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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Genentech Bristol-Myers Squibb |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00790010 |
The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. This study also seeks to investigate whether using both study drugs lengthens the amount of time before the participants melanoma worsens.
Condition | Intervention | Phase |
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Melanoma |
Drug: Ipilimumab Drug: Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I Trial of Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma |
Estimated Enrollment: | 33 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: F. Stephen Hodi, MD | 617-632-5053 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02214 |
Principal Investigator: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( F. Stephen Hodi, MD ) |
Study ID Numbers: | 08-142, CA184-058, AVF 4122s |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790010 |
Health Authority: | United States: Food and Drug Administration |
bevacizumab ipilimumab unresectable stage III melanoma unresectable stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Bevacizumab Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |