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

Conditions

• Classical Hodgkin Lymphoma
• Lymphoma
• Melanoma
• Microsatellite-instability-high Solid Tumor
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

6 Months - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  IV infusion

Study Details

Researchers 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, enrollment of participants with solid tumors and participants 6 months to under 12 years old with melanoma were closed. With Amendment 13, enrollment was closed for participants with relapsed refractory classical Hodgkin lymphoma (rrCHL), microsatellite instabilty-high (MSI-H) solid tumors, tumor-mutational burden-high (TMB-H) solid tumors, and participants 12 years old to \<18 years old with advanced melanoma.

Key Dates

Start date

Mar 19, 2015

Status verified

May 2026

Primary completion

Feb 2, 2028

Completion

Feb 2, 2028

Study Design

Enrollment

370 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Melanoma
  Participants aged 6 months to \<18 years with melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W). Enrollment of participants aged 6 months to \<12 years with melanoma was closed with Amendment 8. Enrollment of participants aged ≥12 years to ≤18 years with melanoma closed with Amendment 13.
• Experimental: Solid Tumors and Other Lymphomas
  Participants aged 6 months to \<18 years with solid tumors and other lymphomas receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Initial enrollment limited to programmed death-ligand 1 (PD-L1)-positive participants. PD-L1-negative participants may enroll if responses are observed. Enrollment of participants with solid tumors and other lymphomas was closed with Amendment 8.
• Experimental: Relapsed Refractory Classical Hodgkin Lymphoma (rrcHL)
  Participants aged 3 years to \<18 years with rrcHL receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Enrollment of participants with rrcHL was closed with Amendment 13.
• Experimental: Microsatellite Instability-High (MSI-H)
  Participants aged 6 months to \<18 years with MSI-H solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Enrollment of participants with MSI-H solid tumors was closed with Amendment 13.
• Experimental: Tumor Mutational Burden-High (TMB-H)
  Participants aged 6 months to \<18 years with TMB-H ≥10 mutation/Mb solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W. Enrollment of participants with TMB-H solid tumors was closed with Amendment 13.
• Experimental: Adjuvant Melanoma
  Participants aged 12 years to \<18 years with resected high-risk Stage IIB, IIC, III, or IV melanoma receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), intravenously (IV) once every 3 weeks (Q3W).

Primary Outcome Measure

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors and Other Lymphoma Version 1.1 (RECIST 1.1) per Site Assessment (Each Disease Indication Evaluated Separately) [ Time Frame: Up to 2 years ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (7)

Find similar trials in Aurora, CO

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