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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

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

Must not have

Active infection requiring systemic therapy

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 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 cancer is advanced melanoma or PD-L1-positive and has come back or not responded to treatment.

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I am between 6 months and 18 years old.

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I am mostly active and can do most activities without help, regardless of my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for an infection.

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I have had pneumonitis treated with steroids or have it now.

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I have previously been treated with specific immune therapy drugs.

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I have hepatitis B or C.

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I have not received a live vaccine in the last 30 days.

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I have an active tuberculosis infection.

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I haven't had cancer treatment or clinical trial drugs in the last 2 weeks.

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I have cancer that has spread to my brain or spinal cord.

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I have not had radiotherapy in the last 2 weeks.

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I don't have any health issues or allergies that would affect my participation in the study.

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My cancer affects the brain stem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

0 / 16Eligibility criteria met