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