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New hope for kids with tough cancers: immunotherapy drug tested

NCT ID NCT02332668

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Updated 2 times

Summary

This study tests pembrolizumab, a drug that helps the immune system fight cancer, in children aged 6 months to 18 years with advanced melanoma, solid tumors, or lymphoma that has spread, returned, or not responded to other treatments. The main goal is to see if the drug can shrink tumors. The study is currently recruiting participants.

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

About 370 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2015

Expected to finish

Feb 2028

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

6 months to 17 years

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: * Between 6 months and \<18 years of age on day of signing informed consent is documented. * Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate * Any number of prior treatment regimens * Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma * Measurable disease based on RECIST 1.1 (Or based on IWG \[Cheson, 2007\] \[i.e., measurement must be \>15 mm in longest diameter or \>10 mm in short axis\] for rrcHL participants) * Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled * Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants \>16 years of age * Adequate organ function * Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication * Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of study intervention * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Demonstrate adequate organ function. Exclusion Criteria: * Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation/randomization * Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization * Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent * Prior radiotherapy within 2 weeks of start of study treatment * Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Tumor(s) involving the brain stem * Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients * Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Active infection requiring systemic therapy * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication * Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 \[CTLA-4\], OX-40, CD137) * Human immunodeficiency virus (HIV) * Hepatitis B or C * Known history of active tuberculosis (TB; Bacillus tuberculosis) * Received a live vaccine within 30 days of planned start of study medication * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant \>5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease \[GVHD\].) * History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study * Known psychiatric or substance abuse disorders that would interfere with the requirements of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Call for Information (Investigational Site 0019)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Call for Information (Investigational Site 0024)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Call for Information (Investigational Site 0026)

    RECRUITING

    Boston, Massachusetts, 02445, United States

  • Call for Information (Investigational Site 0031)

    RECRUITING

    New York, New York, 10032, United States

  • Call for Information (Investigational Site 0054)

    RECRUITING

    Dallas, Texas, 75235, United States

  • Call for Information (Investigational Site 0070)

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Call for Information (Investigational Site 0071)

    RECRUITING

    Sioux Falls, South Dakota, 57117, United States

  • MSD Brasil

    RECRUITING

    São Paulo, Brazil

  • MSD France

    RECRUITING

    Paris, France

  • MSD Italia S.r.l.

    RECRUITING

    Rome, Italy

  • MSD Korea LTD

    RECRUITING

    Seoul, 4130, South Korea

  • MSD Sharp & Dohme GmbH

    RECRUITING

    München, Germany

  • MSD Sweden

    RECRUITING

    Stockholm, Sweden

  • Merck Sharp & Dohme Co. Ltd.

    RECRUITING

    Hod HaSharon, Israel

  • Merck Sharp & Dohme Lda.

    RECRUITING

    Paço de Arcos, Portugal

  • Merck Sharp & Dohme Ltd.

    RECRUITING

    London, United Kingdom

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