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NCT03445858 · ClinicalTrials.gov registry record · Early Phase 1
Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults
A Early Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT03445858: Completed Early Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03445858 is a Early Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 22 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03445858, a Early Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This pilot study is designed to assess the safety, tolerability, and preliminary anti-tumor activity of the combination of pembrolizumab, decitabine and fixed-dose hypofractionated index site radiotherapy in pediatric and young adult patients with relapsed, refractory or progressive non-primary CNS solid tumors and lymphomas. Primary Objectives * To determine the feasibility of administering pembrolizumab in combination with decitabine and hypofractionated index lesion radiation * To identify the treatment related toxicity and tolerability of the combination of decitabine and pembrolizumab with hypofractionated index lesion radiation Secondary Objective To preliminarily define the anti-tumor efficacy of the combination of pembrolizumab, decitabine and hypofractionated index lesion radiation in patients with relapsed, refractory, or progressive non-CNS solid tumors and lymphomas using overall response rate (CR + PR) by irRECIST after 2 cycles of therapy. Exploratory Objectives To profile the kinetics of the immune response and to correlate with promotor methylation changes, nuclear imaging, stool microbiota diversity, and tumor associated antigen immune responses.
Primary Outcome
Incidence of number of patients who experience a DLT
Interventions
- DRUG Pembrolizumab
- DRUG Decitabine
- RADIATION Hypofractionated Index Site Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2023-11-07 |
| Phase | Early Phase 1 |
What the finished NCT03445858 record still lists
NCT03445858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03445858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03445858 about?
NCT03445858 is a clinical study titled "Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults". This pilot study is designed to assess the safety, tolerability, and preliminary anti-tumor activity of the combination of pembrolizumab, decitabine and fixed-dose hypofractionated index site radiotherapy in pediatric and young adult patients with relapsed, refractory or progressive non-primary CNS ...
What is the current status of trial NCT03445858?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2018-02-12. Estimated completion is 2023-11-07.
What interventions are being tested in trial NCT03445858?
The interventions under investigation include: Pembrolizumab (DRUG), Decitabine (DRUG), Hypofractionated Index Site Radiation (RADIATION).
Who is sponsoring clinical trial NCT03445858?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03445858's enrollment target sits among peer trials
22 1104th of 2000 higher than 872 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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