Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

NCT03233139 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: R2810-ONC-1622
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 20

Brief Summary

Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics of cemiplimab in patients with lung cancer. The study is also being conducted to test if cemiplimab, alone or in combination, can reduce the size of your tumor by helping the immune system destroy the tumor. Part 2 Cohorts D and E This study is being conducted to test the safety and pharmacokinetics of fianlimab and cemiplimab in patients with lung cancer. The study is also being conducted to test if fianlimab and cemiplimab, with or without chemotherapy, can reduce the size of your tumor by helping the immune system destroy the tumor.

Conditions

Advanced Malignancies

Keywords

Japanese patients

Outcome Measures

Primary Outcomes (9)

• Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy

  Up to 136 weeks

• Incidence and severity of TEAEs in patients treated with cemiplimab in combination with other agents

  Up to 136 weeks

• Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab without chemotherapy

  Up to 136 weeks

• Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab with chemotherapy

  Up to 136 weeks

• PK of cemiplimab: Cmax

  Peak serum concentration

  Up to 136 weeks

• PK of cemiplimab: tmax

  Time to Cmax

  Up to 136 weeks

• PK of cemiplimab: Ctrough

  Drug concentration in serum at the end of a dosing interval

  Up to 136 weeks

• PK of cemiplimab: Area under the drug concentration-time curve in serum (AUC3w)

  AUC over a 3-week dosing interval

  Up to 136 weeks

• PK of cemiplimab: t½ estimated over a 3-week dosing interval

  Observed terminal half-life

  Up to 136 weeks

Secondary Outcomes (3)

• Immunogenicity against cemiplimab and fianlimab

  Up to 136 weeks

• Objective Response Rate (ORR)

  Up to 135 weeks

• Duration of Response (DOR)

  Up to 136 weeks

Study Arms (6)

Cemiplimab

EXPERIMENTAL

Part 1

Drug: Cemiplimab

Cohort A

EXPERIMENTAL

Part 2

Drug: Cemiplimab

Cohort B

EXPERIMENTAL

Part 2

Drug: Cemiplimab; Drug: Ipilimumab; Drug: Platinum-doublet chemotherapy; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Paclitaxel

Cohort C

EXPERIMENTAL

Part 2

Drug: Cemiplimab; Drug: Platinum-doublet chemotherapy; Drug: Pemetrexed; Drug: Paclitaxel

Cohort D

EXPERIMENTAL

Part 2

Drug: Cemiplimab; Drug: Fianlimab

Cohort E

EXPERIMENTAL

Part 2

Drug: Cemiplimab; Drug: Platinum-doublet chemotherapy; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Fianlimab

Interventions

Cemiplimab DRUG

Patients will be administered cemiplimab as per protocol. For Cohort A Only, patients with confirmed progressive disease may opt to receive up to 4 cycles of platinum doublet chemotherapy in addition to cemiplimab per investigator's judgement.

Also known as: REGN2810, Libtayo

Cemiplimab; Cohort A; Cohort B; Cohort C; Cohort D; Cohort E

Ipilimumab DRUG

To be administered per protocol

Cohort B

Platinum-doublet chemotherapy DRUG

To be administered per protocol

Cohort B; Cohort C; Cohort E

Gemcitabine DRUG

To be administered per protocol

Also known as: Gemzar

Cohort B

Pemetrexed DRUG

To be administered per protocol

Also known as: Alimta

Cohort B; Cohort C; Cohort E

Paclitaxel DRUG

To be administered per protocol

Also known as: Taxol

Cohort B; Cohort C; Cohort E

Fianlimab DRUG

To be administered per protocol

Cohort D; Cohort E

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 \[eg, light housework or office work\]). Note: Patients with ECOG PS \>1 are ineligible.
• Patients must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin
• Willing and able to comply with clinic visits and study-related procedures
• For Part 2, Cohorts D and E: Available tissue for retrospective testing using assay performed by a central laboratory, as specified in the study manual.

You may not qualify if:

• 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.
• Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab.
• 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.
• History of pneumonitis or interstitial lung disease
• Surgery within 1 month of first dose and radiation therapy within 2 weeks of first dose
• Completed palliative radiation therapy within the prior 2 weeks or has not recovered from any medically significant radiation-related Adverse Event (AE)
• Patients that have never smoked, defined as smoking ≤100 cigarettes in a lifetime (Part 2)
• Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS1 fusions (Part 2)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (20)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Gunma Prefectural Cancer Center

Ōta, Gunma, 373-8550, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0375, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, 236-0051, Japan

Location

Kanagawa Cancer Center - Thora

Yokohama, Kanagawa, 241-8515, Japan

Location

Sasebo City General Hospital

Sasebo, Nagasaki, 857-8511, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, 573-1191, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka, 545-8586, Japan

Location

National Hospital Organization Kinki-chuo Chest Medical Center

Sakai-shi, Osaka, 591-8555, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

Location

Saitama Cancer Center

Shinden, Saitama, 362-0806, Japan

Location

National Cancer Center Hospital - Tsukiji Campus

Chuo Ku, Tokyo, 104-0045, Japan

Location

Hiroshima City Hiroshima Citiz

Hiroshima, 730-8518, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Related Publications (1)

• Kitano S, Shimizu T, Koyama T, Ebata T, Iwasa S, Kondo S, Shimomura A, Fujiwara Y, Yamamoto N, Paccaly A, Li S, Rietschel P, Sims T. Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies. Cancer Chemother Pharmacol. 2021 Jan;87(1):53-64. doi: 10.1007/s00280-020-04161-6. Epub 2020 Nov 4.

  PMID: 33146741 DERIVED

MeSH Terms

Interventions

cemiplimab; Ipilimumab; Gemcitabine; Pemetrexed; Paclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 28, 2017
• Study Start: June 21, 2017
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

JP (20)