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Study of Pembrolizumab and Ramucirumab in Pts With Progressive TCC After Treatment With an Immune Checkpoint Inhibitor

Transitional Cell Carcinoma Clinical Trial

Official title:
A Phase II Trial of Pembrolizumab and Ramucirumab in Patients With Progressive Transitional Cell Carcinoma After Treatment With an Immune Checkpoint Inhibitor

Clinical Trial Summary

This study is designed to evaluate response and survival of treatment with the combination of pembrolizumab and ramucirumab in patients with progressive metastatic TCC after immune checkpoint inhibitor treatment.

Clinical Trial Description

This is a phase II, non-randomized single center study designed to evaluate response and survival of treatment with the combination of pembrolizumab and ramucirumab in patients with progressive metastatic TCC after immune checkpoint inhibitor treatment. The primary and secondary objectives are as follows: Primary: - Objective: To evaluate overall response rate (ORR) in patients treated with pembrolizumab and ramucirumab - Hypothesis: The ORR will be ≥15% greater than the historical rate in published literature of patients treated with pembrolizumab alone Secondary Objectives: - Objective: To evaluate progression free survival (PFS) in patients treated with pembrolizumab and ramucirumab - Hypothesis: The PFS will be ≥15% greater than the historical rate in published literature of patients treated with pembrolizumab alone - Objective: To evaluate overall survival (OS) in patients treated with pembrolizumab and ramucirumab - Hypothesis: The OS will be ≥15% greater than the historical rate in published literature of patients treated with pembrolizumab alone - Objective: To evaluate differences in ORR, PFS and OS in patients treated with pembrolizumab and ramucirumab stratified by Bellmunt criteria. - Hypothesis: Patients with high Bellmunt criteria scores will have lower rates of ORR, PFS and OS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04179110
Study type Interventional
Source Yale University
Contact
Status Withdrawn
Phase Phase 2
Start date September 18, 2020
Completion date June 15, 2023
View Details
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