Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02581982|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : September 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Transitional Cell Carcinoma||Other: Laboratory Biomarker Analysis Drug: Paclitaxel Biological: Pembrolizumab||Phase 2|
I. To estimate the overall response rate (ORR) of pembrolizumab combined with paclitaxel.
I. To determine the safety and tolerability of pembrolizumab combined with paclitaxel.
II. To calculate the progression-free survival (PFS) rate at 6 months.
I. To determine the immune effects of pembrolizumab combined with paclitaxel. II. To associate immune effects with tumor response. III. To explore changes in immune-regulatory micro ribonucleic acids (RNAs) as biomarkers of response.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days and then every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Arm Phase II Combination Study of Low-Dose Paclitaxel With Pembrolizumab in Platinum-Refractory Urothelial Carcinoma|
|Actual Study Start Date :||April 6, 2016|
|Actual Primary Completion Date :||May 11, 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: Treatment (pembrolizumab, paclitaxel)
Patients receive pembrolizumab IV over 30 minutes on day 1 and paclitaxel IV over 60 minutes on day 1 and 8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall Response Rate [ Time Frame: Up to 6 months ]The overall response rate will be performed in all patients that are evaluable for efficacy and will have one interim analysis.
- Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 year ]All adverse events will be tabulated and presented by preferred term and/or system organ class and grade. All deaths and serious adverse events will be tabulated.
- Progression Free Survival [ Time Frame: At 6 months ]The Kaplan Meier methods will be used to estimate progression free survival. The 6-month PFS will be compared to historical rates using a chi-square test.
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): NCT02581982
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Michael Goodman, MD||Wake Forest University Health Sciences|