Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 4 of 23 for:    MPDL3280A

A Study of MPDL3280A Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02302807
First received: November 25, 2014
Last updated: March 2, 2015
Last verified: March 2015
  Purpose

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of MPDL3280A compared with chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 767 patients.


Condition Intervention Phase
Bladder Cancer
Drug: Chemotherapy
Drug: MPDL3280A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Between randomization and death due to any cause, up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]
  • Duration of response (DOR) [ Time Frame: Up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies to MPDL3280A [ Time Frame: Up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) of MPDL3280A [ Time Frame: Up to approximately 23 months after first patient enrolled ] [ Designated as safety issue: No ]

Estimated Enrollment: 767
Study Start Date: January 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: MPDL3280A Drug: MPDL3280A
MPDL3280A, 1200 mg by intravenous infusion on Day 1 of each 21-day cycle
Active Comparator: Arm B: Control Chemotherapy
Prior to randomization, the investigator will have the option of choosing one of three chemotherapy regimens (vinflunine, paclitaxel, or docetaxel) for each patient. The ratio of patients who are randomized to vinflunine versus patients who are randomized to a taxane (paclitaxel or docetaxel) will be approximately 1:1
Drug: Chemotherapy
vinflunine, paclitaxel, or docetaxel per the investigator's choice and administered according to local label

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/= 18 years
  • Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
  • Representative tumor specimens as specified by the protocol
  • Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy >/= 12 weeks
  • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Adequate hematologic and end organ function
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception as defined by the protocol and to continue its use for 6 months after the last dose of MPDL3280A

Exclusion Criteria:

  • Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
  • Leptomeningeal disease
  • Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
  • Pregnant and lactating women
  • Significant cardiovascular disease
  • Severe infections within 4 weeks prior to randomization
  • Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplant
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks prior to randomization
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02302807

Contacts
Contact: Reference Study ID Number: GO29294 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 213 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02302807     History of Changes
Other Study ID Numbers: GO29294, 2014-003231-19
Study First Received: November 25, 2014
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on March 02, 2015