Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
M.D. Anderson Cancer Center
Summary
To learn if pemigatinib in combination with atezolizumab and bevacizumab can help to control cholangiocarcinoma.
Description
Primary Objectives: • To assess the antitumor activity of the treatment combinations based on objective response rate (ORR) Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. This assessment will be confirmed in the next scheduled scan. Secondary Objectives: 1. To determine the safety and recommended phase 2 dose (RP2D) of the triple combination of pemigatinib with bevacizumab and atezolizumab in participants with FGFR-altered metastatic CCA. 2. To evaluate the duration of response in participants with best overall response of complete response (CR) or partial response (PR). 3. To…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and willingness to sign informed consent. * Age ≥18 years. * 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, as 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 thera…
Interventions
- DrugPemigatinib
Given by PO
- DrugAtezolizumab
Given by PO and IV
- DrugBevacizumab
Given by PO and IV
Location
- MD Anderson Cancer CenterHouston, Texas