Encorafenib Pill for Melanoma

Moffitt Cancer Center, Tampa, FL
Melanoma+2 More ConditionsEncorafenib Pill - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial looks at how effective neoadjuvant therapy is in treating cancer, and whether adjuvant therapy after surgery can help prevent disease relapse.

Eligible Conditions
  • Metastatic Melanoma
  • Melanoma Stage III
  • BRAF V600E Mutation

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: After surgery, up to 5 years

Week 24
Rate of Disease Relapse
Relapse Free Survival
Year 5
Overall Survival
At 26 weeks
Rate of Non-Pathologic Complete Response
Rate of Pathologic Complete Response
Up to 26 weeks
Overall Response Rate

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

4 Treatment Groups

Surveillance
1 of 4
Encorafenib and Binimetinib after Pathologic Complete Response
1 of 4
Nivolumab after Non-Pathologic Complete Response
1 of 4
Encorafenib and Binimetinib after Non-Pathologic Complete Response
1 of 4

Active Control

Experimental Treatment

50 Total Participants · 4 Treatment Groups

Primary Treatment: Encorafenib Pill · No Placebo Group · Phase < 1

Encorafenib and Binimetinib after Pathologic Complete ResponseExperimental Group · 2 Interventions: Encorafenib Pill, Binimetinib Pill · Intervention Types: Drug, Drug
Nivolumab after Non-Pathologic Complete ResponseExperimental Group · 3 Interventions: Encorafenib Pill, Binimetinib Pill, Nivolumab · Intervention Types: Drug, Drug, Drug
Encorafenib and Binimetinib after Non-Pathologic Complete ResponseExperimental Group · 2 Interventions: Encorafenib Pill, Binimetinib Pill · Intervention Types: Drug, Drug
SurveillanceActiveComparator Group · 2 Interventions: Encorafenib Pill, Binimetinib Pill · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after surgery, up to 5 years

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
514 Previous Clinical Trials
128,226 Total Patients Enrolled
41 Trials studying Melanoma
3,341 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,403 Previous Clinical Trials
25,776,420 Total Patients Enrolled
48 Trials studying Melanoma
49,516 Patients Enrolled for Melanoma
Zeynep Eroglu, MDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Melanoma
25 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Has research been conducted beyond the scope of Encorafenib Pill?

"Currently, 767 trials are researching the efficacy of Encorafenib Pill. Of these examinations, 86 have progressed to Phase 3. The majority of studies for this medication take place in Cambridge, England; however, there are over 42 thousand locations running clinical tests on this pharmaceutical treatment." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor in need of more participants?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was initially posted on May 24th 2021, is presently recruiting for 50 participants at one location. It has also been updated most recently on November 2nd 2022." - Anonymous Online Contributor

Unverified Answer

How does this research compare to other similar initiatives?

"Since 2011, researchers have been exploring the potential of Encorafenib Pill. Pfizer was responsible for leading the initial trial in 2011 with 183 participants; this led to a Phase 2 drug approval. Currently there are 767 studies active across 2574 cities and 51 countries investigating its effects." - Anonymous Online Contributor

Unverified Answer

To what extent is the current clinical trial being populated by participants?

"Affirmative. Per the clinicaltrials.gov website, recruitment for this trial is in progress. The study was published on May 24th 2021 and last modified on November 2nd 2022; 50 participants must be sourced from a single medical site." - Anonymous Online Contributor

Unverified Answer

To what ailments can Encorafenib Pill be administered to provide relief?

"Encorafenib Pill has been proven to be an effective management strategy for malignant neoplasms, unresectable melanoma and squamous cell carcinoma." - 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.