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Trial record 29 of 38 for:    cemiplimab

Safety and Pharmacokinetics of REGN2810 (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 : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objective of the study is to assess the safety, tolerability, and Pharmacokinetics (PK) of REGN2810 in Japanese patients with advanced malignancies. The secondary objective of the study is to assess the immunogenicity of REGN2810.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: REGN2810 Drug: Ipilimumab Drug: Platinum-doublet chemotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 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 : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Arm Intervention/treatment
Experimental: REGN2810
Part 1
Drug: REGN2810
Patients will be administered REGN2810 as per protocol
Other Name: cemiplimab

Experimental: Cohort A
Part 2
Drug: REGN2810
Patients will be administered REGN2810 as per protocol
Other Name: cemiplimab

Experimental: Cohort B
Part 2
Drug: REGN2810
Patients will be administered REGN2810 as per protocol
Other Name: cemiplimab

Drug: Ipilimumab
To be administered per protocol

Drug: Platinum-doublet chemotherapy
To be administered per protocol




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with REGN2810 [ Time Frame: Up to 136 weeks ]
  2. PK of REGN2810: Cmax [ Time Frame: Up to 136 weeks ]
    Peak serum concentration

  3. PK of REGN2810: tmax [ Time Frame: Up to 136 weeks ]
    Time to Cmax

  4. PK of REGN2810: Ctrough [ Time Frame: Up to 136 weeks ]
    Drug concentration in serum at the end of a dosing interval

  5. PK of REGN2810: 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 REGN2810: t½ estimated over a 3-week dosing interval [ Time Frame: Up to 136 weeks ]
    Observed terminal half-life


Secondary Outcome Measures :
  1. Immunogenicity against REGN2810 [ Time Frame: Up to 136 weeks ]
    Evaluate the immunogenicity of REGN2810 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, Cohort A

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



Information from the National Library of Medicine

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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 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 REGN2810.
  3. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810.
  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.


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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Japan
Nagoya Medical Center Recruiting
Nagoya, Aichi, Japan, 460-0001
Kurume University Hospital Recruiting
Kurume, Fukuoka, Japan, 830-0011
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan, 650-0047
Kanazawa University Hospital Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Kitasato University Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0375
Kanagawa Cardiovascular and Respiratory Center Recruiting
Yokohama, Kanagawa, Japan, 236-0051
Kanagawa Cancer Center Recruiting
Yokohama, Kanagawa, Japan, 241-8515
Sasebo City General Hospital Recruiting
Sasebo, Nagasaki, Japan, 857-8511
Kurashiki Central Hospital Recruiting
Kurashiki, Okayama, Japan, 710-8515
Kansai Medical University Hospital Recruiting
Hirakata, Osaka, Japan, 573-1191
Osaka Medical College Hospital Recruiting
Takatsuki, Osaka, Japan, 569-8686
Kinki-Chuo Chest Medical Center Recruiting
Sakai, Osak, Japan, 591-8555
Saitama Cancer Center Recruiting
Kita-adachi, Saitama, Japan, 362-0806
National Cancer Center Hospital Active, not recruiting
Cho-Ku, Tokyo, Japan, 104-0055
Gunma Prefectural Cancer Center Recruiting
Gunma, Japan, 373-8550
Hiroshima City Hiroshima Citizens Hospital Recruiting
Hiroshima, Japan, 730-8518
Nagasaki University Hospital Recruiting
Nagasaki, Japan, 852-8501
Osaka International Cancer Center Recruiting
Osaka, Japan, 541-8567
Osaka International Cancer Institute Recruiting
Osaka, Japan, 541-8567
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Tokushima University Hospital Recruiting
Tokushima, Japan, 770-8503
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03233139     History of Changes
Other Study ID Numbers: R2810-ONC-1622
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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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