RECTIFY-1: Study on Botensilimab and Balstilimab Before Surgery for Early Rectal Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT07735624
This clinical trial is testing a new treatment using two drugs, botensilimab and balstilimab, for patients with early-stage rectal cancer that is stable and does not require standard pre-surgery treatments. The study aims to see if this combination can help control the cancer before surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring a new treatment approach for patients with early-stage rectal cancer that is stable and does not require standard pre-surgery treatments. Participants will receive an initial dose of botensilimab followed by regular doses of balstilimab every two weeks for up to six months. The goal is to assess how well the cancer responds to this treatment before surgery and to determine if some patients can avoid surgery altogether if the cancer is significantly reduced.
Description
This clinical trial involves treating patients with early-stage rectal cancer using a combination of two drugs, botensilimab and balstilimab. The study will include 16 participants who will receive a single dose of botensilimab on the first day, followed by balstilimab every two weeks for up to six months. The aim is to see how the cancer responds to this treatment. If the cancer shrinks significantly, some patients may not need surgery and can be monitored instead. Those whose cancer does not respond well will receive standard care. The study includes regular check-ups and follow-ups to monitor safety and effectiveness.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with early-stage rectal cancer that is stable and does not require standard pre-surgery treatments.
- Cancer must be confirmed as stable by specific tests.
- Tumor must be visible through endoscopy.
- Must agree to participate and sign a consent form.
- Must be 18 years or older.
- Tumor must be measurable by MRI.
- Must be in good overall health with a performance status of 0 or 1.
- Must have adequate organ function based on specific blood tests.
- Must be evaluated by a team of specialists to discuss treatment options.
- Must agree to use effective birth control during and after the study if of childbearing potential.
Exclusion Criteria
- Tumor is not stable or has specific genetic markers that require different treatments.
- Have had previous treatments with similar drugs.
- Have had recent bowel obstruction or symptoms of it.
- Have uncontrolled bowel disorders or chronic diarrhea.
- Cancer has spread beyond the rectum.
- Have severe liver problems or heart disease.
- Have another active cancer or have had one in the last two years.
- Have had recent treatments with certain drugs or therapies.
- Have a history of lung disease or organ transplant.
- Have mental health or substance abuse issues that affect participation.
- Require certain medications that affect the immune system.
- Have active autoimmune diseases or infections.
- Have untreated or active infections like HIV, hepatitis, or tuberculosis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center (BIDMC) | 02215 | Boston | Massachusetts |
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