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NCT04879849 · ClinicalTrials.gov registry record · Phase 1
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT04879849: Completed Phase 1 study, sponsored by Takeda.
NCT04879849 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04879849, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it. Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.
Primary Outcome
AE: any untoward medical occurrence in participants administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical
Interventions
- DRUG Pembrolizumab
- DRUG TAK-676
- RADIATION Image-guided radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-09-09 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 1 |
What the finished NCT04879849 record still lists
NCT04879849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04879849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04879849 about?
NCT04879849 is a clinical study titled "A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers". In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after t...
What is the current status of trial NCT04879849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2021-09-09. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT04879849?
The interventions under investigation include: Pembrolizumab (DRUG), TAK-676 (DRUG), Image-guided radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT04879849?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04879849's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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