiplimab: Area under the drug concentration-time curve in serum AUC3w [ Time Frame: Up to 136 weeks ]
    AUC over a 3-week dosing interval

  6. PK of cemiplimab: t½ estimated over a 3-week dosing interval [ Time Frame: Up to 136 weeks ]
    Observed terminal half-life


Secondary Outcome Measures :
  1. Immunogenicity against cemiplimab [ Time Frame: Up to 136 weeks ]
    Evaluate the immunogenicity of cemiplimab after single-dose administration

  2. Objective Response Rate (ORR) [ Time Frame: Up to 135 weeks ]
    As assessed by an Independent Review Committee (IRC) using RECIST 1.1 (Eisenhauer 2009) in Part 2, Cohorts A and C

  3. Duration of Response (DOR) [ Time Frame: Up to 136 weeks ]
    As assessed by an IRC (per RECIST1.1) in Part 2, Cohorts A and C


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Disease types under study:

    • Part 1: Histologically or cytologically confirmed diagnosis of malignancy with no alternative standard-of-care therapeutic option
    • Part 2: Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC or stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC.
    • Patients in Part 2 NSCLC cohorts must have available archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated.
  2. ECOG (Eastern Cooperative Oncology Group) PS (Performance status) ≤1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature [eg, light house work or office work]). Note: Patients with ECOG PS >1 are ineligible.
  3. Patients must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin
  4. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

  1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that requires treatment with systemic immunosuppressive treatments, which may suggest risk for Immune-related adverse event (irAE)s. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement or psoriasis that does not require systemic treatment.
  2. Untreated brain metastasis (es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable, 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.
  3. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab.
  4. Any positive test (ribonucleic acid (RNA) or Deoxyribonucleic acid (DNA) by polymerase chain reaction) for hepatitis B, hepatitis C, or human immunodeficiency virus indicating uncontrolled active or chronic infection.
  5. History of pneumonitis or interstitial lung disease
  6. Surgery within 1 month of first dose and radiation therapy within 2 weeks of first dose
  7. Completed palliative radiation therapy within the prior 2 weeks or has not recovered from any medically significant radiation-related Adverse Event (AE)
  8. Patients that have never smoked, defined as smoking ≤100 cigarettes in a lifetime (Part 2)
  9. Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS1 fusions (Part 2)

Note: Other protocol defined inclusion/exclusion criteria apply.

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): NCT03233139


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
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: NCT03233139    
Other Study ID Numbers: R2810-ONC-1622
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Regeneron Pharmaceuticals:
Japanese patients
Additional relevant MeSH terms:
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Neoplasms
Ipilimumab
Cemiplimab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action