A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma - Randomized Trial of Pembrolizumab with or without Chemo vs Chemo in Advanced Urothelial Carcinoma

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites990 target enrollmentAugust 9, 2016

ConditionsAdvanced or Metastatic Urothelial Carcinoma MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsGemcitabine Cisplatin Teva® 1mg/ml Carboplatin Actavis 10mg/ml

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced or Metastatic Urothelial Carcinoma
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 990
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 9, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Have a histologically or cytologically confirmed diagnosis of advanced/unresectable or metastatic urothelial carcinoma of the renal pelvis, ureter \[upper urinary tract], bladder, or urethra. Both transitional cell and mixed transitional/nontransitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
•2\. Have measurable disease based on RECIST 1\.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
•3\. Voluntarily agree to participate by providing written informed consent/assent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•4\. Be \=18 years of age on the day of signing informed consent.
•5\. Have received no prior systemic chemotherapy for advanced or metastatic urothelial carcinoma, with the following exceptions:
•a. Neoadjuvant platinum\-based chemotherapy with recurrence \>12 months from completion of therapy is permitted.
•b. Adjuvant platinum\-based chemotherapy following radical cystectomy with recurrence \>12 months from completion of therapy is permitted.
•6\. Have provided tissue for biomarker analysis from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated from a muscle invasive urothelial carcinoma or a metastatic biopsy, originating from the original tumor. A newly obtained biopsy is strongly preferred but not required if archival tissue is evaluable. If submitting unstained cut slides, freshly cut slides should be submitted to the testing laboratory within 14 days from when the slides are cut. Refer to Section 7\.1\.2\.12 in the protocol for an explanation. PDL1 status (CPS \=10% or CPS \<10%) must be determined by the central laboratory during the screening period prior to enrollment.
•7\. Have an ECOG PS of 0, 1, or 2\.
•8\. Demonstrate adequate organ function as defined in the protocol

Exclusion Criteria

•1\. Has disease that is suitable for local therapy administered with curative intent.
•2\. Is currently participating and receiving study therapy.
•3\. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
•4\. Has an active autoimmune disease that has required systemic treatment in the past 2 years.
•5\. Has had a prior anticancer mAb for direct antineoplastic treatment within 4 weeks prior to the first dose of trial treatment (6 weeks for nitrosoureas or mitomycin C) or who has not recovered (ie, \=Grade 1 or at baseline) from AEs due to mAbs administered more than 4 weeks earlier.
•6\. Has not recovered from AEs due to a previously administered agent.
•7\. Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
•8\. Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis.
•9\. Has a known history of active tuberculosis (TB) (Bacillus tuberculosis).
•10\. Has an active infection requiring systemic therapy.