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

Study Name
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 (if applicable)
NCT05849480
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Immunotherapy
Study Center
Institution Name
National Cancer Institute
City
Bethesda
State
Maryland
Zip Code
20892
Country
United States
Website
https://ccr.cancer.gov
Study Contacts
Principal Investigator
Cecilia Monge
P.I. Phone
(240) 858-3603
P.I. Email
cecilia.mongebonilla@nih.gov
List additional Principal Investigators (include phone number and email)
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
OVERVIEW – in layman’s terms (150 words max)
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
26
Study Start Date
03/27/2024
Estimated Completion Date
03/31/2025
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • test new immunotherapy for safety and efficacy
Inclusion Criteria – Patients Must:
  • BTC
Exclusion Criteria – Patients Must NOT:
  • autoimmune disease
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • none
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • typical side effects of chemotherapy
  • typical side effects of immunotherapy / rash /fever
Financial Assistance is available to participants for travel, lodging, etc.
  • Yes