A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

I4T-MC-JVDF -

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.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Esophageal Cancer, Lung Cancer, Bile Duct Cancer, Stomach Cancer, Urothelial Cancer, Bladder Cancer, Kidney Cancer
What the trial is testing?
Ramucirumab, Pembrolizumab
Could I receive a Placebo?
No
Enrollment Goal
175
Trial Dates
Jul 29, 2015 - Apr 12, 2022
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.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

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

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