Encorafenib for Cancer of Skin

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Cancer of Skin+4 More
Encorafenib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called binimetinib and a drug called encorafenib can help control melanoma that has spread to the brain.

See full description

Eligible Conditions

  • Cancer of Skin
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer of Skin

Study Objectives

This trial is evaluating whether Encorafenib will improve 4 primary outcomes and 6 secondary outcomes in patients with Cancer of Skin. Measurement will happen over the course of Up to 28 days.

At 3 months
Progression free survival (PFS) (Cohort A)
Year 3
Duration of response (DOR)
Year 3
Overall survival (OS)
Year 3
Progression free survival
Up to 28 days
Incidence of dose-limiting toxicities (DLTs)
Up to 3 years
Disease control rate
Extracranial response rate
Incidence of dose interruptions, dose modifications and discontinuations due to AEs
Intracranial response rate
Day 30
Incidence of adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cancer of Skin

Trial Design

1 Treatment Group

Treatment (encorafenib, binimetinib)
1 of 1
Experimental Treatment

This trial requires 35 total participants across 1 different treatment group

This trial involves a single treatment. 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 2 and have already been tested with other people.

Treatment (encorafenib, binimetinib)Patients receive encorafenib PO QD and binimetinib PO BID on day 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
FDA approved
Encorafenib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 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. You must have received newly diagnosed for Cancer of Skin or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able to provide written informed consent. Adult patients under guardianship may participate if permitted by local regulations with the consent of their legally authorized guardian. All local regulations concerning patients under guardianship must be followed
Age >= 18 years at the time of informed consent
Histologically confirmed diagnosis of melanoma
Presence of BRAFV600 mutation in tumor tissue previously determined by a local assay (including immunohistochemistry [IHC]) at any time prior to Screening or during Screening
Cohort A: BRAF V600 mutant melanoma patients with progressive central nervous system (CNS) metastases. This includes patients with parenchymal brain metastases and/or LMD
Cohort A: Prior therapy with Food and Drug Administration (FDA)-approved BRAF inhibitors (+/- MEK inhibitors) is required
No washout period is required
Cohort B: BRAF V600 mutant melanoma patients who are treatment naive to BRAF/MEK inhibitors with CNS metastases, including LMD. Prior treatment with immunotherapy is permitted
For patients with parenchymal brain metastases (mets) without LMD
Metastatic disease to the brain with at least 1 progressing parenchymal brain lesion >= 0.5 cm and =< 3 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension

Patient Q&A Section

How quickly does melanoma spread?

"The rate of metastatic spread to regional lymph nodes in stage III melanomas is very low (3%). The presence of ulceration correlated significantly with lymph node metastasis. No statistically significant difference was found between the infiltration-based T staging system and the lymph node involvement status. Whether the removal of the primary tumor before sentinel lymph node biopsy should be considered remains to be determined." - Anonymous Online Contributor

Unverified Answer

How does encorafenib work?

"Encouraging results have been obtained from clinical trials investigating the effectiveness of encorafenib as a targeted therapy for advanced melanoma. These data support further investigation of encorafenib as a potentially effective therapy for patients with metastatic melanoma." - Anonymous Online Contributor

Unverified Answer

What are the signs of melanoma?

"The majority of patients had detectable melanomas at the time they were diagnosed; however, many also had silent or asymptomatic lesions at this time. Most patients were diagnosed by examination. None had routine skin examinations or a history of sun exposure prior to diagnosis. Many patients already had at least one previous dermatological visit, even before their diagnosis of melanoma. All patients should have a full dermatologic exam when first presenting with symptoms suggestive of melanoma." - Anonymous Online Contributor

Unverified Answer

What does encorafenib usually treat?

"Encouraging results have been obtained with intravenous administration of the MEK inhibitor, encorafenib. Recent findings should inspire further development of other MEK inhibitors as anti-cancer agents." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in encorafenib for therapeutic use?

"Encouraging results from phase II trials have been reported and show that the combination therapy of encorafenib plus chemotherapy prolongs progression free survival compared with chemotherapy alone. Further studies to assess its usefulness in selected patients with advanced disease are warranted." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"Melanoma is a deadly disease that can affect anyone of any age, sex or race. It may appear as any type of mole, which is a dark spot on the skin, but which can change over time, becoming larger or smaller, darker or lighter, or even itchiness. A small percentage of moles become cancerous.\nMelanoma is a form of skin cancer that begins when normal cells grow out of control. Most often, this happens because the body doesn't produce enough tumor suppressor protein p53. Other factors include ultraviolet light exposure, sunburn, clustering of moles, genetics, family history of melanoma, and skin color." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving encorafenib?

"Encorafenib has shown promising activity in patients with advanced melanomas. Findings from a recent study support further study of encorafenib in patients with advanced melanomas, as well as in earlier stages of disease. The lack of dose-limiting toxicities in our study suggests that encorafenib can be used safely at standard doses in patients with advanced melanomas." - Anonymous Online Contributor

Unverified Answer

Is encorafenib typically used in combination with any other treatments?

"The majority of patients who received encorafenib as monotherapy exhibited no improvement in disease progression-free survival or overall survival compared with those receiving placebo. Encorafenib was associated with increased rates of hepatotoxicity and pneumonitis." - Anonymous Online Contributor

Unverified Answer

What is encorafenib?

"Encouraging results have been observed from the REGN-EB3 Phase II trial comparing encorafenib with dacarbazine plus temozolomide. Recent findings examined patients with advanced melanoma. Patients were randomized (1:1) to receive standard chemotherapy or encorafenib plus the same chemotherapy. Encorafenib was well tolerated, although it increased overall mortality and progression-free survival compared with standard chemotherapy. In particular, treatment with encorafenib resulted in increased rates of grade 3 or 4 adverse events and decreased rates of grade 3 or 4 responses." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing melanoma?

"We can't predict whether someone will develop any type of cancer, including melanoma. However, there are certain factors that may help to determine how likely someone is to get melanoma. These include having a family member who had some type of cancer (e.g., melanoma) or having a history of skin cancer. Studying your family history for melanoma or similar illnesses can help to identify your risk for developing the disease." - Anonymous Online Contributor

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