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Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

Status
Closed
Cancer Type
Hodgkin Lymphoma
Trial Phase
Phase II
Eligibility
3 - 25 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03407144
Protocol IDs
3475-667 (primary)
MK-3475-667
2017-001123-53
NCI-2018-00389
Study Sponsor
Merck Sharp & Dohme LLC

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.

Objectives

Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky
disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB,
IIIB, IVA and IVB.

Eligibility

  1. Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB
  2. Has measurable disease per investigator assessment.
  3. Male participants are eligible to participate if they agree to the following during the intervention period: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic.
  4. Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
  5. Performance status: Lansky Play-Performance Scale =50 for children up to 16 years of age OR Karnofsky score =50 for participants = 16 years of age
  6. Has adequate organ function

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.