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Advanced MalignanciesPhase 1NCT03233139

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

A Phase 1 study testing Cemiplimab, Ipilimumab and Platinum-doublet chemotherapy in people with Advanced Malignancies, run by Regeneron Pharmaceuticals at 20 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Malignancies
What is being tested?
Cemiplimab, Ipilimumab and Platinum-doublet chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
20 sitesJapan
Study dates
21 Jun 2017to 30 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • 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
Show all 10Show fewer
  • 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)
  • Note: Other protocol defined inclusion/exclusion criteria apply.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • National Cancer Center Hospital - Tsukiji Campus

    Chuo Ku, Tokyo, 104-0045

  • Kansai Medical University Hirakata Hospital

    Hirakata, Osaka, 573-1191

  • Hiroshima City Hiroshima Citiz

    Hiroshima, 730-8518

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-8550

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • National Hospital Organization Kinki-chuo Chest Medical Center

    Sakai-shi, Osaka, 591-8555

  • Sasebo City General Hospital

    Sasebo, Nagasaki, 857-8511

  • Saitama Cancer Center

    Shinden, Saitama, 362-0806

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 569-8686

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

  • Kanagawa Cancer Center - Thora

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

Official title: A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Cemiplimab (Anti-PD-1) and Other Agents in Japanese Patients With Advanced Malignancies

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.

Being tested
Cemiplimab, Ipilimumab, Platinum-doublet chemotherapy, Gemcitabine, Pemetrexed
Keywords
Japanese patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CemiplimabDrug

    Also called REGN2810, Libtayo

    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.

  • IpilimumabDrug

    To be administered per protocol

  • Platinum-doublet chemotherapyDrug

    To be administered per protocol

  • GemcitabineDrug

    Also called Gemzar

    To be administered per protocol

  • PemetrexedDrug

    Also called Alimta

    To be administered per protocol

  • PaclitaxelDrug

    Also called Taxol

    To be administered per protocol

  • FianlimabDrug

    To be administered per protocol

Study groups in NCT03233139
Study groupRoleWhat they receive
CemiplimabExperimentalPart 1
Receives: Drug: Cemiplimab
Cohort AExperimentalPart 2
Receives: Drug: Cemiplimab
Cohort BExperimentalPart 2
Receives: Drug: Cemiplimab; Drug: Ipilimumab; Drug: Platinum-doublet chemotherapy; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Paclitaxel
Cohort CExperimentalPart 2
Receives: Drug: Cemiplimab; Drug: Platinum-doublet chemotherapy; Drug: Pemetrexed; Drug: Paclitaxel
Cohort DExperimentalPart 2
Receives: Drug: Cemiplimab; Drug: Fianlimab
Cohort EExperimentalPart 2
Receives: Drug: Cemiplimab; Drug: Platinum-doublet chemotherapy; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Fianlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

  5. PK of cemiplimab: Cmax

    Peak serum concentration

    Measured: Up to 136 weeks

  6. PK of cemiplimab: tmax

    Time to Cmax

    Measured: Up to 136 weeks

  7. PK of cemiplimab: Ctrough

    Drug concentration in serum at the end of a dosing interval

    Measured: Up to 136 weeks

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

    AUC over a 3-week dosing interval

    Measured: Up to 136 weeks

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

    Observed terminal half-life

    Measured: Up to 136 weeks

Secondary outcomes (3)

  1. Immunogenicity against cemiplimab and fianlimab

    Evaluate the immunogenicity of cemiplimab and fianlimab after single-dose administration

    Measured: Up to 136 weeks

  2. Objective Response Rate (ORR)

    As assessed by an Independent Review Committee (IRC) using RECIST 1.1 (Eisenhauer 2009) in Part 2, Cohorts A and C

    Measured: Up to 135 weeks

  3. Duration of Response (DOR)

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

    Measured: Up to 136 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2017
  2. Study start21 Jun 2017
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03233139
Sponsor's protocol ID
R2810-ONC-1622
Status last verified
Feb 2026
First submitted
25 Jul 2017
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33146741

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cemiplimab, Ipilimumab and Platinum-doublet chemotherapy in people with Advanced Malignancies, run by Regeneron Pharmaceuticals at 20 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy (time frame: Up to 136 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03233139, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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