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NCT03104699 · ClinicalTrials.gov registry record · Phase 1
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
A Phase 1 study of Cervical Cancer and Advanced Cancer, sponsored by Agenus.
- Completed
- Registry status
- Phase 1
- Development phase
- 211
- Enrollment target
- 20
- Study locations
NCT03104699: Completed Phase 1 study of Cervical Cancer and Advanced Cancer, sponsored by Agenus.
NCT03104699 is a Phase 1 study of Cervical Cancer and Advanced Cancer that has completed, run by Agenus. The registered enrollment target is 211 participants, below the 569-participant average among 144 other Cervical Cancer trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03104699, a Phase 1 study of Cervical Cancer and Advanced Cancer, has completed, sponsored by Agenus.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 211 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen.
Primary Outcome
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
Conditions Studied
Interventions
- DRUG AGEN2034
Study Locations (20)
California
- City of Hope - Duarte
- University of Southern California - Keck School of Medicine - Los Angeles
Florida
- Sylvester Comprehensive Cancer Center - Miami
- Florida Cancer Specialists & Research Institute - Sarasota
Rio Grande do Sul
- Hospital de Caridade de Ijuí - Ijuí
- Hospital Mãe de Deus - Porto Alegre
Arizona
- HonorHealth Research Institute - Scottsdale
Georgia
- Augusta Oncology - Augusta
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
Massachusetts
- Dana Farber Cancer Institute - Boston
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2017-04-11 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 1 |
What the finished NCT03104699 record still lists
NCT03104699 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 569-participant average among 144 other Cervical Cancer trials with a reported enrollment target (63% lower).
The record links to 2 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 1 intervention - of which AGEN2034 is the first listed.
NCT03104699 names 20 study sites across 17 states, led by California, Florida, Rio Grande do Sul.
Frequently Asked Questions
What is clinical trial NCT03104699 about?
NCT03104699 is a clinical study titled "A Study of AGEN2034 in Advanced Tumors and Cervical Cancer". This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed ...
What is the current status of trial NCT03104699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 211 participants. The study started on 2017-04-11. Estimated completion is 2022-06-15.
What conditions does trial NCT03104699 study?
This clinical trial studies the following conditions: Cervical Cancer, Advanced Cancer.
What interventions are being tested in trial NCT03104699?
The interventions under investigation include: AGEN2034 (DRUG).
Who is sponsoring clinical trial NCT03104699?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03104699 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03104699's enrollment target sits among peer trials
211 47th of 144 higher than 98 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer 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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