Conditions
Classical Hodgkin Lymphoma, Lymphoma, Melanoma, Microsatellite-instability-high Solid Tumor, Solid Tumor
Trial Purpose
This is a two-part study of pembrolizumab (MK-3475) in paediatric 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 tumour 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 tumours (6 months to <18 years of age) or
- advanced relapsed or refractory tumour-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumours (6 months 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 paediatric 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 tumour or other lymphoma; advanced, relapsed or refractory MSI-H solid tumour; 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, enrolment of participants with solid tumours and participants aged 6 months to <12 years with melanoma were closed. Enrolment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrolment of participants with MSI-H and TMB-H solid tumours also continues.
NATIONAL TRIAL REFERENCE NUMBER
NCT02332668
EudraCT
2014-002950-38
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
Resources
Eligibility
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.
Age Range
6 Months - 17 Years (Child)
Sex
All
About The Trial
Trial Phase
Trial Phase 1
Tests the medicine or vaccine in a small group of 20 to 100 volunteers who are usually healthy, but not always. The trial often takes place in a hospital.
Trial Phase 2
Tests the medicine or vaccine in approximately 100 to 500 volunteers. In the case of medicines, volunteers usually have the disease or condition the investigational medicine is designed to treat. In vaccine studies, the volunteers are usually healthy.
Trial start and end dates
- Actual study start date 18 March 2015
- Estimated primary completion date 6 May 2025
- Estimated study completion date 6 May 2025
Trial locations
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.
What can you do next?
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.
Taking part in a clinical trial is an important decision
If you are considering joining a clinical trial, first learn as much as you can about:
- The investigational treatment that is being studied
- What the risks and possible benefits are for participants
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