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NeoplasmsPhase 1/2NCT02908906

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers

A Phase 1/2 study testing JNJ-63723283 in people with Neoplasms, run by Janssen Research & Development, LLC at 20 sites in 7 countries.

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

The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
JNJ-63723283
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
20 sitesin 7 countries
Study dates
21 Nov 2016to 31 Dec 2026
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
  • Parts 1-4: Has thyroid function laboratory values within normal range
  • Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test
  • Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
  • Parts 1 to 4: Have evaluable disease

Who cannot join

  • Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
  • Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody
  • Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
  • Grade 3 or higher toxicity effects from previous treatment with immunotherapy
  • A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug

Trial locations and contacts

20 sites in 7 countries.

20 sites in 7 countries

Spain7 sites

  • Study site

    Badalona

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Pamplona

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

United Kingdom4 sites

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Newcastle upon Tyne

Other trials in United Kingdom

Russia3 sites

  • Study site

    Moscow

  • Study site

    Pyatigorsk

  • Study site

    Saint Petersburg

Other trials in Russia

United States2 sites

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    St Louis, Missouri

Other trials in United States

Poland2 sites

  • Study site

    Bialystok

  • Study site

    Warsaw

Other trials in Poland

Moldova1 site

  • Study site

    Chisinau

Other trials in Moldova

Sweden1 site

  • Study site

    Gothenburg

Other trials in Sweden

About this study

Official title: 63723283LUC1001: A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancers

The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2, to determine one or more additional RP2Ds in Parts 3 and 4.

Conditions
Neoplasms
Being tested
JNJ-63723283
Medical subject headings
Neoplasms

What participants receive

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

  • JNJ-63723283Drug

    Also called Cetrelimab

    JNJ-63723283 will be administered by IV infusion or SC injection or infusion.

Study groups in NCT02908906
Study groupRoleWhat they receive
JNJ-63723283ExperimentalIn Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenous (IV) every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses, dose administration routes (subcutaneous [SC] or IV), and dose schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1. In Part 3, participants will receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD) and safety. In Part 4, participants will receive JNJ-63723283 at the dose level determined in Part 3. Additional cohorts may be enrolled in Part 4.
Receives: Drug: JNJ-63723283

What is being measured

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

  1. Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT)

    Frequency and severity of dose-limiting toxicity will be reported.

    Measured: Up to 2 years 6 months

  2. Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors

    Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

    Measured: Up to 2 years 6 months

  3. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau])

    AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.

    Measured: Up to 2 years 6 months

Secondary outcomes (20)

  1. Parts 1, 2, 3, and 4 : Number of Participants With Adverse Events (AEs) as a Measure of Safety

    An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

    Measured: Up to 2 years 6 months

  2. Parts 1, 2 and 3, and 4: Maximum Observed Serum Concentration (Cmax)

    The Cmax is the maximum observed serum concentration.

    Measured: Up to 2 years 6 months

  3. Parts 1 and 2: Area Under the Serum Concentration Versus Time Curve Between time t1 and t2 (AUC [t1-t2])

    AUC (t1-t2) is defined as the area under the serum concentration versus time curve between time t1 and t2.

    Measured: Up to 2 years 6 months

  4. Parts 1, 2 and 3: Elimination Half-Life (t1/2)

    The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration.

    Measured: Up to 2 years 6 months

  5. Parts 1 and 2: Total Systemic Clearance of (CL)

    Total systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.

    Measured: Up to 2 years 6 months

  6. Parts 1 and 2: Volume of Distribution at Steady-State (Vss)

    The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of JNJ-63723283 at steady state.

    Measured: Up to 2 years 6 months

  7. Parts 1 and 2: Accumulation Ratio (R)

    The R is obtained by dividing AUC at two different time points.

    Measured: Up to 2 years 6 months

  8. Parts 3 and 4: Average Concentration (Cavg) of JNJ-63723283

    Cavg of JNJ-63723283 will be reported.

    Measured: Up to 2 years 6 months

  9. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve Between Time Zero and Time t (AUC [0-t])

    AUC (0-t) is defined as area under the serum concentration versus time curve between time zero and time t.

    Measured: Up to 2 years 6 months

  10. Parts 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity])

    AUC (0-infinity) is defined as area under the serum concentration versus time curve from time zero to infinity.

    Measured: Up to 2 years 6 months

  11. Parts 3 and 4: Concentration Observed at the Last Timepoint Prior to Dosing (Ctrough)

    Ctrough is defined as the concentration observed at the last timepoint prior to dosing.

