Completed

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
Email
Completed

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
Email

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

Could I receive a Placebo?

no

Enrollment Goal

167

Trial Dates

July 2015 - December 2019

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

Could I receive a Placebo?

no

Enrollment Goal

167

Trial Dates

July 2015 - December 2019

Trial Phase

1

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?