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Active, not recruiting Phase 1

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

NCT03233139 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1
Started
2017-06-21
Last updated
2026-02-12

Condition(s) studied

Advanced Malignancies

Investigational drug(s) / intervention(s)

Cemiplimab →Ipilimumab →Platinum-doublet chemotherapyGemcitabine →Pemetrexed →Paclitaxel →Fianlimab →

Cemiplimab: 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.

Ipilimumab: To be administered per protocol

Platinum-doublet chemotherapy: To be administered per protocol

Gemcitabine: To be administered per protocol

Pemetrexed: To be administered per protocol

Paclitaxel: To be administered per protocol

Fianlimab: To be administered per protocol

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
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. 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 \[eg, light housework or office work\]). 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 5. 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. 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-mediated adverse event (imAE)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.

Primary outcome measure(s)

  • 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 — Up to 136 weeks
    Peak serum concentration
  • PK of cemiplimab: tmax — Up to 136 weeks
    Time to Cmax
  • PK of cemiplimab: Ctrough — Up to 136 weeks
    Drug concentration in serum at the end of a dosing interval
  • PK of cemiplimab: Area under the drug concentration-time curve in serum (AUC3w) — Up to 136 weeks
    AUC over a 3-week dosing interval
  • PK of cemiplimab: t½ estimated over a 3-week dosing interval — Up to 136 weeks
    Observed terminal half-life

Trial sites (20)

FacilityCityRegionStatus
National Hospital Organization Nagoya Medical Center Nagoya Aichi-ken
Kurume University Hospital Kurume Fukuoka
Gunma Prefectural Cancer Center Ōta Gunma
Kobe City Medical Center General Hospital Kobe Hyōgo
Kanazawa University Hospital Kanazawa Ishikawa-ken
Kitasato University Hospital Sagamihara Kanagawa
Kanagawa Cardiovascular and Respiratory Center Yokohama Kanagawa
Kanagawa Cancer Center - Thora Yokohama Kanagawa
Sasebo City General Hospital Sasebo Nagasaki
Kurashiki Central Hospital Kurashiki Okayama-ken
Kansai Medical University Hirakata Hospital Hirakata Osaka
Osaka Metropolitan University Hospital Osaka Osaka
National Hospital Organization Kinki-chuo Chest Medical Center Sakai-shi Osaka
Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka
Saitama Cancer Center Shinden Saitama
National Cancer Center Hospital - Tsukiji Campus Chuo Ku Tokyo
Hiroshima City Hiroshima Citiz Hiroshima Japan
Nagasaki University Hospital Nagasaki Japan
Osaka International Cancer Institute Osaka Japan
Tokushima University Hospital Tokushima Japan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03233139 on ClinicalTrials.gov ↗ ← All trials in Japan