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Kinase Inhibitor

Dabrafenib for Cutaneous Melanoma

Phase 2

Waitlist Available

Led By Rodabe N Amaria

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying a combination of drugs as a possible treatment for melanoma that has spread to other parts of the body and does not respond to initial treatment.

Eligible Conditions

Cutaneous Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Relapse-free survival (RFS) rate

Secondary outcome measures

Distant metastasis-free survival

Incidence of adverse events

Overall survival

Other outcome measures

Association between circulating blood markers and treatment response and relapse

Immune and molecular features of response and resistance

Operative Surgical Procedures

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (dabrafenib, trametinib, surgery, spartalizumab)Experimental Treatment4 Interventions

NEOADJUVANT TREATMENT: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgical resection of melanoma. ADJUVANT TREATMENT OF pCR PATIENTS: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeats every 28 days for 44 weeks in the absence of disease progression or unacceptable toxicity. ADJUVANT TREATMENT OF NON pCR PATIENTS: Patients receive spartalizumab IV over 30 minutes on day 1, dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeats every 28 days for 44 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spartalizumab

Not yet FDA approved

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Dabrafenib

FDA approved

Trametinib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,313 Total Patients Enrolled

2 Trials studying Cutaneous Melanoma

5,053 Patients Enrolled for Cutaneous Melanoma

Rodabe N AmariaPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

154 Total Patients Enrolled

1 Trials studying Cutaneous Melanoma

53 Patients Enrolled for Cutaneous Melanoma

Media Library

Dabrafenib; Trametinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04310397 — Phase 2

Cutaneous Melanoma Research Study Groups: Treatment (dabrafenib, trametinib, surgery, spartalizumab)

Cutaneous Melanoma Clinical Trial 2023: Dabrafenib; Trametinib Highlights & Side Effects. Trial Name: NCT04310397 — Phase 2

Dabrafenib; Trametinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04310397 — Phase 2

Frequently Asked Questions

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

Is there still an opportunity for individuals to participate in this medical experiment?

"Unfortunately, this trial is not currently enrolling. It was first listed on January 29th 2020 and had its last update on August 9th 2022. If you are curious about other clinical trials related to melanoma, 816 studies are recruiting patients at present while 118 accept participants for Dabrafenib-related research."

Answered by AI

What earlier research initiatives have explored the potential of Dabrafenib?

"At the moment, 118 clinical trials are examining Dabrafenib's efficacy with 6 in Phase 3. The bulk of these studies are taking place in New york City, yet there is a substantial number of locations currently executing research for this drug (6111 to be exact)."

Answered by AI

What detrimental effects might Dabrafenib have on those who take it?

"Dabrafenib is currently being rated at a 2, as there exists some data corroborating its safety but none attesting to it's efficacy."

Answered by AI

Is this endeavor revolutionary in comparison to prior experiments?

"At present, there are 118 active trials for Dabrafenib in 1166 urban areas and 41 countries. This pharmacological treatment was first tested back in 2011 with funding from Novartis Pharmaceuticals and involved 185 human participants who went through the Phase 1 approval stage. Since then, 139 studies have been completed as of today."

Answered by AI

How many participants are being observed in this clinical experiment?

"At this time, no new patients are being accepted into the trial. The initiative was first posted on January 29th 2020 and had its last update on August 9th 2022. However, 816 clinical trials for melanoma and 118 studies testing Dabrafenib remain open to participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

2020. "Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04310397.