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A Phase 2 Trial of Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase 2 Trial of Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation

Inclusion Criteria:

- AJCC (2009) stage IIIC cutaneous melanoma rendered free of disease by surgical
resection no greater than 6 week prior study enrollment. Patients with unknown
primaries will be eligible for this trial. Patients with a history of resected stage
I or II cutaneous melanoma who subsequently have their first disease recurrence
meeting the criteria for stage IIIC disease will also be eligible for this trial.

- Patients must have clear margins after wide local excision. Patients must have an
adequate completion lymph node dissection defined by the number of lymph nodes
examined pathologically (groin dissection, 6 nodes; axillary dissection 12 nodes;
neck dissection 15 nodes).

- Patients must be adequately recovered from surgery, radiation therapy, or any
surgical complications prior to enrollment. In general, this means patients will be
off antibiotics from wound infections and drains removed. However, if necessary,
patients can be treated with a drain in place at the discretion of the PI if the 6
week window is about to expire.

- Histologic proof of melanoma reviewed and confirmed by MSKCC.

- A documented BRAFV600E or BRAFV600K mutation by genotyping or IHC [35]performed by a
CLIA certified laboratory.

- Age ≥ 18 years old

- ECOG performance status = 0 or Karnofsky Performance Status equivalent

- The ability to swallow pills.

- Patients must have adequate organ and marrow function as defined below:

Absolute neutrophil count ≥1.5 K/mcL Platelets ≥ 100 K/mcL Hemoglobin ≥ 9.0 g/dL Total
bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)

≤ 3.0 X institutional ULN if the patient has Gilbert's Syndrome AST (SGOT) and ALT (SGPT)
≤ 2.5 X institutional ULN Creatinine ≤ 1.5 X institutional ULN or creatinine clearance
(calculated or measured) > 60 ml/min

- Women with child bearing potential and men with reproductive potential must be
willing to practice acceptable methods of contraception.

Exclusion Criteria:

- Patients with a history of stage III melanoma (any primary melanoma with locoregional
nodal/subcutaneous disease) treated with surgical resection who subsequently have
disease recurrence meeting the criteria for stage IIIC disease.

- Prior therapy with ipilimumab, other BRAF inhibitors, or MEK inhibitors.

- Concurrent adjuvant immunotherapy, chemotherapy, or radiotherapy.

- Current use of a prohibited medication while on dabrafenib

- Presence of active gastrointestinal disease or other condition that will interfere
significantly with the absorption of drugs.

- A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.

- Pregnant women and lactating women.

- A concurrent second malignancy even if it does not require active therapy. Patients
with indolent B-cell malignancies will not be eligible. Prior malignancy will be
allowed as long as the patient is known to be free of disease for at least 5 years.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- QTc interval > 500 msec.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine the Relapse free survival

Outcome Description:

Relapse free survival is defined as the time from the initiation of adjuvant dabrafenib to the first recurrence or death as assessed by physical examination and radiographic evaluation. All recurrences will be confirmed by biopsy and histologic evaluation.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Paul Chapman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Melanoma
  • Dabrafenib
  • (GSK2118436)
  • BRAFV600E/K
  • Resected AJCC Stage IIIC
  • 12-124
  • Melanoma



Memorial Sloan Kettering Cancer Center New York, New York  10021