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

NCT ID: NCT03233139

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-21
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cemiplimab

Part 1

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: 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.

Cohort A

Part 2

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: 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.

Cohort B

Part 2

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: 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.

Ipilimumab

Intervention Type: DRUG

To be administered per protocol

Platinum-doublet chemotherapy

Intervention Type: DRUG

To be administered per protocol

Gemcitabine

Intervention Type: DRUG

To be administered per protocol

Pemetrexed

Intervention Type: DRUG

To be administered per protocol

Paclitaxel

Intervention Type: DRUG

To be administered per protocol

Cohort C

Part 2

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: 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.

Platinum-doublet chemotherapy

Intervention Type: DRUG

To be administered per protocol

Pemetrexed

Intervention Type: DRUG

To be administered per protocol

Paclitaxel

Intervention Type: DRUG

To be administered per protocol

Cohort D

Part 2

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: 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.

Fianlimab

Intervention Type: DRUG

To be administered per protocol

Cohort E

Part 2

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: 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.

Platinum-doublet chemotherapy

Intervention Type: DRUG

To be administered per protocol

Pemetrexed

Intervention Type: DRUG

To be administered per protocol

Paclitaxel

Intervention Type: DRUG

To be administered per protocol

Fianlimab

Intervention Type: DRUG

To be administered per protocol

Interventions

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.

Intervention Type: DRUG

Ipilimumab

To be administered per protocol

Intervention Type: DRUG

Platinum-doublet chemotherapy

To be administered per protocol

Intervention Type: DRUG

Gemcitabine

To be administered per protocol

Intervention Type: DRUG

Pemetrexed

To be administered per protocol

Intervention Type: DRUG

Paclitaxel

To be administered per protocol

Intervention Type: DRUG

Fianlimab

To be administered per protocol

Intervention Type: DRUG

Other Intervention Names

REGN2810; Libtayo; Gemzar; Alimta; Taxol

Eligibility Criteria

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.

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

Kanagawa Cancer Center - Thora

Yokohama, Kanagawa, Japan

Sasebo City General Hospital

Sasebo, Nagasaki, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

National Hospital Organization Kinki-chuo Chest Medical Center

Sakai-shi, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Saitama Cancer Center

Shinden, Saitama, Japan

National Cancer Center Hospital - Tsukiji Campus

Chuo Ku, Tokyo, Japan

Hiroshima City Hiroshima Citiz

Hiroshima, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Osaka International Cancer Institute

Osaka, , Japan

Tokushima University Hospital

Tokushima, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 33146741 (View on PubMed)

Other Identifiers

R2810-ONC-1622

Identifier Type: -

Identifier Source: org_study_id