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Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

ConditionsMetastatic Colon CancerStage III Colon Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon. Any T [Tx, T1, T2, T3, or T4-], N1-2M0.

Participants must have completely resected disease. In patients with tumor adherent to adjacent structures, en block RO resection must be documented.

Entire tumor must be in the colon (rectal involvement is excluded).

Participants must have completed standard adjuvant chemotherapy per the discretion of the treating physician. Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constitutes appropriate standard therapy in the opinion of the treating physician.

Disqualifiers

Patients who are receiving additional investigational therapy or on another investigational protocol

Patients who have confirmed metastatic disease per CT.

Patients who are unable to get any standard adjuvant therapy

Patients who have received more than 6 months of standard adjuvant therapy at the time of study entry.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

400 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ctDNA-POSITIVE: FOLFIRI ProtocolExperimental treatment 1 intervention
Group B: ctDNA-POSITIVE: ACTIVE SURVEILLANCEActive comparator 1 intervention
Group C: ctDNA-NEGATIVE: ACTIVE SURVEILLANCEActive comparator 1 intervention
Group D: ctDNA-POSITIVE MSI-H: NIVOLUMABExperimental treatment 1 intervention
Group E: ctDNA-POSITIVE BRAF Mutant: ENCORAFENIB/BINIMETINIB/CETUXIMABExperimental treatment 1 intervention
Group F: 6 Months Additional Trastuzumab and PertuzumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free survival (DFS)

Disease-free survival (DFS) between ctDNA-positive patients treated with additional treatment of FOLFIRI and ctDNA-positive patients who are untreated

Time frame
5 years
2

Clearance rate of ctDNA

Compare the clearance rate of ctDNA in ctDNA-positive patients between patients treated with additional treatment of FOLFIRI and those who are untreated

Time frame
7 Months

Secondary outcomes

1

Overall Survival (OS) Rate

Overall survival (OS) between ctDNA-positive patients treated with additional adjuvant therapy (Arm 1) and ctDNA-positive patients who are untreated (Arm 2)

Time frame
5 years
2

Clearance rate of ctDNA of Arm 4: Nivolumab Treatment

Determine clearance rate of ctDNA-positive patients treated with nivolumab in an exploratory MSI/mismatch repair deficient cohort

Time frame
13 months
3

Disease-free survival (DFS) of Arm 4: Nivolumab Treatment

Determine the disease-free survival (DFS) of ctDNA-positive patients treated with nivolumab in an exploratory MSI/mismatch repair deficient cohort

Time frame
5 years
4

Clearance rate of ctDNA of Arm 5: Encorafenib/Binimetinib/Cetuximab Treatment

Determine the clearance rate of ctDNA-positive patients treated with encorafenib, binimetinib, and cetuximab in an exploratory BRAF V600E cohort.

Time frame
7 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Stand Up To Cancer

Collaborator

Source ClinicalTrials.gov
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