Recent Updates
Recently added Catalysts

Anti-PDL-1 antibody

Phase 1

Cancer, Multiple Indications | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 7, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment281
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00729664Multiple Ascending Dose (MDX1105-01)PHASE1 COMPLETED 281Feb 1, 2009Jul 1, 2015Sep 7, 201511 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety, maximum tolerated dose (MTD) and dose-limiting toxicity(DLT)of MDX-1105
Weekly
Secondary Endpoints
Preliminary efficacy in solid tumors on the basis of objective responses
Day 42
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Anti-PDL-1 antibody (Arm 1)EXPERIMENTALBMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 2)EXPERIMENTALBMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 3)EXPERIMENTALBMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 4)EXPERIMENTALBMS-936559 (MDX-1105)
Anti-PDL-1 antibody (Arm 5)EXPERIMENTALBMS-936559 (MDX-1105)
Interventions
NameTypeDescription
Anti-PDL-1 antibodyBIOLOGICALSolution, Intravenous, 0.1 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles/48 doses depending on response
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 * The malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pa...

Countries:United States
Unlock Eligibility Criteria