Active not recruiting
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC or Transitional Cell Carcinoma of the Urothelium
I4T-MC-JVDF - ClinicalTrials.gov - NCT02443324
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug, known as ramucirumab, plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or transitional cell carcinoma of the urothelium.
How long will I be in the trial?
Participation in this trial could last up to 6 months, depending on how you and your tumor respond
Active not recruiting
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC or Transitional Cell Carcinoma of the Urothelium
I4T-MC-JVDF - ClinicalTrials.gov - NCT02443324
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug, known as ramucirumab, plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or transitional cell carcinoma of the urothelium.
How long will I be in the trial?
Participation in this trial could last up to 6 months, depending on how you and your tumor respond
Key Requirements
Age :
18+
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18+
Sex
All
Participants must
Participant must have confirmed gastric or GEJ adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy or
Participant must have confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 prior lines of systemic therapy or
Participant must have confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
Participant must have tumor tissue available for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy
Participant must have adequate organ function
Participants must NOT
Participant must not have known brain metastases
Participant must not have active autoimmune disease, known HIV infection, or known active hepatitis B or hepatitis C infection
Participant must not have an elective or planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment
Trial Summary
Conditions the trial is for
Non-small Cell Lung Cancer, Gastroesophageal Junction Cancer (GEJ), Transitional Cell Cancer, Stomach Cancer
What the trial is testing?
Ramucirumab, Pembrolizumab
Could I receive a Placebo?
no
Enrollment Goal
167
Trial Dates
July 2015 - May 2021
Trial Phase
1
Enter your postal code to find the nearest site
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18+
Sex
All
Participants must
Participant must have confirmed gastric or GEJ adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy or
Participant must have confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 prior lines of systemic therapy or
Participant must have confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
Participant must have tumor tissue available for biomarker analysis from a newly obtained core or excisional biopsy or willing to undergo a tumor biopsy
Participant must have adequate organ function
Participants must NOT
Participant must not have known brain metastases
Participant must not have active autoimmune disease, known HIV infection, or known active hepatitis B or hepatitis C infection
Participant must not have an elective or planned major surgery during the course of the trial or has undergone major surgery within 28 days prior to enrollment
Trial Summary
Conditions the trial is for
Non-small Cell Lung Cancer, Gastroesophageal Junction Cancer (GEJ), Transitional Cell Cancer, Stomach Cancer
What the trial is testing?
Ramucirumab, Pembrolizumab
Could I receive a Placebo?
no
Enrollment Goal
167
Trial Dates
July 2015 - May 2021
Trial Phase
1
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Trial Locations
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