Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
Completed · Phase 1
Conditions studied: Solid Tumors
In brief
This is a Phase 1, open-label, dose-escalation trial of avelumab \[antibody targeting programmed death ligand 1 (anti PD-L1)\] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts. Active cohorts: Escalation revised dosing regimen cohort. Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .
Key facts
- Study ID
- NCT01772004
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 1756
- Starts
- 2013-01-31
- Expected to finish
- 2019-12-16
- Last updated by the study team
- 2021-12-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Scottsdale Healthcare Corporation — Scottsdale, Arizona, United States
- Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
- Highlands Oncology Group — Rogers, Arkansas, United States
- Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
- California Cancer Associates for Research & Excellence, Inc — Encinitas, California, United States
- Healing Hands Oncology and Medical Care — Inglewood, California, United States
- Scripps Health dba Scripps Clinical Research Services — La Jolla, California, United States
- The Angeles Clinic and Research Institute - West LA — Los Angeles, California, United States
- Cedars-Sinai Medical Center - Oncology — Los Angeles, California, United States
- University of California Davis Health System — Sacramento, California, United States
- Sharp Memorial Hospital — San Diego, California, United States
- Georgetown University Medical Center- Research Parent — Washington D.C., District of Columbia, United States
- Holy Cross Hospital — Fort Lauderdale, Florida, United States
- University of Miami — Miami, Florida, United States
- Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- Northeast Georgia Cancer Care, LLC — Athens, Georgia, United States
- Peachtree Hematology-Oncology Consultants, PC — Atlanta, Georgia, United States
- Augusta University - formerly Georgia Regents University — Augusta, Georgia, United States
- Northwest Georgia Oncology Centers PC — Marietta, Georgia, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Horizon Oncology Research, INC — Lafayette, Indiana, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- RCCA MD LLC - Bethesda — Bethesda, Maryland, United States
- Cancer Treatment Centers of America - Western Regional Medical Center — Goodyear, Arizona, United States
Full record on ClinicalTrials.gov
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