Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03803553
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metastatic Colon Cancer
  • Stage III Colon Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFIRI Protocol — DRUG
    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.
  • ACTIVE SURVEILLANCE — OTHER
    Will be followed with observation and monitoring with imaging, tumor markers, and ctDNA collections
  • Nivolumab Protocol — DRUG
    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.
  • Encorafenib/Binimetinib/Cetuximab Protocol — DRUG
    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.
  • Trastuzumab + Pertuzumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Apr 16, 2020
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ctDNA-POSITIVE: FOLFIRI Protocol
    Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study . The participant will be randomized into 1 of 3 groups : ctDNA-Positive: Folfiri or ctDNA-Positive: Active Surveillance or ctDNA Negative: Active Surveillance \- ctDNA-POSITIVE: FOLFIRI Protocol * FOLFIRI chemotherapy via intravenous infusion on days 1-3 of each cycle. Cycle is 14 days long. This will occur for up to 12 cycles (24 weeks). * infusions will consist of the drugs * 5-Fluorouracil * Irinotecan * Leucovorin
  • Active Comparator: ctDNA-POSITIVE: ACTIVE SURVEILLANCE
    Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study . The participant will be randomized into 1 of 3 groups : ctDNA-Positive: Folfiri or ctDNA-Positive: Active Surveillance or ctDNA Negative: Active Surveillance \-- Active surveillance. * Observation and monitoring with imaging (every 3 months), tumor markers, and ctDNA draws every 1 month for the initial 6 months. * After 6 months, followed with ctDNA, tumor markers, and scans every 3 months for the first 3 years and every 6 months thereafter. Additional scans and tumor markers will be at the discretion of the clinician. .
  • Active Comparator: ctDNA-NEGATIVE: ACTIVE SURVEILLANCE
    Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study . The participant will be randomized into 1 of 3 groups : ctDNA-Positive: Folfiri or ctDNA-Positive: Active Surveillance or ctDNA Negative: Active Surveillance \- Observation and monitoring with imaging, tumor markers, and ctDNA collections every 3 months for the first 3 years and every 6 months thereafter. Additional scans and tumor markers will be at the discretion of the clinician
  • Experimental: ctDNA-POSITIVE MSI-H: NIVOLUMAB
    Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study and is ctDNA positive and MSI-H, the participant will not be randomized and will be placed into the group: ctDNA positive, MSI-H: Nivolumab -ctDNA-Positive, MSI-H: Nivolumab Protocol * Nivolumab treatment via intravenous infusion on day 1 of each cycle. Cycle is 28 days long. This will occur for up to 12 cycles (48 weeks). * infusions will consist of the drug Nivolumab
  • Experimental: ctDNA-POSITIVE BRAF Mutant: ENCORAFENIB/BINIMETINIB/CETUXIMAB
    Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. If these tests show that the participant is eligible to participate in the research study and is ctDNA positive and has a BRAF mutation, the participant will not be randomized and will be placed into the group: ctDNA positive, BRAF mutant: Encorafenib/Binimetinib/Cetuximab -ctDNA-Positive, MSI-H: Encorafenib/Binimetinib/Cetuximab Protocol * Encorafenib/Binimetinib treatment is received orally every day and Cetuximab via intravenous infusion on day 1 of each cycle. Cycle is 14 days long. This will occur for up to 12 cycles (24 weeks). * infusions will consist of the drug Cetuximab
  • Experimental: 6 Months Additional Trastuzumab and Pertuzumab
    Pre-screening evaluation, including tumor assessment, tumor sequencing and blood tests. Participants that are eligible to receive Trastuzumab and Pertuzumab will be placed in this HER2 cohort: ctDNA-positive \& HER2 amplification and MSS Trastuzumab and Pertuzumab. Trastuzumab is received via intravenous administration, and Pertuzumab treatment is received intravenously by infusion. Cycle is 21 days. This will occur for up to 8 cycles.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115
Aparna Parikh, MD
[email protected]
Aparna Parikh, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Rona Yaeger, MD
[email protected]
Rona Yaeger, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10065
Manish Shah, MD
[email protected]
Manish Shah, MD (PRINCIPAL_INVESTIGATOR)

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Massachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYWeill Cornell Medical College· New York, NY

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