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

Status
Active
Cancer Type
Lymphoma
Neuroblastoma
Trial Phase
Phase I
Phase II
Eligibility
6 Months - 17 Years, Male and Female
Study Type
Treatment
NCT ID
NCT02332668
Protocol IDs
3475-051 (primary)
NCI-2015-00528
2014-002950-38
Study Sponsor
Merck Sharp & Dohme LLC

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.

Eligibility

  1. Between 6 months and <18 years of age on day of signing informed consent is documented.
  2. 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
  3. Any number of prior treatment regimens
  4. 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
  5. Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
  6. 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)
  7. Participants with neuroblastoma with only metaiodobenzylguanidine (MIBG)-positive evaluable disease may be enrolled
  8. 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
  9. Adequate organ function
  10. Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours before the first dose of study medication
  11. 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
  12. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  13. Demonstrate adequate organ function.
**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.
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