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| ID | Type | Description | Link |
|---|---|---|---|
| MDX1105-01 | Other Identifier | BMS |
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Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.
This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1).
The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-PDL-1 antibody (Arm 1) | Experimental | BMS-936559 (MDX-1105) |
|
| Anti-PDL-1 antibody (Arm 2) | Experimental | BMS-936559 (MDX-1105) |
|
| Anti-PDL-1 antibody (Arm 3) | Experimental | BMS-936559 (MDX-1105) |
|
| Anti-PDL-1 antibody (Arm 4) | Experimental | BMS-936559 (MDX-1105) |
|
| Anti-PDL-1 antibody (Arm 5) | Experimental | BMS-936559 (MDX-1105) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PDL-1 antibody | Biological | Solution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 | Weekly | |
| Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105 | Bi-weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary efficacy in solid tumors on the basis of objective responses | Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinic & Research Institute | Los Angeles | California | 90025 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22658128 | Derived | Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2. |
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|
| Anti-PDL-1 antibody | Biological | Solution, Intravenous, 0.3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response |
|
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| Anti-PDL-1 antibody | Biological | Solution, Intravenous, 1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response |
|
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| Anti-PDL-1 antibody | Biological | Solution, Intravenous, 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response |
|
|
| Anti-PDL-1 antibody | Biological | Solution, Intravenous, 10 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response |
|
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| University Of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21231 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| University Of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oncology Consultants, Pa | Houston | Texas | 77024 | United States |
| The University Of Texas | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000627113 | BMS-936559 |
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