CompletedPhase 2

INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer

United States58 participantsStarted 2020-04-24

Plain-language summary

Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. At least 18 years of age. Both men and women and members of all races and ethnic groups will be included.
✓. Willing and able to provide written informed consent
✓. Pathologic diagnosis of rectal adenocarcinoma
✓. Stage III or Stage II with at least 1 of the following high-risk features:
✓. No prior treatment for rectal adenocarcinoma
✓. Eastern Cooperative Group (ECOG) performance status of 0-1.
✓. Laboratory values supporting acceptable organ and marrow function within 21 days of eligibility confirmation. Defined as follows:
✓. Female participants of childbearing potential (FOCBP) must have a negative serum or urine pregnancy test (per institutional standards) within 72 hours prior to the start of study drug.

Exclusion criteria

✕. Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT or PET
✕. Prior RT to the pelvis.
✕. Uncontrolled comorbid illness or condition including an active infection, congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements.
✕. Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
✕. Any positive history for HIV/AIDS, HTLV, hepatitis B or hepatitis C virus indicating acute or chronic infection.
✕. Any active known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
✕. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
✕. Malignancy in the past 3 years that required active treatment except locally curable cancers or cancers deemed by the treating physicians to not impact the subject's survival duration.

What they're measuring

Pathological Complete Response Rate

Timeframe: At time of surgery

Trial details

NCT IDNCT04130854

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-30

View on ClinicalTrials.gov More Locally Advanced Rectal Adenocarcinoma trials