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NCT04761198 · ClinicalTrials.gov registry record · Phase 1
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
A Phase 1 study, sponsored by Mereo BioPharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT04761198: Completed Phase 1 study, sponsored by Mereo BioPharma.
NCT04761198 is a Phase 1 study that has completed, run by Mereo BioPharma. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04761198, a Phase 1 study, has completed, sponsored by Mereo BioPharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 milligrams \[mg\] every 2 weeks).
Primary Outcome
The ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. CR: Disappearance of all target or non-target lesions and normalization of tumor marker level. Any pathological lymph node (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the ba
Interventions
- DRUG Nivolumab
- DRUG Etigilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-03-23 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 1 |
What the finished NCT04761198 record still lists
NCT04761198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04761198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04761198 about?
NCT04761198 is a clinical study titled "A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors". This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to rec...
What is the current status of trial NCT04761198?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2021-03-23. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT04761198?
The interventions under investigation include: Nivolumab (DRUG), Etigilimab (DRUG).
Who is sponsoring clinical trial NCT04761198?
This trial is sponsored by Mereo BioPharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04761198's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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