Study of Pembrolizumab and Ramucirumab in Pts With Progressive TCC After Treatment With an Immune Checkpoint Inhibitor
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|ClinicalTrials.gov Identifier: NCT04179110|
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Transitional Cell Carcinoma||Drug: Pembrolizumab and Ramucirumab||Phase 2|
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:
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Pembrolizumab and Ramucirumab in Patients With Progressive Transitional Cell Carcinoma After Treatment With an Immune Checkpoint Inhibitor|
|Actual Study Start Date :||September 18, 2020|
|Estimated Primary Completion Date :||December 15, 2022|
|Estimated Study Completion Date :||June 15, 2023|
Experimental: Pembrolizumab and Ramucirumab
Patients with progressive transitional cell carcinoma after treatment with an immune checkpoint inhibitor will receive Pembrolizumab and Ramucirumab.
Drug: Pembrolizumab and Ramucirumab
Patients will receive Pembrolizumab 200 mg & Ramucirumab 10 mg/kg every 3 weeks.
- Overall response rate (ORR) [ Time Frame: Up to 24 months ]The objective overall response rate (ORR) is the proportion of enrolled patients who have received any amount of either study drug, have at least 1 post baseline tumor image, and achieve a best overall response of complete response (CR) or partial response (PR). The ORR will be assessed based on RECIST 1.1 and irRECIST.
- Progression free survival (PFS) [ Time Frame: Up to 24 months ]Progression-free survival (PFS) is defined as the time from the date of first study treatment until the date of the first observed radiographically documented PD or death due to any cause, whichever is earlier.
- Overall survival (OS) [ Time Frame: Up to 24 months ]Overall survival (OS), including 1- and 2- year survival rates, is determined from the date of first study treatment until death due to any cause. If the patient was alive at the data inclusion cutoff date for the analysis (or was lost to follow-up), OS will be censored on the last date the patient was known to be alive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179110
|Contact: Matthew Piscatelli, BS||(203) firstname.lastname@example.org|
|Contact: Michael Hurwitz, PhD, MDemail@example.com|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|Contact: Michael Hurwitz|
|Principal Investigator: Michael Hurwitz|
|Principal Investigator:||Michael Hurwitz, PhD, MD||Assistant Professor of Medicine (Medical Oncology) Yale University|