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| ID | Type | Description | Link |
|---|---|---|---|
| CA184-058 | |||
| AVF 4122s |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab Plus Ipilimumab Cohort 1 | Experimental | 5 subjects for this cohort |
|
| Bevacizumab Plus Ipilimumab Cohort 2 | Experimental | 17 subects for this cohort |
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| Bevacizumab Plus Ipilimumab Cohort 3 | Experimental | 12 subjects |
|
| Bevacizumab Plus Ipilimumab Cohort 4 | Experimental | 12 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Plus Ipilimumab Cohort 1 | Drug | Cohort 1: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous) |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety, tolerability and maximum tolerated dosing for the combination of bevacizumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the best overall response rate by standard solid tumor response criteria, disease control rate, time to tumor progression, and duration of response for the combination of bevacizumab plus ipilimumab in this patient population | 3 years | |
| To perform correlative studies investigating the effects of this combination therapy on antitumor immunity and tumor vasculature |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F. Stephen Hodi, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
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| Bevacizumab Plus Ipilimumab Cohort 2 | Drug | Cohort 2: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous) |
|
|
| Bevacizumab Plus Ipilimumab Cohort 3 | Drug | Cohort 3: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous) |
|
|
| Bevacizumab Plus Ipilimumab Cohort 4 | Drug | Cohort 4: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous) |
|
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| 3 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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