INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04130854|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2019
Last Update Posted : July 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Rectal Adenocarcinoma||Drug: APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days Drug: mFOLFOX and Radiation Therapy 5Gy x 5 days||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||November 1, 2023|
|Estimated Study Completion Date :||November 1, 2023|
Experimental: APX005M on day 3 of RT & day 3 of cycles 1-5 of mFOLFOX
On Day 3 of Cycles 1-5 of each mFOLFOX treatment, participants will receive another dose of APX005M. The sequence of administration of APX005M in combination with mFOLFOX. In Cycle 6, participants will receive only mFOLFOX. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.
Drug: APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days
Active Comparator: Radiation Therapy 5Gy x 5 days, mFOLFOX
Participants randomized to Arm 2 will receive short-course RT and mFOLFOX regimen, except that participants will not receive any of the study drug. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.
Drug: mFOLFOX and Radiation Therapy 5Gy x 5 days
- Pathological Complete Response Rate [ Time Frame: At time of surgery ]The primary objective of this study is to determine the pathologic complete response (pCR) rate of the combined treatment modality.
- Overall Survival [ Time Frame: 3 years ]To evaluate overall survival (OS), defined as the time between date of randomization and the date of death due to any cause.
- Toxicity analysis [ Time Frame: 3 years ]To evaluate toxicity analysis comparing the experimental from the standard arm measured according to CTCAE v5.0.
- Disease free survival [ Time Frame: 3 years ]To evaluate the disease free survival (DFS) and patterns of failure at three years. DFS is defined as the time between the date of definitive surgery and the first date of documented disease progression or death.
- Exploratory Immunological Response [ Time Frame: 3 years ]To evaluate the immunologic response surrogates for patients tissue is obtained.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130854
|United States, Arizona|
|The University of Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|Wake Forest Baptist Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Todd Aguilera, MD||UT Southwestern Medical Center|