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A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA


Inclusion Criteria:



- Patients with histologically confirmed melanoma, either unresectable stage IIIc or
stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer
7th edition.

- Unresectability of stage IIIc disease must have confirmation from a surgical
oncologist.

- Patients must be naïve to treatment for locally advanced unresectable or metastatic
disease (i.e., no prior systemic anti-cancer therapy for advanced disease; stage IIIc
and IV). Prior adjuvant immunotherapy (including ipilimumab) is allowed.

- Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival
or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test.

- Measurable disease per RECIST v1.1.

- Eastern Clinical Oncology Group performance status of 0 or 1.

- Consent to provide archival for biomarker analyses.

- Consent to undergo tumor biopsies for biomarker analyses.

- Life expectancy >/= 12 weeks.

- Adequate hematologic and end organ function

Exclusion Criteria:

- History of prior RAF or MEK pathway inhibitor treatment.

- Palliative radiotherapy within 14 days prior to the first dose of study treatment.

- Major surgery or traumatic injury within 14 days prior to first dose of study
treatment.

- Active malignancy other than melanoma that could potentially interfere with the
interpretation of efficacy measures. Patients with a previous malignancy within the
past 3 years are excluded except for patients with resected basal cell carcinoma
(BCC) or squamous cell carcinoma (SCC) of the skin, melanoma in-situ, carcinoma
in-situ of the cervix, and carcinoma in-situ of the breast.

- History of or evidence of retinal pathology on ophthalmologic examination that is
considered a risk factor for neurosensory retinal detachment, retinal vein occlusion
(RVO), or neovascular macular degeneration.

- Uncontrolled glaucoma with intra-ocular pressures

- Serum cholesterol >/= Grade 2

- Hypertriglyceridemia >/= Grade 2

- Hyperglycemia (fasting) >/= Grade 2

- History of clinically significant cardiac dysfunction

- Patients with active CNS lesions (including carcinomatous meningitis) are excluded.
However, patients are eligible if:

1. All known CNS lesions have been treated with stereotactic therapy or surgery,
AND

2. There has been no evidence of clinical and radiographic disease progression in
the CNS for >/= 3 weeks after radiotherapy or surgery

- Current severe, uncontrolled systemic disease.

- History of malabsorption or other condition that would interfere with absorption of
study drugs.

- Pregnant, lactating, or breast feeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival according to Response Evaluation Criteria in Solid Tumors v1.1

Outcome Time Frame:

Approximately 5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

GO28141

NCT ID:

NCT01689519

Start Date:

January 2013

Completion Date:

August 2016

Related Keywords:

  • Malignant Melanoma
  • BRAF positive melanoma
  • Genentech BRAF inhibitor
  • Roche MEK inhibitor
  • RG7204
  • vemurafenib
  • Oncogenic BRAF inhibitor
  • metastatic melanoma
  • advanced melanoma
  • GDC-0973
  • PLX4032
  • Roche BRAF inhibitor
  • melanoma
  • Genentech RAF inhibitor
  • Genentech MEK inhibitor
  • RO5185426
  • XL518
  • Zelboraf
  • Roche RAF inhibitor
  • BRAF V600E kinase inhibitor
  • BRAF mutant melanoma
  • BRAF kinase inhibitor
  • Melanoma

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Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
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Little Rock, Arkansas  72205-7199
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