Phase I/II Study of Combination Immunotherapy for Metastatic Colorectal Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06149481

Provider View

This clinical trial is testing a new combination of up to four experimental drugs to treat metastatic colorectal cancer (mCRC), which is cancer that has spread to other parts of the body. The study aims to see if these drugs can help control the disease and improve survival rates.

Patient Parameters

Program Overview

Each year, many people in the U.S. are diagnosed with colorectal cancer that has spread to other organs, known as metastatic colorectal cancer (mCRC). This study is testing a combination of four experimental drugs—retifanlimab, TriAdeno vaccine, N-803, and SX-682—to see if they can help treat mCRC. Participants will be screened with exams and tests, and if eligible, will receive either three or four of these drugs. The treatment involves regular injections and pills over a period of up to two years, with follow-up for three more years.

Description

This study is exploring a new treatment for metastatic colorectal cancer (mCRC), which is cancer that has spread beyond the colon. The treatment involves a combination of four experimental drugs: retifanlimab, TriAdeno vaccine, N-803, and SX-682. These drugs work together to boost the immune system's ability to fight cancer.

Retifanlimab is given through an IV every four weeks, while N-803 is injected under the skin of the abdomen every four weeks. The TriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for the first three doses, then once every three months. Some participants will also take SX-682, a pill taken twice a day at home for about three weeks each month.

The study will last up to two years, with follow-up calls or emails for three more years. Participants will have two tumor biopsies, one at the start and another about eight weeks later, and will receive $500 for each biopsy. The study aims to determine the safety and effectiveness of this combination treatment in improving outcomes for people with mCRC.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older with metastatic colorectal cancer.
  • Must have received or been ineligible for standard treatments, or refused them.
  • Must have measurable disease according to specific medical criteria.
  • Must have good overall health with a performance status score of 2 or less.
  • Must have adequate organ function as determined by specific blood tests.
  • Must be willing to undergo mandatory tumor biopsies.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for six months after.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • Recent treatment with investigational drugs, chemotherapy, or radiotherapy.
  • Active autoimmune disease requiring high doses of steroids.
  • Active infections requiring treatment within eight days before starting the study.
  • History of organ transplant or severe allergic reactions to similar drugs.
  • Recent receipt of a live vaccine.
  • Uncontrolled illness that would interfere with study participation.
  • Pregnant or breastfeeding women.

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