Publications by authors named "M M Javle"
Safety and Efficacy of Toripalimab in Patients with Cholangiocarcinoma: An Open-Label, Phase 1 Study.
J Immunother Precis Oncol
February 2025
Introduction: This was the first phase 1 study conducted in the United States. It consisted of dose-escalation (part A) and multiple indication-specific cohort expansion (part B), investigating the safety and preliminary efficacy of toripalimab (anti-programmed cell death-1 inhibitor) in patients with advanced malignancies.
Methods: Patients with advanced malignancies that progressed after treatment with at least one prior line of standard systemic therapy, including the patients with advanced/recurrent cholangiocarcinoma (CCA), received toripalimab 240 mg every 3 weeks in part B.
Background: Following tumor resection, imaging recommendation for the follow-up of patients with intrahepatic cholangiocarcinoma (IHCCA) include frequent chest, abdomen and pelvis computed tomography (CT) imaging. The appropriateness of additional imaging studies is usually derived from their clinical utility. The purpose of this work is to determine the value of chest CT imaging in the follow-up of patients with IHCCA.
View Article and Find Full Text PDFPurpose: Biliary tract cancers (BTCs) include intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancers. BTCs have a number of genomic alterations, including isocitrate dehydrogenase 1 () mutations, fibroblast growth factor receptor 2 () rearrangements, and amplifications. Therapies targeting these alterations have shown clinical benefit in patients with BTCs in the United States.
View Article and Find Full Text PDFArticle Synopsis
- FGFR inhibitors have shown promise in treating FGFR-altered cholangiocarcinoma, but acquired resistance poses a challenge to their effectiveness.
- The study utilized diverse investigative methods, including DNA analysis and tissue biopsies, to explore resistance mechanisms in a cohort of patients.
- Results indicated that a significant number of patients with clinical benefits had specific FGFR2 mutations, but polyclonal resistance was influenced by low drug concentrations and specific mutation types affecting drug efficacy.
Purpose: SWOG S1815 was a randomized, open label phase III trial, evaluating gemcitabine, nab-paclitaxel, and cisplatin (GAP) versus gemcitabine and cisplatin (GC) in patients with newly diagnosed advanced biliary tract cancers (BTCs).
Methods: Patients with newly diagnosed locally advanced unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (ICC) and extrahepatic cholangiocarcinoma (ECC) and gallbladder carcinoma (GBC), were randomly assigned 2:1 to either GAP (gemcitabine 800 mg/m, cisplatin 25 mg/m, and nab-paclitaxel 100 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle) or GC (gemcitabine 1,000 mg/m and cisplatin 25 mg/m intravenously once per day on days 1 and 8 of a 21-day cycle).
Results: Among 452 randomly assigned participants, 441 were eligible and analyzable, 67% with ICC, 16% with GBC, and 17% with ECC.