Study on Combination Immunotherapy for Advanced Cancers, Including HPV-Related, Small Bowel, and Colon Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04708470

Provider View

This clinical trial is testing a new combination of drugs to see if they can safely and effectively shrink tumors in adults with advanced cancers, including those linked to HPV and certain types of bowel and colon cancers.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced cancers that are often hard to treat, such as those associated with HPV and some colon cancers. The treatment combines three drugs: entinostat, NHS-IL12, and bintrafusp alfa. The main goals are to find a safe dose and to see if this combination can help shrink tumors in adults aged 18 and older with these types of cancers.

Description

Researchers are testing a new combination of drugs to treat advanced cancers, including those linked to HPV and certain bowel and colon cancers. These cancers often don't respond well to current treatments. The study involves three drugs: entinostat, NHS-IL12, and bintrafusp alfa, which are given together to see if they can work better than current treatments.

The study is divided into two phases. Phase I aims to find a safe dose of the drug combination. Phase II will test how well the treatment works in shrinking tumors. Participants will receive the treatment in 28-day cycles, with regular check-ups and tests to monitor their health and the treatment's effects.

Participants will be screened with medical exams, imaging scans, and other tests to ensure they are eligible. The treatment involves receiving the drugs through an IV and injections, as well as taking a pill. Participants will keep a diary of their medication use and will be followed up for two years to monitor their health.

The study aims to provide new insights into whether this combination of drugs can offer better outcomes for patients with these challenging cancers.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with advanced cancers linked to HPV or certain bowel and colon cancers.
  • Must have received previous standard treatments unless they chose not to after being informed.
  • Must have measurable cancer that can be tracked.
  • Good overall health with specific blood and organ function levels.
  • Women and men must agree to use effective birth control during and after the study.
  • HIV, Hepatitis B, and C positive individuals can participate if their viral loads are undetectable and they meet other health criteria.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent treatment with other investigational drugs, chemotherapy, or immunotherapy within 28 days before joining the study.
  • Recent major surgery or live vaccines within 28-30 days before joining.
  • Active brain or central nervous system cancer that hasn't been stable for at least a month after treatment.
  • Active autoimmune diseases that could worsen with the study treatment, except for mild conditions like controlled diabetes or thyroid issues.
  • Use of systemic steroids or immunosuppressive drugs unless they are at low doses.
  • Serious health conditions that could increase risks with the study treatment.
  • Significant fluid buildup in the body or recent serious bleeding events.
  • History of another cancer within the last three years, except for certain non-threatening types.
  • Known severe allergies to similar drugs.
  • Pregnant or breastfeeding women due to potential risks to the baby.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.