A Study of Atezolizumab in Advanced Solid Tumors
Part of paid clinical trials in New York, New York.
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT02458638
- Phase
- PHASE2
- Status
- Completed
Conditions
- Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody — DRUGAtezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
Study Details
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.
Key Dates
- Start date
- Jul 16, 2015
- Status verified
- May 2021
- Primary completion
- Apr 4, 2018
- Completion
- Jul 28, 2020
Study Design
- Enrollment
- 474 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: AtezolizumabThe dose of atezolizumab in this study will be 1200 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Primary Outcome Measure
Non-progression Rate (NPR) at 18 Weeks [ Time Frame: At Week 18 ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10027 | - |
| Memorial Sloan Kettering | New York | New York | 10065 | - |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | - |
| Sarah Cannon Cancer Center and Research Institute | Nashville | Tennessee | 37203 | - |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
Find similar trials in New York, NY
Related Studies
- Assessment of Functional and Symptom Outcomes for Survivors of Paranasal Sinus, Nasopharyngeal and Skull Base TumorsRecruiting · M.D. Anderson Cancer Center · Houston, Texas
- XACT ACE Observational RegistryRecruiting · Xact Robotics Ltd. · Burlington, Massachusetts
- HP Pyruvate MRI in CancersPHASE1/PHASE2 · Recruiting · University of Maryland, Baltimore · Baltimore, Maryland