Study on Losartan and Nivolumab Combined with FOLFIRINOX and Radiation for Localized Pancreatic Cancer
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT03563248
This clinical trial is exploring a new treatment approach for pancreatic cancer using a combination of chemotherapy, blood pressure medication, immunotherapy, and radiation therapy before surgery.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is testing a combination of treatments to see if they can effectively treat pancreatic cancer. The treatments include a chemotherapy mix called FOLFIRINOX, the blood pressure medication Losartan, the immunotherapy drug Nivolumab, and radiation therapy. The goal is to find out if these treatments can shrink the tumor before surgery.
Description
This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment approach. The treatment involves a combination of drugs and therapies that are being studied to see if they can help treat pancreatic cancer. FOLFIRINOX is a chemotherapy mix that is already approved for treating pancreatic cancer. Losartan is a medication used to lower blood pressure, and Nivolumab is an immunotherapy drug that may help the immune system attack cancer cells. Radiation therapy is used to increase the effectiveness of immunotherapy. The study aims to see if this combination can shrink tumors before surgery.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with localized pancreatic cancer that is either borderline resectable or locally advanced.
- No spread of cancer outside the pancreas.
- Tumors that can be surgically removed or are locally advanced but not spread to distant organs.
- Age 18 or older.
- Good overall health with an ECOG performance status of 0 or 1.
- Blood pressure and organ function within specified limits.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
- Men must use contraception if sexually active with women of childbearing potential.
- Ability to understand and sign a consent form.
- Stable on a low dose of dexamethasone if applicable.
Exclusion Criteria
- Currently on ACE or ARB therapy for high blood pressure or kidney protection.
- Serious health conditions like heart or lung disease, recent heart attack, or ongoing infection.
- Pregnant or breastfeeding women.
- Previous treatment for pancreatic cancer.
- Other invasive cancers treated within the last five years.
- Digestive tract issues or malabsorption syndrome.
- Blood clotting disorders.
- Previous severe reaction to similar treatments.
- Participation in another drug study within the last four weeks.
- Uncontrolled seizures or psychiatric conditions.
- Recent major surgery without full recovery.
- Use of cimetidine, which affects 5-FU clearance.
- Allergies to study drugs.
- Active autoimmune diseases requiring treatment.
- Active tuberculosis or hepatitis infections.
- HIV or AIDS.
- Uncontrolled illnesses or psychiatric disorders.
- Recent live vaccine.
- Severe allergy to monoclonal antibodies.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| Sibley Memorial Hospital | 20016 | Washington D.C. | District of Columbia |
| The Johns Hopkins Hospital | 21287 | Baltimore | Maryland |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Brigham and Women's Hospital | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Newton Wellesley Hospital | 02462 | Newton | Massachusetts |
| New York University Langone Medical Center | 10016 | New York | New York |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.