Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

May 8, 2023

Primary Completion Date

July 1, 2027

Study Completion Date

January 1, 2028

Conditions
Colorectal CarcinomaColorectal NeoplasmLynch Syndrome
Interventions
BIOLOGICAL

Adenovirus 5 CEA/MUC1/Brachyury Vaccine Tri-Ad5

Given SC

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Colonoscopy

Undergo SOC colonoscopy

DRUG

Nogapendekin Alfa

Given nogapendekin alfa inbakicept (N-803) SC

DRUG

Placebo Administration

Given SC

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (14)

19111

Fox Chase Cancer Center, Philadelphia

43210

Ohio State University Comprehensive Cancer Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

55905

Mayo Clinic in Rochester, Rochester

60611

Northwestern University, Chicago

66160

University of Kansas Cancer Center, Kansas City

77030

M D Anderson Cancer Center, Houston

85054

Mayo Clinic Hospital in Arizona, Phoenix

85719

University of Arizona Cancer Center - Prevention Research Clinic, Tucson

94143

UCSF Medical Center-Parnassus, San Francisco

80217-3364

University of Colorado, Denver

02215

Dana-Farber Cancer Institute, Boston

00936

University of Puerto Rico, San Juan

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH