Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT02437370|
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter Recurrent Bladder Carcinoma Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter Regional Urothelial Carcinoma of the Renal Pelvis and Ureter Stage III Bladder Urothelial Carcinoma Stage III Urethral Cancer Stage IV Bladder Urothelial Carcinoma Stage IV Urethral Cancer Urethral Urothelial Carcinoma||Drug: Pembrolizumab Drug: Docetaxel Drug: Gemcitabine Hydrochloride||Phase 1|
I. To evaluate the safety and tolerability of MK-3475 (pembrolizumab) when given in combination with docetaxel or gemcitabine (gemcitabine hydrochloride) in patients with advanced or metastatic platinum-treated urothelial cancer.
I. To assess in a preliminary manner the efficacy of this combination (overall response rate and progression free survival).
II. To determine in an exploratory manner programmed death (PD)-ligand (L)1 expression in archival tumor specimens and to correlate this with patient outcomes.
OUTLINE: This is a dose-escalation study of pembrolizumab. Patients are assigned to 1 of 2 treatment arms. (Patients who had received prior gemcitabine hydrochloride/cisplatin or gemcitabine hydrochloride/carboplatin [GC] or methotrexate, vinblastine sulfate, adriamycin, and cisplatin [MVAC] therapy are assigned to Arm A).
ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and docetaxel IV over 60 minutes on day 1.
ARM B: Patients receive pembrolizumab IV as in Arm A and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8.
In both arms, treatment repeats every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Trial of MK3475 + Docetaxel or Gemcitabine in Platinum Pre-treated Urothelial Cancer|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Arm A (pembrolizumab, docetaxel)
pembrolizumab IV over 30 minutes on day 1 and docetaxel IV over 60 minutes on day 1.
Experimental: Arm B (pembrolizumab, gemcitabine hydrochloride)
pembrolizumab IV as in Arm A and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8.
Drug: Gemcitabine Hydrochloride
- Maximum tolerated dose of pembrolizumab based on the incidence of dose limiting toxicity, defined as the Incidence of adverse events, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 6 months post-treatment ]Will be summarized descriptively by tables of numbers and percent of patients experiencing adverse events, overall and by type, grade, seriousness, duration, action taken, and assessment of relation to pembrolizumab or docetaxel or gemcitabine hydrochloride.
- Overall response rate (ORR), assessed using the RECIST version 1.1 [ Time Frame: Up to 6 months post-treatment ]The number and proportion experiencing complete response, partial response, stable disease, or progressive disease will be summarized separately for each study arm.
- Progression free survival (PFS) [ Time Frame: Time from enrollment to the first occurrence of disease progression, as determined by RECIST v1.1, or death from any cause, assessed up to 6 months post-treatment ]Will be summarized graphically by Kaplan-Meier curves and descriptively by a corresponding life-table approach to allow for possible censored data.
- PD-L1 expression [ Time Frame: Baseline ]The relation of PD-L1 expression at baseline to outcome (ORR and PFS) will be summarized descriptively in exploratory analyses, separately for each study arm. Descriptive associations with ORR will be summarized by the means and standard deviations for responders vs. non-responders, and graphically by dot plots of PD-L1 expression for responders and non-responders. Descriptive associations with PFS will be summarized by Kaplan-Meier plots comparing PFS for high and low PD-L1 expression.
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): NCT02437370
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Primo N. Lara 916-734-3771 firstname.lastname@example.org|
|Principal Investigator: Primo N. Lara|
|Principal Investigator:||Primo Lara||University of California, Davis|