Encorafenib for Disease Progression

1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Disease Progression+20 More
Encorafenib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Disease Progression

Study Summary

This study is evaluating whether a combination of drugs may be more effective than a single drug in treating colorectal cancer.

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Eligible Conditions

  • Disease Progression
  • Colorectal Cancer
  • Adenocarcinoma
  • Cancer of Rectum
  • Carcinoma
  • Stage IV Colorectal Cancer AJCC v8
  • Colorectal Neoplasms
  • Recurrent Colorectal Carcinoma
  • Stage IIIB Colorectal Cancer AJCC v8
  • Progressive Disease
  • Stage IVC Colorectal Cancer AJCC v8
  • Rectal Neoplasms
  • Metastatic Rectal Adenocarcinoma
  • Metastatic Colon Adenocarcinoma
  • BRAF NP_004324.2:p.V600E
  • Stage IVA Colorectal Cancer AJCC v8
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Stage III Colorectal Cancer AJCC v8
  • Unresectable Colon Adenocarcinoma
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Unresectable Rectal Adenocarcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Encorafenib will improve 2 primary outcomes and 4 secondary outcomes in patients with Disease Progression. Measurement will happen over the course of Up to 28 days.

Up to 28 days
Incidence of treatment-related grade 3 adverse events
Up to 5 years
Duration of response
Overall survival
Progression-free survival
Time to response
Month 6
Best radiographic response

Trial Safety

Trial Design

2 Treatment Groups

Control
Treatment (encorafenib, cetuximab, nivolumab)

This trial requires 38 total participants across 2 different treatment groups

This trial involves 2 different treatments. Encorafenib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (encorafenib, cetuximab, nivolumab)Patients receive encorafenib PO QD on days 1-28, cetuximab IV over 1 hour on days 1 and 15, and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
FDA approved
Encorafenib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has been diagnosed with Colon Adenocarcinoma, which is an unresectable and/or metastatic cancer that can be measured using RECIST 1.1 criteria. show original
People with metastatic colorectal cancer who have been treated with at least one, but no more than two, systemic chemotherapy regimens are may be eligible for this study show original
The person has a very good performance status, with only minor limitations in their activities. show original
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) are usually less than 2.5 times the upper limit of normal. show original
is required for all patients initiating targeted therapy with trametinib BRAFV600E tumor must be confirmed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory in order to start treatment with trametinib. show original
A person has hemoglobin levels of at least 9 grams per deciliter of blood with or without transfusions. show original
for 3 days or more A person has platelets (PLT) >= 100 x 10^9/L without transfusions for 3 days or more if they have at least 100,000,000 platelets and they have not received a transfusion in the last 3 days. show original
Provision of signed informed consent prior to any screening procedures being performed
Confirmation of microsatellite stable (MSS) status in a CLIA-certified laboratory
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How quickly does disease progression spread?

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There is minimal heterogeneity in time to [disease progression|death] among patients with ILDs. The rapid progression of ILD is similar to other inflammatory and nonspecific inflammatory diseases.

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What is disease progression?

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It is an extremely difficult proposition to define the progression of a disease and what components should comprise that definition. This is the first work to define progression of an immunological disorder using the criteria that our data suggest are most relevant. We propose a simple definition of what would be progression in this disorder based on a series of biomarkers that provide a snapshot of different aspects of disease activity as described by patient reports, clinical laboratory results, and imaging, at different time points.

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What causes disease progression?

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Although there are many known factors influencing cancer disease progression, there is also an influence involving the immune and nervous systems, with their immunomodulation affecting progression of cancer and inflammatory conditions. Progression of cancer may also be affected by the type of cancer, and the immune response to the presence of a malignancy.

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How many people get disease progression a year in the United States?

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Findings from a recent study show that about three out of ten will experience disease progression annually depending on when they start treatment and depending on racial and ethnic group. This is a major finding and requires further discussion among clinicians, patient groups, and health care policy makers.

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What are common treatments for disease progression?

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Overall, this pilot study found that common treatment for disease progression in the community setting includes medications (especially antihypertensive medications), physical therapy, osteopathy, and chiropractic.

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Can disease progression be cured?

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Though no single disease manifestation or progression is curable, a combination of the features of these manifestations might make the disease progression less predictable than once thought.

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What are the signs of disease progression?

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These are symptoms of progression of the disease such as cognitive impairment, psychiatric symptoms, decreased life function and decreased quality of life. This list may be helpful to understand the disease progression of the disease.

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Does disease progression run in families?

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The disease progression between siblings was not significantly different than that between non-siblings, but the disease progressions between members of the same family tended to be more similar than those between members of different families. Results from a recent clinical trial do not support the existence of a heritable component in familial Alzheimer disease.

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Does encorafenib improve quality of life for those with disease progression?

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Encorafenib improved quality of life for patients with metastatic colorectal cancer. Patients who had a complete response to treatment had a significant improvement in quality of life.

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Is encorafenib safe for people?

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In contrast to the previous experiences with sorafenib, encorafenib has no effect on liver function in patients with metastatic HCC who receive it as part of maintenance therapy.

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What does encorafenib usually treat?

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Sorafenib is active in an advanced phase III trial in patients with advanced HCC; however, this drug may also be effective in a subset of patients with advanced RCC.

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What are the chances of developing disease progression?

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Patients with primary sclerosing cholangitis will develop renal disease, and if renal function is reduced to a stage necessitating haemodialysis, more than half the patients eventually will develop renal failure requiring a renal transplantation. Diabetes does not seem to have a significant impact on outcome.

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