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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR ZELBORAF

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Clinical Trials for Zelboraf

Trial ID Title Status Sponsor Phase Summary
NCT01495988 Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma Terminated Genentech, Inc. Phase 2 This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1) standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood vessel formation and can stimulate the immune system. Previous clinical studies in melanoma have shown that bevacizumab may improve clinical benefit (progression free survival) if combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior therapies, excluding BRAF and MEK inhibitors.
NCT01495988 Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma Terminated Melanoma Research Foundation Breakthrough Consortium Phase 2 This phase 2 clinical trial randomizes patients with BRAF mutant melanoma to either (1) standard of care (SOC) - BRAF inhibitor vemurafenib in combination with MEK inhibitor cobimetinib; or, (2) SOC plus bevacizumab, an anti-VEGF antibody that suppresses new blood vessel formation and can stimulate the immune system. Previous clinical studies in melanoma have shown that bevacizumab may improve clinical benefit (progression free survival) if combined with ipilimumab or abraxane. Preclinical studies suggest that VEGF increase plays a role in resistance to BRAF inhibitors. This randomized study will ask whether the addition of bevacizumab to targeted therapy SOC in BRAF mutant melanoma can improve response rates and clinical benefit. Patients may have received no therapy for advanced disease or up to 2 prior therapies, excluding BRAF and MEK inhibitors.
NCT01519323 BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations Terminated Hoffmann-La Roche Phase 1 This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.
NCT01524978 A Study of Zelboraf (Vemurafenib) in Patients With BRAF V600 Mutation-Positive Cancers Active, not recruiting Hoffmann-La Roche Phase 2 This open-label, multi-center study will assess the efficacy and safety of Zelboraf (vemurafenib) in patients with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom Zelboraf is deemed the best treatment option in the opinion of the investigator. Patients will receive twice daily oral doses of 960 mg Zelboraf until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of Zelboraf in combination with cetuximab in a subset of patients with colorectal cancer will also be assessed.
NCT01586195 Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E Terminated Genentech, Inc. Phase 2 This is an open-label, multicenter, single-agent, phase II study of continuous oral Zelboraf (vemurafenib) in patients with locally-advanced, unresectable, stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E.
NCT01596140 Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer Active, not recruiting M.D. Anderson Cancer Center Phase 1 The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with either everolimus or temsirolimus. The safety of these drug combinations will also be studied. Vemurafenib is designed to block BRAF inside the cancer cells, which is a mutation that is involved in cancer cell growth. Temsirolimus and everolimus are designed to block the growth of cancer cells, which may cause cancer cells to die.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Zelboraf

Condition Name

Condition Name for Zelboraf
Intervention Trials
Melanoma 7
Malignant Melanoma 6
Metastatic Melanoma 5
Malignant Melanoma Stage IV 2
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Condition MeSH

Condition MeSH for Zelboraf
Intervention Trials
Melanoma 27
Neoplasm Metastasis 4
Lymphoma 3
Neoplasms 3
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Clinical Trial Locations for Zelboraf

Trials by Country

Trials by Country for Zelboraf
Location Trials
United States 198
Italy 24
Spain 16
Australia 8
Germany 8
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Trials by US State

Trials by US State for Zelboraf
Location Trials
California 12
Texas 12
New York 12
Tennessee 11
Pennsylvania 11
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Clinical Trial Progress for Zelboraf

Clinical Trial Phase

Clinical Trial Phase for Zelboraf
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 20
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Clinical Trial Status

Clinical Trial Status for Zelboraf
Clinical Trial Phase Trials
Recruiting 11
Active, not recruiting 9
Terminated 8
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Clinical Trial Sponsors for Zelboraf

Sponsor Name

Sponsor Name for Zelboraf
Sponsor Trials
Hoffmann-La Roche 9
Genentech, Inc. 8
National Cancer Institute (NCI) 5
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Sponsor Type

Sponsor Type for Zelboraf
Sponsor Trials
Other 32
Industry 26
NIH 5
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