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Checkpoint Inhibitor

Pembrolizumab for Pediatric Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying a drug (pembrolizumab) to see if it can help to treat children who have cancer that has come back or does not respond to treatment.

Who is the study for?
This trial is for children aged 6 months to <18 years with advanced solid tumors or lymphoma, including melanoma and Hodgkin's lymphoma. They must have failed previous treatments or have no standard treatment options available. Participants need adequate organ function and a negative pregnancy test if applicable. Those with active brain metastases, current pneumonitis, recent live vaccines, HIV, hepatitis B/C, or severe allergies to pembrolizumab are excluded.Check my eligibility
What is being tested?
The study tests Pembrolizumab (MK-3475), an immunotherapy drug for pediatric cancer patients. It has two parts: the first part determines the safest dose for children while the second evaluates its effectiveness at that dose against various types of advanced cancers in kids.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs like lungs (pneumonitis) or intestines, skin reactions, liver problems, hormonal gland issues (like thyroid dysfunction), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not able to have children or I am using birth control and will not have heterosexual intercourse.
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My neuroblastoma shows up on a special scan.
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My cancer is advanced, cannot be cured with standard treatments, and has not responded to or is not suitable for any standard treatments.
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My organs are working well.
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My cancer is advanced melanoma or PD-L1-positive and has come back or not responded to treatment.
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I am a woman who can have children and have a recent negative pregnancy test.
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My organs are functioning well.
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I am between 6 months and 18 years old.
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I have had any number of previous treatments.
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I can provide a tissue sample from a previous or new biopsy.
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I am mostly active and can do most activities without help, regardless of my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Discontinuing Study Drug Due to AEs
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants with Dose-Limiting Toxicities (DLTs)
+3 more
Secondary outcome measures
Area Under the Concentration Curve (AUC) for Pembrolizumab
DOR per IWG 2007 (Cheson, 2007) Response by BICR Assessment (rrcHL Cohort)
DOR per IWG 2007 (Cheson, 2007) Response by Site Assessment (rrcHL Cohort)
+15 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

6Treatment groups
Experimental Treatment
Group I: rrcHLExperimental Treatment1 Intervention
Participants aged 3 years to <18 years with rrcHL receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
Group II: TMB-HExperimental Treatment1 Intervention
Participants aged 6 months to <18 years with tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
Group III: Solid Tumors and Other LymphomasExperimental Treatment1 Intervention
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.
Group IV: MelanomaExperimental Treatment1 Intervention
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 continues.
Group V: MSI-HExperimental Treatment1 Intervention
Participants aged 6 months to <18 years with microsatellite-instability-high (MSI-H) solid tumors receive pembrolizumab, starting dose 2 mg/kg (maximum dose 200 mg), IV Q3W.
Group VI: Adjuvant MelanomaExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,544 Total Patients Enrolled
31 Trials studying Melanoma
9,092 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCLead Sponsor
3,868 Previous Clinical Trials
5,051,629 Total Patients Enrolled
120 Trials studying Melanoma
21,312 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,061,690 Total Patients Enrolled
35 Trials studying Melanoma
10,934 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02332668 — Phase 1 & 2
Melanoma Research Study Groups: rrcHL, MSI-H, Adjuvant Melanoma, Melanoma, Solid Tumors and Other Lymphomas, TMB-H
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02332668 — Phase 1 & 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02332668 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this investigation?

"This study is seeking 370 participants between the age of 6 months and 17 who have been diagnosed with melanoma. In addition to this, potential patients must also adhere to these prerequisites: having incurable cancer that has not responded well or for which no standard therapy exists; access to an archived tissue sample or a newly obtained biopsy; Lansky Play Scale ≥50 (for those aged 16 and under) or Karnofsky score ≥50 (for ages over 16); prior treatment regimens are permitted."

Answered by AI

What conditions is Pembrolizumab used to treat?

"Pembrolizumab is frequently prescribed to combat malignant neoplasms, but it can also be taken for unresectable melanoma, microsatellite instability high and the development of disease symptoms after chemotherapy."

Answered by AI

Could you elucidate upon the research outcomes of previous experiments involving Pembrolizumab?

"Pembrolizumab was first trialed at City of Hope a decade ago and has since been the subject of 251 successful studies. As it stands, there are 961 ongoing trials with many being conducted in Dallas and Connecticut."

Answered by AI

Does the age limit exceed twenty years for participation in this medical experiment?

"This medical trial is seeking participants between the ages of 6 months and 17 years."

Answered by AI

How many research facilities are actively participating in this experiment?

"At this moment, 12 clinical sites are recruiting for the trial. These hubs span from Dallas to New Haven and Kirkland among other cities - thus it is advised that prospective participants select a nearby centre in order to minimise their travel needs should they choose to take part."

Answered by AI

What are the intended outcomes of this trial?

"This study, which will span up to 2 years and will be evaluated via the Number of Participants Experiencing Adverse Events (AEs), has 3 key objectives. These include: determining Disease Control Rate per RECIST 1.1 Site Assessment for MSIH and TMB-H cohorts respectively; calculating Area Under Conentration Curve (AUC) when administered as monotherapy; and measuring Duration Of Response by RECIST 1.1 Site Evaluation in Advanced Melanoma, Solid Tumors, or Other Lymphoma patients that meet criteria for either Complete Response (CR) or Partial Response (PR)."

Answered by AI

Are there still availabilities for participants in this research endeavor?

"Correct. According to clinicaltrials.gov, the trial which began accruing participants on March 18th 2015 is still recruiting patients and was last updated on November 23rd 2022."

Answered by AI

What is the total enrolment size for this research experiment?

"To fulfill the specified inclusion criteria, 370 individuals are required to partake in this trial. People can join from multiple locations including Call for Information (Investigational Site 0054) located in Dallas, Connecticut and Call for Information (Investigational Site 0020) based out of New Haven, Quebec."

Answered by AI
~103 spots leftby Oct 2027