Recruiting
Phase 1
Phase 2

Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT02332668

Conditions

Melanoma

Lymphoma

Solid Tumor

Classical Hodgkin Lymphoma

Microsatellite-instability-high Solid Tumor

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Melanoma

Lymphoma

Solid Tumor

Classical Hodgkin Lymphoma

Microsatellite-instability-high Solid Tumor

Study ID

NCT02332668

Start date

Mar 19, 2015

Status verified date

Jul, 2026

Completion date

Feb 2, 2028

Anticipated

Primary completion date

Feb 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

370 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Pembrolizumab

IV infusion

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 ]
  • ORR by RECIST 1.1 per Site Assessment for MSI-H or TMBH Solid Tumors (Each Cohort Evaluated Separately) [ Time Frame: Up to 2 years ]
  • ORR by International Working Group (IWG) Response Criteria (Cheson, 2007) per Blinded Independent Central Review (BICR) Assessment for rrcHL Cohort [ Time Frame: Up to approximately 2 years ]
  • Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Up to 21 days) ]
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 27 months ]
  • Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Call for Information (Investigational Site 0019)

Recruiting

Aurora, Colorado, United States, 80045

Call for Information (Investigational Site 0024)

Recruiting

Chicago, Illinois, United States, 60637

Call for Information (Investigational Site 0026)

Recruiting

Boston, Massachusetts, United States, 02445

Call for Information (Investigational Site 0031)

Recruiting

New York, New York, United States, 10032

Call for Information (Investigational Site 0070)

Recruiting

Fargo, North Dakota, United States, 58102

Call for Information (Investigational Site 0071)

Recruiting

Sioux Falls, South Dakota, United States, 57117

Call for Information (Investigational Site 0054)

Recruiting

Dallas, Texas, United States, 75235

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • PD1
  • PD-1
  • PDL1
  • PD-L1
  • cHL
  • MSI-H

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-06.