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OncoMatch/Clinical Trials/NCT02332668

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

Is NCT02332668 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Pembrolizumab for melanoma.

Phase 1/2RecruitingMerck Sharp & Dohme LLCNCT02332668Data as of Jun 2026Location: International · 11 countries

Treatment: PembrolizumabResearchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these: * Advanced, which means cancer spread in the body or cannot be removed with surgery * Relapsed, which means cancer has come back after it had responded to previous treatment (responded means it stopped growing, gets smaller, or disappeared) * Refractory, which means cancer did not respond to previous treatment Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at least 1 of the types of cancer to get smaller or go away. With Amendment 8, enrolment of participants with solid tumours and participants 6 months to under 12 years old with melanoma were closed. Enrolment of participants 12-18 years old with melanoma continues. Enrolment of participants who have tumours with specific traits (microsatellite-instability-high (MSI-H), and tumour-mutational burden-high ≥10 mutation/Mb (TMB-H)) also continues.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Cancer type

Melanoma

Hodgkin Lymphoma

Tumor Agnostic

Biomarker criteria

Required: PD-L1 (CD274) positive (positive)

Disease stage

Required: Stage III, IV

locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy

Demographics

Ages 0–17

Prior therapy

Must have received: standard therapy

has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate

Cannot have received: anti-PD-1 therapy

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)

Cannot have received: systemic anti-cancer therapy

Exception: within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent

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

Cannot have received: radiotherapy

Exception: within 2 weeks of start of study treatment

Prior radiotherapy within 2 weeks of start of study treatment

Cannot have received: investigational agent

Exception: within 4 weeks of the date of allocation/randomization

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

Lab requirements

Blood counts

adequate organ function

Kidney function

adequate organ function

Liver function

adequate organ function

Demonstrate adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Call for Information (Investigational Site 0019) · Aurora, Colorado
  • Call for Information (Investigational Site 0026) · Boston, Massachusetts
  • Call for Information (Investigational Site 0031) · New York, New York
  • Call for Information (Investigational Site 0070) · Fargo, North Dakota
  • Call for Information (Investigational Site 0032) · Cincinnati, Ohio

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT02332668 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-PD-1 therapy, systemic anti-cancer therapy, radiotherapy disqualifies patients from enrollment.

Does this trial require CD274?

Yes, CD274 positive is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Is there an age limit?

Yes. Patients must be 17 years or younger and at least 0 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify