Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Condition(s) studied
Investigational drug(s) / intervention(s)
pembrolizumab: 2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W
doxorubicin: 25 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 40 mg/m\^2 IV on Days 1 and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 25 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)
vinblastine: 6 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 6 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)
dacarbazine: 375 mg/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 375 mg/m\^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1) 250 mg/m\^2 IV on Days 1 to 3 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)
cyclophosphamide: 500 mg/m\^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)
vincristine: 1.5 mg/m\^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 1.5 mg/m\^2 IV with maximum single dose 2 mg on Days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)
prednisone/prednisolone: 60 mg/m\^2/day orally divided in 3 doses on Days 1 to 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 40 mg/m\^2/day orally divided in 3 doses on Days 1 to 15 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)
bleomycin: 10 units/m\^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)
etoposide: 125 mg/m\^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
Radiotherapy (RT): RT administered daily, dose dependent on randomization group and disease response.
Study summary
This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR) — Up to approximately 8 years
ORR is defined as the percentage of SER participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) using IWG revised response criteria and determined by BICR. The ORR will be estimated by risk group in SER participants.
Trial sites (93)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Alabama ( Site 0023) | Birmingham | Alabama | |
| Phoenix Childrens Hospital ( Site 0034) | Phoenix | Arizona | |
| Arkansas Children's Hospital ( Site 0046) | Little Rock | Arkansas | |
| Kaiser - Orange County ( Site 0084) | Anaheim | California | |
| Kaiser Permanente ( Site 0082) | Downey | California | |
| Kaiser - Fontana ( Site 0083) | Fontana | California | |
| MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si | Long Beach | California | |
| Kaiser Permanente Downey Medical Center ( Site 0024) | Los Angeles | California | |
| Kaiser Permanente - Oakland ( Site 0047) | Oakland | California | |
| Kaiser Permanente - Roseville ( Site 0080) | Roseville | California | |
| Kaiser Permanente - Santa Clara ( Site 0079) | Santa Clara | California | |
| Children's Hospital - Colorado ( Site 0028) | Aurora | Colorado | |
| Connecticut Children's Medical Center ( Site 0045) | Hartford | Connecticut | |
| Yale Cancer Center ( Site 0061) | New Haven | Connecticut | |
| Children's National Medical Center ( Site 0090) | Washington D.C. | District of Columbia | |
| University of Florida ( Site 0051) | Gainesville | Florida | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048) | Hollywood | Florida | |
| Arnold Palmer Hospital ( Site 0065) | Orlando | Florida | |
| Children's Healthcare of Atlanta at Egleston ( Site 0033) | Atlanta | Georgia | |
| University of Chicago ( Site 0066) | Chicago | Illinois | |
| Riley Hospital for Children ( Site 0091) | Indianapolis | Indiana | |
| University of Kentucky Markey Cancer Center ( Site 0057) | Lexington | Kentucky | |
| University of Louisville-Norton Children's Hospital ( Site 0059) | Louisville | Kentucky | |
| Johns Hopkins University ( Site 0025) | Baltimore | Maryland | |
| Children's Hospital of Michigan ( Site 0056) | Detroit | Michigan | |
| Karmanos Cancer Institute ( Site 0002) | Detroit | Michigan | |
| Children's Hospitals and Clinics of Minnesota ( Site 0036) | Minneapolis | Minnesota | |
| St. Louis Children's Hospital ( Site 0038) | St Louis | Missouri | |
| Alliance for Childhood Diseases ( Site 0064) | Las Vegas | Nevada | |
| Hackensack University Medical Center ( Site 0026) | Hackensack | New Jersey | |
| Rutgers Cancer Institute of New Jersey ( Site 0027) | New Brunswick | New Jersey | |
| Roswell Park Cancer Institute ( Site 0040) | Buffalo | New York | |
| Cohen Children's Medical Center of New York ( Site 0052) | New Hyde Park | New York | |
| Columbia University/Herbert Irving Cancer Center ( Site 0063) | New York | New York | |
| Memorial Sloan Kettering Cancer Center ( Site 0060) | New York | New York | |
| Weill Cornell Medicine ( Site 0032) | New York | New York | |
| UNC Lineberger Comprehensive Cancer ( Site 0044) | Chapel Hill | North Carolina | |
| Cincinnati Children's Hospital Medical Center ( Site 0035) | Cincinnati | Ohio | |
| Nationwide Children's Hospital ( Site 0037) | Columbus | Ohio | |
| St. Francis Hospital Cancer Center ( Site 0001) | Greenville | South Carolina |
+ 53 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03407144 on ClinicalTrials.gov ↗ ← All trials in Italy