Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

April 16, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Metastatic Colon CancerStage III Colon Cancer
Interventions
DRUG

FOLFIRI Protocol

FOLFIRI cycle will be two weeks (14 days) long, with FOLFIRI administered on Days 1-3. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of FOLFIRI chemotherapy.

OTHER

ACTIVE SURVEILLANCE

Will be followed with observation and monitoring with imaging, tumor markers, and ctDNA collections

DRUG

Nivolumab Protocol

Nivolumab cycle will be four weeks (28 days) long, with Nivolumab administered on day 1. Participants will receive up to 12 four-week cycles (for a total of 48 weeks) of Nivolumab treatment.

DRUG

Encorafenib/Binimetinib/Cetuximab Protocol

Encorafenib/Binimetinib will be taken orally every day and Cetuximab will be administered intravenously on day 1 of each cycle. Cycles are 14 days long. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of Encorafenib/Binimetinib/Cetuximab.

DRUG

Trastuzumab + Pertuzumab

Trastuzumab (Herceptin) is received by intravenous administration and Pertuzumab is received intravenously by infusion on Day 1 of each cycle. Cycles are 21 days long. Participants will receive up to 8 cycles of Trastuzumab and Pertuzumab.

Trial Locations (3)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

RECRUITING

Weill Cornell Medical College, New York

02115

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Stand Up To Cancer

OTHER

lead

Massachusetts General Hospital

OTHER