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Targeted Therapy for Colorectal Cancer

Phase 3

Recruiting

Led By Aparna Parikh, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Patient must have completed resected disease

Must not have

Patient who have received more than 3-6 months of standard adjuvant therapy at the time of study entry

Has a known additional malignancy that is progressing or requires active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing which of these treatments is better based on blood test results.

Who is the study for?

This trial is for adults over 18 with Stage III colon cancer that's been surgically removed. They must have finished standard chemo, not received neoadjuvant chemo, and be in good health with a life expectancy over 3 months. Women should test negative for pregnancy and all participants must agree to use contraception.

What is being tested?

The study compares two standard treatments based on blood tests for metastatic colorectal cancer: active surveillance or one of the FOLFIRI, Nivolumab, or Encorafenib/Binimetinib/Cetuximab protocols. The choice depends on specific genetic markers in the tumor DNA.

What are the potential side effects?

Potential side effects include fatigue, nausea from chemotherapy (FOLFIRI), skin reactions from targeted therapy (Encorafenib/Binimetinib/Cetuximab), and immune-related issues like inflammation from immunotherapy (Nivolumab). Each treatment has its unique set of possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer has been surgically removed.

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My cancer has a known mismatch repair deficiency.

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I have finished the standard additional cancer treatment.

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My colorectal cancer is Stage III and was confirmed through a biopsy.

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My organs and bone marrow are functioning normally.

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I have not had chemotherapy before surgery.

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I am willing to use two forms of birth control or abstain from sex.

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My cancer is located only in the colon, not the rectum.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had more than 3-6 months of standard follow-up cancer treatment.

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I have another cancer that is getting worse or needs treatment.

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I cannot receive standard follow-up cancer treatment.

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I have a serious illness that is not under control.

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I am currently being treated for an infection.

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I do not have a BRAFV600E mutation and am not MSI-high.

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My cancer has spread to other parts of my body, confirmed by a CT scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clearance rate of ctDNA

Disease-free survival (DFS)

Secondary study objectives

Clearance rate of Arm 6: Herceptin/Perjeta

Clearance rate of ctDNA of Arm 4: Nivolumab Treatment

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

+6 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: ctDNA-POSITIVE: FOLFIRI ProtocolExperimental Treatment1 Intervention

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

Group II: ctDNA-POSITIVE MSI-H: NIVOLUMABExperimental Treatment1 Intervention

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

Group III: ctDNA-POSITIVE BRAF Mutant: ENCORAFENIB/BINIMETINIB/CETUXIMABExperimental Treatment1 Intervention

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

Group IV: 6 Months Additional Trastuzumab and PertuzumabExperimental Treatment1 Intervention

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.

Group V: ctDNA-POSITIVE: ACTIVE SURVEILLANCEActive Control1 Intervention

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. .

Group VI: ctDNA-NEGATIVE: ACTIVE SURVEILLANCEActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

FDA approved

0 / 17Eligibility criteria met