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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02108652
First received: April 7, 2014
Last updated: November 24, 2014
Last verified: November 2014

April 7, 2014
November 24, 2014
May 2014
November 2015   (final data collection date for primary outcome measure)
Objective response rate (ORR) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02108652 on ClinicalTrials.gov Archive Site
  • Duration of response (DOR) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies to MPDL3280A [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) of MPDL3280A [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of MPDL3280A in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This phase II, single-arm study was designed to evaluate the effect of MPDL3280A treatment in patients with locally advanced or metastatic urothelial bladder ca ncer. Patients will be enrolled into 1 of 2 cohorts. Cohort 1 will consist of pa tients who are treatment-naïve and ineligible for platinum-containing therapy. C ohort 2 will contain patients who have progressed during or following a prior pl atinum-based chemotherapy regimen. Patients in both cohorts will be given a 1200 mg intravenous (IV) dose of MPDL3280A on Day 1 of 21-day cycles. Treatment may continue for up to 16 cycles or 12 months, whichever is first, in the absence of toxicity or disease progression. Patients will be followed for up for 2 years. Patients who complete the initial treatment stage of up to 16 cycles may be eli gible for MPDL3280A re-treatment upon subsequent disease progression during the follow-up period and without intervening systemic anti-cancer therapy.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Transitional Cell , Bladder Cancer, Bladder Tumors, Urinary Bladder Neoplasms
Drug: MPDL3280A
1200 mg dose given by intravenous infusion (IV) on Day 1 of 21-day cycles for up to 16 cycles or 12 months (whichever comes first)
  • Experimental: Cohort 1
    Treatment-naive and cisplatin-ineligible patients
    Intervention: Drug: MPDL3280A
  • Experimental: Cohort 2
    Patients with disease progression following or during platinum-containing treatment
    Intervention: Drug: MPDL3280A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
March 2016
November 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >/= 18 years
  • Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
  • Representative tumor specimens as specified by the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy >/= 12 weeks
  • Measurable disease, as defined by RECIST v1.1
  • Adequate hematologic and end organ function

Cohort 1-Specific Inclusion Criteria

  • Ineligible for cisplatin-based chemotherapy due to one of the following:
  • Impaired renal function
  • A hearing loss of 25 dB at two contiguous frequencies
  • Grade 2 or greater peripheral neuropathy
  • ECOG performance score of 2

Cohort 2-Specific Inclusion Criteria

  • Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence

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 CT or 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 treated with expected curative outcome or incidental prostate cancer
  • Pregnant and lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Serum albumin < 2.5 g/dL
  • Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
  • Severe infections within 4 weeks prior to Cycle 1, Day 1
  • Significant cardiovascular disease
  • Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
  • Prior allogeneic stem cell or solid organ transplant
  • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Both
18 Years and older
No
Contact: Reference Study ID Number: GO29293 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT02108652
GO29293
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP