Combination Immunotherapy for Treating Metastatic Colorectal Cancer Resistant to Chemotherapy
Sponsor: Dan Feng
ClinicalTrials ID:NCT07281716
This clinical trial is testing a new combination of immunotherapy drugs, nadunolimab and toripalimab, to see if they are safe and effective for patients with metastatic colorectal cancer that hasn't responded to chemotherapy.
Patient Parameters
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Program Overview
The study aims to find out if a combination of two immunotherapy drugs, nadunolimab and toripalimab, can help treat metastatic colorectal cancer that is resistant to chemotherapy. The trial will first test the safety of the treatment and then evaluate how well it works in shrinking tumors and controlling the disease. Participants will receive the treatment every three weeks for up to a year or until their cancer progresses. Researchers will also study how the treatment affects the immune system by analyzing tumor and blood samples.
Description
This study is divided into two phases. In Phase 1b, the focus is on ensuring the safety of the combination treatment with nadunolimab and toripalimab in a small group of patients. In Phase 2, the study will expand to include more patients to see how effective the treatment is in controlling cancer. Participants must have colorectal cancer that has not responded to standard chemotherapy treatments. They will receive the immunotherapy drugs through an IV every three weeks. The study will involve regular blood tests, imaging scans, and biopsies to monitor the treatment's effects. The trial is conducted at Mount Sinai Hospital and aims to provide new treatment options for patients with limited choices.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of colorectal cancer that is not responsive to standard chemotherapy.
- Cancer must have progressed after treatments like 5-FU, oxaliplatin, and irinotecan, with or without other drugs.
- Must have at least one tumor that can be measured and is suitable for biopsy.
- Must be willing to provide blood samples and undergo biopsies.
- Must be 18 years or older.
- Must be in good general health with a performance status score of 0 or 1.
- Women and men must agree to use effective birth control during the study and for four months after.
- Must be able to understand and sign a consent form.
- Must have adequate organ and bone marrow function.
Exclusion Criteria
- Recent chemotherapy within 14 days before starting the study.
- Receiving other experimental treatments.
- Uncontrolled illnesses or infections.
- Recent major surgery within four weeks before starting the study.
- Pregnant or nursing women.
- History of severe reactions to previous immunotherapy.
- Active autoimmune diseases requiring treatment in the past year.
- HIV positive with detectable viral load or not on stable treatment.
- Active hepatitis B or C infections.
- History of organ transplants.
- Recent live vaccines or certain medications.
- Allergies to protein-based treatments.
- Conditions that might interfere with the study or are not in the patient's best interest.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
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