Non Hodgkin Lymphoma Clinical Trial

A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)

Summary

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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Between 6 months and <18 years of age on day of signing informed consent is documented.
Histologically- or cytologically-documented, locally-advanced, or metastatic solid malignancy or lymphoma that is incurable and has failed prior standard therapy, or for which no standard therapy exists, or for which no standard therapy is considered appropriate
Any number of prior treatment regimens
Tissue (or lymph node biopsy for rrcHL participants) available from an archival tissue sample or, if appropriate, a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
Measurable disease based on RECIST 1.1 (Or based on IWG [Cheson, 2007] [i.e., measurement must be >15 mm in longest diameter or >10 mm in short axis] for rrcHL participants)
Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
Lansky Play Scale ≥50 for participants from 6 months up to and including 16 years of age; or Karnofsky score ≥50 for participants >16 years of age
Adequate organ function
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication
Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who is abstinent from heterosexual intercourse or using contraception during the intervention period and for at least 120 days after the last dose of study intervention
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Demonstrate adequate organ function.

Exclusion Criteria:

Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation/randomization
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the date of allocation/randomization
Prior systemic anti-cancer therapy including investigational agent within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent
Prior radiotherapy within 2 weeks of start of study treatment
Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical carcinoma in situ) with potentially curative therapy, or in situ cervical cancer
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Tumor(s) involving the brain stem
Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Active infection requiring systemic therapy
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of study medication
Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, or any agent directed to another stimulatory or inhibitory T-cell receptor (eg, cytotoxic lymphocyte associated protein-4 [CTLA-4], OX-40, CD137)
Human immunodeficiency virus (HIV)
Hepatitis B or C
Known history of active tuberculosis (TB; Bacillus tuberculosis)
Received a live vaccine within 30 days of planned start of study medication
Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had an allogeneic hematopoietic transplant >5 years ago are eligible as long as there are no symptoms of Graft Versus Host Disease [GVHD].)
History or current evidence of any condition, therapy, or laboratory abnormality, or known severe hypersensitivity to any component or analog of the trial treatment, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study
Known psychiatric or substance abuse disorders that would interfere with the requirements of the study

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

370

Study ID:

NCT02332668

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 10 Locations for this study

See Locations Near You

Call for Information (Investigational Site 0019)
Aurora Colorado, 80045, United States
Call for Information (Investigational Site 0025)
Indianapolis Indiana, 46202, United States
Call for Information (Investigational Site 0026)
Boston Massachusetts, 02445, United States
Call for Information (Investigational Site 0031)
New York New York, 10032, United States
Call for Information (Investigational Site 0012)
Memphis Tennessee, 38105, United States
Call for Information (Investigational Site 0054)
Dallas Texas, 75235, United States
Call for Information (Investigational Site 0069)
Fort Worth Texas, 76104, United States
Call for Information (Investigational Site 0056)
Salt Lake City Utah, 84113, United States
Call for Information (Investigational Site 0014)
Seattle Washington, 98105, United States
Merck Sharp & Dohme
North Ryde , , Australia More Info
Australian Medical Information Centre
Contact
61 2 8988 8428
MSD Brasil
Sao Paulo , , Brazil More Info
MSD Online
Contact
0800 012 22 32
MSD France
Paris , , France More Info
Dominique Blazy
Contact
33 147548990
MSD Sharp & Dohme GmbH
Haar , , Germany More Info
German Medical Information Center
Contact
49 800 673 673 673
Merck Sharp & Dohme Co. Ltd.
Hod Hasharon , , Israel More Info
Gally Teper
Contact
972-9-9533310
MSD Italia S.r.l.
Rome , , Italy More Info
Barbara Capaccetti
Contact
39 06361911
MSD Korea LTD
Seoul , 4130, Korea, Republic of More Info
Jongho Ahn
Contact
82-2-331-2000 2015
MSD Sweden
Stockholm , , Sweden More Info
Tryggve Ljung
Contact
46 (0)70 545 28 66
Merck Sharp & Dohme Ltd.
Hoddesdon , , United Kingdom More Info
Natalie White
Contact
+44 (7795) 828757

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

370

Study ID:

NCT02332668

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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