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NCT02332668 · ClinicalTrials.gov registry record · Phase 1
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)
A Phase 1 study of Lymphoma and Melanoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 370
- Enrollment target
- 17
- Study locations
NCT02332668: Recruiting Phase 1 study of Lymphoma and Melanoma, sponsored by Merck Sharp & Dohme.
NCT02332668 is a Phase 1 study of Lymphoma and Melanoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 370 participants, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (23% lower). The trial reports 17 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02332668, a Phase 1 study of Lymphoma and Melanoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 370 participants
- Enrollment target
- 17
- Study locations
Study Summary
Researchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these: * Advanced, which means cancer spread in the body or cannot be removed with surgery * Relapsed, which means cancer has come back after it had responded to previous treatment (responded means it stopped growing, gets smaller, or disappeared) * Refractory, which means cancer did not respond to previous treatment Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Researchers want to learn if different doses of pembrolizumab can cause at least 1 of the types of cancer to get smaller or go away. With Amendment 8, enrolment of participants with solid tumours and participants 6 months to under 12 years old with melanoma were closed. Enrolment of participants 12-18 years old with melanoma continues. Enrolment of participants who have tumours with specific traits (microsatellite-instability-high (MSI-H), and tumour-mutational burden-high ≥10 mutation/Mb (TMB-H)) also continues.
Primary Outcome
The ORR is assessed by RECIST 1.1 per site assessment. The ORR is defined as the percentage of participants who have a response (complete response, CR or partial response, PR) prior to disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
Study Locations (17)
Other
- MSD Brasil - São Paulo
- MSD France - Paris
- MSD Sharp & Dohme GmbH - München
- Merck Sharp & Dohme Co. Ltd. - Hod HaSharon
- MSD Italia S.r.l. - Rome
- Merck Sharp & Dohme BV - Haarlem
- Merck Sharp & Dohme Lda. - Paço de Arcos
- MSD Korea LTD - Seoul
- MSD Sweden - Stockholm
- Merck Sharp & Dohme Ltd. - London
Colorado
- Call for Information (Investigational Site 0019) - Aurora
Massachusetts
- Call for Information (Investigational Site 0026) - Boston
New York
- Call for Information (Investigational Site 0031) - New York
North Dakota
- Call for Information (Investigational Site 0070) - Fargo
Ohio
- Call for Information (Investigational Site 0032) - Cincinnati
South Dakota
- Call for Information (Investigational Site 0071) - Sioux Falls
Texas
- Call for Information (Investigational Site 0054) - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2015-03-18 |
| Est. Completion | 2027-10-25 |
| Phase | Phase 1 |
What NCT02332668 shows while recruiting
NCT02332668 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (23% lower).
The record links to 5 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT02332668 lists 17 locations in 8 states (Other, Colorado, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT02332668 about?
NCT02332668 is a clinical study titled "A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)". Researchers are looking for new ways to treat children with different types of melanoma (skin cancer), solid tumors, and lymphomas (blood cancers) that are any of these: * Advanced, which means cancer spread in the body or cannot be removed with surgery * Relapsed, which means cancer has come back ...
What is the current status of trial NCT02332668?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2015-03-18. Estimated completion is 2027-10-25.
What conditions does trial NCT02332668 study?
This clinical trial studies the following conditions: Lymphoma, Melanoma, Solid Tumor, Classical Hodgkin Lymphoma, Microsatellite-instability-high Solid Tumor.
What interventions are being tested in trial NCT02332668?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02332668?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02332668 being conducted?
This trial has 17 study locations across Colorado, Massachusetts, New York, North Dakota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02332668's enrollment target sits among peer trials
370 25th of 299 higher than 275 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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