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Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

NCT03803553 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-01

No results posted yet for this study

Summary

This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer.

The names of the potential treatments involved in this study are:

* Active surveillance
* FOLFIRI treatment
* Nivolumab treatment
* Encorafenib/Binimetinib/Cetuximab treatment
* Trastuzumab + Pertuzumab

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Aparna Parikh, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03803553 on ClinicalTrials.gov