Conditions
Classical Hodgkin Lymphoma, Lymphoma, Melanoma, Microsatellite-instability-high Solid Tumor, Solid Tumor
Clinical Trials
This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer:
advanced melanoma (6 months to <18 years of age),
advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age),
relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or
advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or
advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age), or
with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in children 12 years to <18 years of age
Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D.
The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts.
With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.
NATIONAL TRIAL REFERENCE NUMBER
NCT02332668
When you talk with your doctor or clinical trial team member, please have the trial identifier number available.
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Classical Hodgkin Lymphoma, Lymphoma, Melanoma, Microsatellite-instability-high Solid Tumor, Solid Tumor
Age Range
6 Months - 17 Years (Child)
Sex
All
Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.
In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.
If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.
If you are considering joining a clinical trial, first learn as much as you can about:
Talk to your doctor about the clinical trial before you decide to join.
Read our “What to Consider” page for more questions to ask and think about