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NCT02636036 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
A Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by Akamis Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 6
- Study locations
NCT02636036: Completed Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by Akamis Bio.
NCT02636036 is a Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck that has completed, run by Akamis Bio. The registered enrollment target is 51 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02636036, a Phase 1 study of Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by Akamis Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.
Primary Outcome
Review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death
Conditions Studied
Interventions
- BIOLOGICAL nivolumab
- BIOLOGICAL enadenotucirev
Study Locations (6)
California
- City of Hope Comprehensive Cancer Center, 1500 E Duarte Str. - Duarte
- UCLA Medical Center, 10945 Le Conte Ave, Ste. 3360 - Santa Monica
Arizona
- University of Arizona Cancer Center, 1515 North Campbell Ave. - Tucson
Indiana
- Horizon Oncology Research, 1345 Unity Place, Suite 365 - Lafayette
Michigan
- Henry Ford Hospital, 2799 West Grand Blvd. - Detroit
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2016-01-25 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 1 |
What the finished NCT02636036 record still lists
NCT02636036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which nivolumab is the first listed.
NCT02636036 lists 6 locations in 5 states (California, Arizona, Indiana).
Frequently Asked Questions
What is clinical trial NCT02636036 about?
NCT02636036 is a clinical study titled "Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors". This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.
What is the current status of trial NCT02636036?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2016-01-25. Estimated completion is 2021-10-08.
What conditions does trial NCT02636036 study?
This clinical trial studies the following conditions: Colorectal Cancer, Squamous Cell Carcinoma of the Head and Neck, Epithelial Tumor.
What interventions are being tested in trial NCT02636036?
The interventions under investigation include: nivolumab (BIOLOGICAL), enadenotucirev (BIOLOGICAL).
Who is sponsoring clinical trial NCT02636036?
This trial is sponsored by Akamis Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02636036 being conducted?
This trial has 6 study locations across Arizona, California, Indiana, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02636036's enrollment target sits among peer trials
51 269th of 381 higher than 111 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal 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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