INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer
Public ClinicalTrials.gov record NCT04130854. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer, a Phase II Randomized Multi-center Trial With and Without APX005M, an Anti-CD40 Agonist
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.
Study identification
- NCT ID
- NCT04130854
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Interventions
- APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days Drug
- mFOLFOX and Radiation Therapy 5Gy x 5 days Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 23, 2020
- Primary completion
- Jan 29, 2026
- Completion
- Jan 29, 2026
- Last update posted
- May 5, 2026
2020 – 2026
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04130854, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04130854 live on ClinicalTrials.gov.