The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Administered IV
Administered IV
UCLA Medical Center
Santa Monica, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University Medical Center
St Louis, Missouri, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Miriam Hospital
Providence, Rhode Island, United States
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (up to 28 days)
Percentage of Participants with a Best Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Time frame: Baseline to Disease Progression (Approximately 22 Months)
Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Time frame: Baseline to Disease Progression (Approximately 22 Months)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 22 Months)
Time to First Response (TTR)
Time frame: Baseline to Date of CR or PR (Approximately 22 Months)
Progression Free Survival (PFS)
Time frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 22 Months)
Overall Survival (OS)
Time frame: Baseline to Progressive Disease or Death from Any Cause (Approximately 32 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab and MEDI4736
Time frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)
PK: Minimum Concentration (Cmin) of Ramucirumab and MEDI4736
Time frame: Predose Cycle 1 Day 1 through Follow up (Approximately 22 Months)
Number of Participants with Treatment Emergent Anti Ramucirumab Antibodies
Time frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)
Number of Participants with Treatment Emergent Anti MEDI4736 Antibodies
Time frame: Predose Cycle 1 Day 1 through Follow Up (Approximately 22 Months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Besançon, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Marseille, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montpellier, France
...and 18 more locations