A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)

ClinicalTrials.gov Identifier
NCT05849480
Institution Name
National Cancer Institute
Institution City
Bethesda
Institution State
Maryland
Institution ZIP Code
20892
Institution Country
United States
Institution Website
https://ccr.cancer.gov
Principal Investigator
Cecilia Monge
Principal Investigator Phone
(240) 858-3603
Principal Investigator Email
cecilia.mongebonilla@nih.gov
Additional Principal Investigators
Tim Greten (240) 760 6114 tim.greten@nih.gov
Study Coordinator
Donna Mabry Hrones
Study Coordinator Phone
(240) 858-3155
Study Coordinator Email
donna.mabry@nih.gov
Study Overview
In this study we test the combination of two different immunotherapy drugs (anti-CD40 and anti-PD1) in combination with chemotherapy (capecitabine and oxaliplatin (CAPOX). This study is being offered to all patients who failed first-line treatment or refused first-line therapy. The study concept and preclinical data has been supported by the CCF.
Enrollment Information
26
Study Start Date
20240327
Study End Date
20250331
Study Purpose
  • test new immunotherapy for safety and efficacy
Inclusion Criteria
  • BTC
Exclusion Criteria
  • autoimmune disease
Required Tests Prior to Study
  • none
Potential Side Effects
  • typical side effects of chemotherapy
  • typical side effects of immunotherapy / rash /fever
Financial Assistance Available
Yes