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Chemotherapy

Immunotherapy + Chemoradiation for Rectal Cancer

Phase 2

Waitlist Available

Led By Todd Aguilera, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Group (ECOG) performance status of 0-1.

Pathologic diagnosis of rectal adenocarcinoma

Must not have

Prior RT to the pelvis.

Known history of interstitial lung disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new cancer drug can help patients with rectal adenocarcinoma by giving them a complete pathologic response.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in different body parts due to APX005M; typical chemo-related issues like nausea, fatigue, blood cell count changes from mFOLFOX; and skin irritation from radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have been diagnosed with rectal cancer.

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I am a woman capable of becoming pregnant and have not been surgically sterilized or menopause-free for over a year without a medical reason.

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My rectal cancer is advanced but hasn't been treated yet.

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I am a woman who can have children and have a recent negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my pelvic area before.

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I have a history of interstitial lung disease.

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I have not received treatments targeting specific immune checkpoints.

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I am not currently taking any experimental drugs, cancer treatments, or immunosuppressants.

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My cancer has spread to distant lymph nodes or other areas, confirmed by scans.

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I have a history of HIV/AIDS, HTLV, hepatitis B, or hepatitis C.

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I do not have any severe illnesses like heart failure or serious infections that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological Complete Response Rate

Secondary study objectives

Disease free survival

Overall Survival

Toxicity analysis

Other study objectives

Exploratory Immunological Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 12Eligibility criteria met