Immunotherapy + Chemoradiation for Rectal Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byTodd Aguilera, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

Eligibility Criteria

Adults diagnosed with locally advanced rectal adenocarcinoma who haven't had previous treatments for it. They must be in good physical condition (ECOG 0-1) and have certain high-risk features or stage II/III cancer. Participants need proper organ and marrow function, not be pregnant or nursing, agree to use contraception, and can't have HIV/AIDS, hepatitis B/C, other cancers within the last 3 years (with exceptions), serious illnesses that could affect study participation, known autoimmune diseases (with exceptions), recent live vaccines, lung disease history, or prior specific immunotherapies.

Inclusion Criteria

FOCBP must agree to use highly-effective method(s) of contraception (Appendix A) during the study and for 90 days after the last dose of study drugs.

I am fully active or can carry out light work.

I have been diagnosed with rectal cancer.

+7 more

Exclusion Criteria

I haven't had cancer treatment in the last 3 years, except for easily treatable types.

I have not received a live vaccine in the last 6 weeks.

I have had radiation therapy to my pelvic area before.

+11 more

Participant Groups

The trial is testing if adding APX005M to standard chemotherapy (mFOLFOX) plus radiation therapy improves complete response rates in rectal cancer patients compared to just mFOLFOX with radiation. The goal is to see which treatment better eliminates all signs of cancer before surgery.

2Treatment groups

Experimental Treatment

Active Control

Group I: APX005M on day 3 of RT & day 3 of cycles 1-5 of mFOLFOXExperimental Treatment1 Intervention

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.

Group II: Radiation Therapy 5Gy x 5 days, mFOLFOXActive Control1 Intervention

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.