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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03233139
Collaborator
(none)
117
Enrollment
21
Locations
4
Arms
107.1
Anticipated Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 21, 2017
Anticipated Primary Completion Date :
May 24, 2026
Anticipated Study Completion Date :
May 24, 2026

Arms and Interventions

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

    Primary Outcome Measures

    1. Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab [Up to 136 weeks]

    2. PK of cemiplimab: Cmax [Up to 136 weeks]

      Peak serum concentration

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

      Time to Cmax

    4. PK of cemiplimab: Ctrough [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 [Up to 136 weeks]

      AUC over a 3-week dosing interval

    6. PK of cemiplimab: t½ estimated over a 3-week dosing interval [Up to 136 weeks]

      Observed terminal half-life

    Secondary Outcome Measures

    1. Immunogenicity against cemiplimab [Up to 136 weeks]

      Evaluate the immunogenicity of cemiplimab after single-dose administration

    2. Objective Response Rate (ORR) [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) [Up to 136 weeks]

      As assessed by an IRC (per RECIST1.1) in Part 2, Cohorts A and C

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    1. Patients must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin

    2. 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

    Note: Other protocol defined inclusion/exclusion criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya Medical Center Nagoya Aichi Japan 460-0001
    2 Kurume University Hospital Kurume Fukuoka Japan 830-0011
    3 Kobe City Medical Center General Hospital Kobe Hyogo Japan 650-0047
    4 Kanazawa University Hospital Kanazawa Ishikawa Japan 920-8641
    5 Kitasato University Hospital Sagamihara Kanagawa Japan 252-0375
    6 Kanagawa Cardiovascular and Respiratory Center Yokohama Kanagawa Japan 236-0051
    7 Kanagawa Cancer Center Yokohama Kanagawa Japan 241-8515
    8 Sasebo City General Hospital Sasebo Nagasaki Japan 857-8511
    9 Kurashiki Central Hospital Kurashiki Okayama Japan 710-8515
    10 Kansai Medical University Hospital Hirakata Osaka Japan 573-1191
    11 Kinki-Chuo Chest Medical Center Sakai Osaka Japan 591-8555
    12 Osaka Medical College Hospital Takatsuki Osaka Japan 569-8686
    13 Saitama Cancer Center Kita Adachi Saitama Japan 362-0806
    14 National Cancer Center Hospital Cho-Ku Tokyo Japan 104-0055
    15 Tokyo Medical University Hospital Shinjuku Tokyo Japan 160-0023
    16 Gunma Prefectural Cancer Center Gunma Japan 373-8550
    17 Hiroshima City Hiroshima Citizens Hospital Hiroshima Japan 730-8518
    18 Nagasaki University Hospital Nagasaki Japan 852-8501
    19 Osaka International Cancer Center Osaka Japan 541-8567
    20 Osaka City University Hospital Osaka Japan 545-8586
    21 Tokushima University Hospital Tokushima Japan 770-8503

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03233139
    Other Study ID Numbers:
    • R2810-ONC-1622
    First Posted:
    Jul 28, 2017
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Dec 1, 2021
    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:
    Neoplasms
    Ipilimumab
    Cemiplimab

    Study Results

    No Results Posted as of Jan 24, 2022