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

  • STATUS
    Recruiting
  • End date
    Feb 13, 2027
  • participants needed
    440
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 16 May 2021
Investigator
Toll Free Number
Primary Contact
Arkansas Children's Hospital ( Site 0046) (2.3 mi away) Contact
+74 other location
cyclophosphamide
lymphoma
vincristine
prednisone
measurable disease
etoposide
doxorubicin
chemotherapy regimen
bleomycin
dacarbazine
vinblastine
classical hodgkin lymphoma

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.

Description

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.

Details
Condition Hodgkin's Disease, Lymphoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment cyclophosphamide, etoposide, Radiotherapy, Pembrolizumab, Bleomycin, vincristine, doxorubicin, dacarbazine, Radiotherapy (RT), Vinblastine, prednisone/prednisolone
Clinical Study IdentifierNCT03407144
SponsorMerck Sharp & Dohme Corp.
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Group 1: Must have newly diagnosed, pathologically confirmed 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
Has measurable disease per investigator assessment
Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period
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 treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment
Performance status: Lansky Play-Performance Scale 50 for children up to and including 16 years of age OR Karnofsky score 50 for participants >16 years of age
Has adequate organ function

Exclusion Criteria

Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment
Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%
Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study
Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents
Has received a live vaccine within 30 days prior to the first dose of pembrolizumab
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
Has a known additional malignancy that is progressing or requires active treatment
Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis
Has severe hypersensitivity (Grade 3) to any study therapies including any excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known history of active tuberculosis
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment
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