    Measured: Up to 2 years 6 months

  12. Parts 1, 2, 3, and 4: Presence of Anti-JNJ-63723283 Antibodies and Effect on Serum JNJ-63723283 Concentrations

    Serum samples will be analyzed for antibodies to JNJ-63723283. The titer of the confirmed positive samples will be reported.

    Measured: Up to 2 years 6 months

  13. Parts 1, 2, 3, and 4: Overall Response Rate (ORR) per Immune-Related Response Criteria (irRC)

    ORR is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on irRC criteria.

    Measured: Up to 2 years 6 months

  14. Parts 1, 2, 3, and 4: Duration of Response (DOR) per RECIST v1.1

    For Participants who achieve CR or PR, DOR will be calculated as time from initial response of CR or partial response (PR) to progressive disease or death due to underlying disease whichever comes first.

    Measured: Up to 2 years 6 months

  15. Parts 1, 2, 3, and 4: Duration of Response (DOR) per irRC

    For Participants who achieve CR or PR (defined by irRC), DOR will be calculated as time from initial response of CR or partial response (PR) to progressive disease or death due to underlying disease whichever comes first.

    Measured: Up to 2 years 6 months

  16. Parts 1, 2, 3, and 4: Clinical Benefit Rate (CBR) per RECIST v1.1

    The CBR is defined as the percentage of participants who achieve CR, PR or stable disease (SD; greater than or equal to [>=] 24 weeks from the 1st study drug) based on RECIST v1.1 criteria.

    Measured: Up to 2 years 6 months

  17. Parts 1, 2, 3, and 4: Clinical Benefit Rate per irRC

    The CBR is defined as the percentage of participants who achieve CR, PR or SD (>= 24 weeks from the 1st study drug) based on irRC criteria.

    Measured: Up to 2 years 6 months

  18. Parts 1, 2, 3, and 4: Progression-free Survival (PFS) per RECIST v1.1

    The time from first dose of JNJ-63723283 to progressive disease as defined by RECIST v 1.1 or death due to any cause.

    Measured: Up to 2 years 6 months

  19. Parts 1, 2, 3, and 4: Progression-free Survival (PFS) per irRC

    The time from first dose of JNJ-63723283 to progressive disease as defined by irRC or death due to any cause.

    Measured: Up to 2 years 6 months

  20. Parts 1, 2, 3, and 4: Overall Survival (OS)

    The time from first dose of JNJ-63723283 to death due to any cause.

    Measured: Up to 2 years 6 months

Timeline

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

  1. First posted21 Sep 2016 (estimated)
  2. Study start21 Nov 2016
  3. Primary completion17 Nov 2023
  4. Study completion31 Dec 2026 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02908906
Sponsor's protocol ID
CR108223
Other IDs
63723283LUC1001, 2016-002017-22, 2023-506144-16-00, 2023, 2016
Status last verified
Aug 2026
First submitted
19 Sep 2016
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Rutkowski P, Kowalski DM, Moreno V, Calvo A, Thistlethwaite F, Plummer R, Steinbach D, Loffredo J, Akapeme S, Jonathan D, Philip V, Girvin A, Hampras S, Hellemans P, Bulat I. A phase I study evaluating subcutaneous administration of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced solid malignancies. Cancer Immunol Immunother. 2026 Jun 18. doi: 10.1007/s00262-026-04457-1. Online ahead of print.

    PubMed 42313189

  • Felip E, Moreno V, Morgensztern D, Curigliano G, Rutkowski P, Trigo JM, Calvo A, Kowalski D, Cortinovis D, Plummer R, Maio M, Ascierto PA, Vladimirov VI, Cervantes A, Zudaire E, Hazra A, T'jollyn H, Bandyopadhyay N, Greger JG, Attiyeh E, Xie H, Calvo E. First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. Cancer Chemother Pharmacol. 2022 Apr;89(4):499-514. doi: 10.1007/s00280-022-04414-6. Epub 2022 Mar 17.

    PubMed 35298698

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JNJ-63723283 in people with Neoplasms, run by Janssen Research & Development, LLC at 20 sites in 7 countries.

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 6 inclusion and 5 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 31 Aug 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 Spain, United Kingdom, Russia, United States, Poland and 2 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT) (time frame: Up to 2 years 6 months). The study lists 3 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 NCT02908906, which also lists 2 linked publications.

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 31 Aug 2026.

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