NCT04179110

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Transitional Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab and Ramucirumab	Patients will receive Pembrolizumab 200 mg \& Ramucirumab 10 mg/kg every 3 weeks.

Timeline

• Start date: 2020-09-18
• Primary completion: 2022-12-15
• Completion: 2023-06-15
• First posted: 2019-11-27
• Last updated: 2022-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study