| ClinicalTrials.gov Identifier |
| NCT06439485 |
| Institution Name |
| University of Texas MD Anderson Cancer Center |
| Institution Address (Street) |
| 1515 Holcombe Blvd |
| Institution Address (Line 2) |
| 1515 Holcombe Blvd |
| Institution State |
| Texas |
| Institution ZIP Code |
| 77030 |
| Institution Country |
| United States |
| Institution Phone |
| https://www.mdanderson.org/ |
| Institution Website |
| https://www.mdanderson.org/ |
| Additional Institutions |
| MD Anderson Single Center trial |
| Principal Investigator |
| Sunyoung S Lee, MD, PhD |
| Principal Investigator Phone |
| https://www.mdanderson.org/ |
| Principal Investigator Email |
| sslee1@mdanderson.org |
| Additional Principal Investigators |
| Milind Javle, MD, mjavle@mdanderson.org |
| Study Coordinator |
| Christine Fark |
| Study Coordinator Phone |
| 713-834-6614 |
| Study Coordinator Email |
| cfark@mdanderson.org |
| Study Overview |
| This study is focused on treating patients with advanced cholangiocarcinoma, a type of bile duct cancer, that have a genetic change called FGFR2 fusion. The trial combines three medications: pemigatinib, which targets the FGFR2 fusion, bevacizumab, which targets blood vessel growth in tumors, and atezolizumab, an immunotherapy drug that helps the immune system fight cancer. While FGFR inhibitors like pemigatinib have shown some effectiveness, their results often don’t last long, and some patients don’t respond to them. This trial is designed to test whether combining these drugs can provide better, longer-lasting outcomes for patients. |
| Enrollment Information |
| 25 |
| Study Start Date |
| 2024-10-15 |
| Study End Date |
| 2026-09-01 |
| Study Purpose |
| This study is aimed at treating patients with a specific type of bile duct cancer (cholangiocarcinoma) that has a genetic alteration called FGFR2 fusion. The treatment combines three medications: pemigatinib, which targets the FGFR2 fusion, atezolizumab, which is an immunotherapy drug, and bevacizumab, which targets blood vessel growth in tumors. Pemigatinib or futibatinib, both FGFR inhibitors, do not maintain efficacy for long periods, and there is a population of patients who do not respond to FGFR inhibitors alone. We developed this trial to overcome these limitations by combining therapies to see if this combination can slow or stop cancer growth more effectively, especially after patients have already tried other chemotherapy treatments. |
| Inclusion Criteria |
| • Has histologically confirmed metastatic or advanced unresectable cholangiocarcinoma.
• Has disease that is measurable per the RECIST v1.1.
• Has at least one measurable target lesion.
• Has FGFR2 fusion or rearrangement in tumor tissue. Presence of the FGFR2 fusion and rearrangement should be determined by CLIA-validated genomic testing of a tumor tissue specimen (DNA-based or RNA-based).
• Is refractory to, has demonstrated intolerance to, had received, or has refused access to, the 1st line systemic therapy including gemcitabine-based therapy with or without immunotherapy including durvalumab or pembrolizumab. Patients who discontinued available standard therapy due to toxicity must have continued evidence of measurable disease. |
| Exclusion Criteria |
| • Received prior chemotherapy, biologic therapy, immunotherapy, or investigational agent within 3 weeks prior to enrollment.
• Had previous treatment with selective FGFR inhibitors including erdafitinib, infigratinib, or futibatinib.
• Had prior therapy with any VEGFR-targeting agent targeting including bevacizumab, ramucirumab, pazopanib, lenvatinib, and other anti-angiogenesis inhibitors.
• Has a history and/or has current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system, and lung. Exceptions include calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcifications—these are allowed.
• Has corneal or retinal disorder/keratopathy with current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, inflammation or ulceration, keratoconjunctivitis, or diabetic retinopathy, confirmed by ophthalmic physician. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study. |
| Required Tests Prior to Study |
| We want to make sure that your bile duct cancer has a specific genetic change called an FGFR2 fusion or rearrangement before starting the treatment. This genetic change helps us know if this treatment is right for you. |
| Potential Side Effects |
| Pemigatinib can raise phosphorus levels in your body, so we will monitor that closely. It, like other FGFR inhibitors, may also cause dryness in your hair, skin, and nails, and in rare cases, it can cause blurry vision. Bevacizumab, another part of your treatment, has rare side effects like increased blood pressure, a slight risk of bleeding or blood clots, and potential kidney injury. Atezolizumab, an immunotherapy drug, works by boosting your immune system, but sometimes your immune cells might mistakenly attack healthy organs. Common side effects include thyroid issues (7-10% of patients), diarrhea from colon inflammation, liver inflammation (2-4%), or inflammation in other organs. Overall, 20-30% of patients experience side effects from immunotherapy, but they are usually manageable, and we carefully monitor and treat every patient receiving this type of treatment for bile duct cancer. |
| Financial Assistance Available |
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