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New immunotherapy shows promise against multiple advanced cancers

NCT ID NCT02908906

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This study tests a new drug called Cetrelimab (JNJ-63723283) in 234 people with advanced solid tumors like lung, melanoma, bladder, and colorectal cancers. The drug works by blocking PD-1, a protein that stops the immune system from attacking cancer cells. The trial has two parts: first to find the safest dose, then to see how well it shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cetrelimab (JNJ-63723283), an immunotherapy drug that helps the immune system attack cancer cells
What this could lead to
If successful, this could provide a new treatment option for several advanced cancers, potentially shrinking tumors and extending life.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the drug may not work for many people. Immunotherapy can cause serious side effects like inflammation in healthy organs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

234 people

The number who actually took part.

Started

Nov 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

colorectal cancer esophageal cancer gastric cancer gastroesophageal cancer Lynch syndrome melanoma neoplasm non-small cell lung carcinoma renal carcinoma small cell lung carcinoma urinary bladder carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms

Contacts and locations

Locations

  • Study site

    St Louis, Missouri, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

  • Study site

    Chisinau, Moldova

  • Study site

    Bialystok, Poland

  • Study site

    Warsaw, Poland

  • Study site

    Moscow, Russia

  • Study site

    Pyatigorsk, Russia

  • Study site

    Saint Petersburg, Russia

  • Study site

    Badalona, Spain

  • Study site

    Barcelona, Spain

  • Study site

    Madrid, Spain

  • Study site

    Málaga, Spain

  • Study site

    Pamplona, Spain

  • Study site

    Seville, Spain

  • Study site

    Valencia, Spain

  • Study site

    Gothenburg, Sweden

  • Study site

    Glasgow, United Kingdom

  • Study site

    London, United Kingdom

  • Study site

    Manchester, United Kingdom

  • Study site

    Newcastle upon Tyne, United Kingdom

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