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Completed Phase 1 Interventional Results available

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)

ClinicalTrials.gov ID: NCT01772004

Public ClinicalTrials.gov record NCT01772004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 .

Study identification

NCT ID
NCT01772004
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
1,756 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 30, 2013
Primary completion
Dec 15, 2019
Completion
Dec 15, 2019
Last update posted
Dec 19, 2021

2013 – 2019

United States locations

U.S. sites
53
U.S. states
23
U.S. cities
48
Facility City State ZIP Site status
Cancer Treatment Centers of America - Western Regional Medical Center Goodyear Arizona 85338
Scottsdale Healthcare Corporation Scottsdale Arizona 85258-4550
Pinnacle Oncology Hematology Scottsdale Arizona 85258
Highlands Oncology Group Rogers Arkansas 72758
Pacific Cancer Medical Center, Inc. Anaheim California 92801
California Cancer Associates for Research & Excellence, Inc Encinitas California 92024
Healing Hands Oncology and Medical Care Inglewood California 90305
Scripps Health dba Scripps Clinical Research Services La Jolla California 92037
The Angeles Clinic and Research Institute - West LA Los Angeles California 90025
Cedars-Sinai Medical Center - Oncology Los Angeles California 90048
University of California Davis Health System Sacramento California 95817
Sharp Memorial Hospital San Diego California 92123
Georgetown University Medical Center- Research Parent Washington D.C. District of Columbia 20057
Holy Cross Hospital Fort Lauderdale Florida 33308
University of Miami Miami Florida 33136
Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast Port Saint Lucie Florida 34952
Florida Cancer Specialists Sarasota Florida 34232
Northeast Georgia Cancer Care, LLC Athens Georgia 30607
Peachtree Hematology-Oncology Consultants, PC Atlanta Georgia 30318
Augusta University - formerly Georgia Regents University Augusta Georgia 30912
Northwest Georgia Oncology Centers PC Marietta Georgia 30060
University of Chicago Medical Center Chicago Illinois 60637
Horizon Oncology Research, INC Lafayette Indiana 47905
The Johns Hopkins Hospital Baltimore Maryland 21287-7049
RCCA MD LLC - Bethesda Bethesda Maryland 20817
National Cancer Institute Bethesda Maryland 20892
Maryland Oncology Hematology, P.A. Rockville Maryland 20850
Karmanos Cancer Institute Detroit Michigan 48201
Henry Ford Medical Center Detroit Michigan 48202
Michigan State University Lansing Michigan 48910
Virginia Piper Cancer Institute Minneapolis Minnesota 55407
Kansas City Research Institute, LLC - Phase I Unit Kansas City Missouri 64131
Washington University in St. Louis St Louis Missouri 63110
San Juan Oncology Associates Farmington New Mexico 87401
Columbia University College of Phys & Surgeons New York New York 10032
Montefiore Medical Center PRIME The Bronx New York 10461
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center Huntersville North Carolina 28078
UC Health Clinical Trials Office Cincinnati Ohio 45267-0502
University Hospitals Case Medical Center - Case Comprehensive Cancer Center Cleveland Ohio 44106
OSU - James Comprehensive Cancer Center - Division of Hematology Columbus Ohio 43210-1228
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center - d/b/a The Mark H. Zangmeister Center Columbus Ohio 43219
Oklahoma University Medical Center Oklahoma City Oklahoma 73104
Penn State Univ. Milton S. Hershey Medical Center - MSHMC Cardiology Hershey Pennsylvania 17033
Rhode Island Hospital Providence Rhode Island 02903
Medical University of South Carolina Charleston South Carolina 29245
The West Clinic Germantown Tennessee 38138
Baptist Cancer Center Memphis Tennessee 38120
SCRI - Tennessee Oncology Nashville Tennessee 37203
Texas Oncology, P.A Dallas Texas 75246
Oncology Consultants, P.A. Houston Texas 77030
Texas Oncology, P.A. - Tyler Tyler Texas 75702
Northwest Medical Specialties, PLLC Lakewood Washington 98499-3071

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01772004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 19, 2021 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01772004 live on ClinicalTrials.gov.

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