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A Phase 2 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) as Monotherapy or in Combination With Avastin (Bevacizumab) Compared to Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

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:
NCT01984242
First received: November 7, 2013
Last updated: November 24, 2014
Last verified: November 2014

November 7, 2013
November 24, 2014
January 2014
January 2016   (final data collection date for primary outcome measure)
Progression-free survival per RECIST v.1.1 via central ICR assessment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Progression-free survival per RECIST v.1.1 via central ICR assessment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01984242 on ClinicalTrials.gov Archive Site
  • Progression-free survival using investigator assessment per immune-related criteria [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Overall response rate (complete + partial response) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Overall response rate in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Duration of response in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to MPDL3280A + Avastin treatment [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics of MPDL3280A alone and in combination with bevacizumab: Area under the concentration-time curve [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 2 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) as Monotherapy or in Combination With Avastin (Bevacizumab) Compared to Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
A PHASE II, RANDOMIZED STUDY OF MPDL3280A ADMINISTERED AS MONOTHERAPY OR IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA

This multicenter, randomized, open-label study will evaluate the efficacy and sa fety of MPDL3280A as monotherapy or in combination with Avastin (bevacizumab) ve rsus sunitinib in patients with previously untreated locally advanced or metasta tic renal cell carcinoma. Patients in Arm A will receive MPDL3280A 1200 mg IV ev ery 3 weeks (eight 6-week cycles or up to 1 year) plus Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive MPDL3280A alone (up to 1 ye ar), and patients in Arm C will receive sunitinib 50 mg orally daily for 4 weeks followed by 2 weeks rest until disease progression. Following disease progressi on, patients in Arms B and C will be given the option to receive combination tre atment with MPDL3280A and Avastin.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: MPDL3280A
    1200 mg IV q3w (dosed in 6-week cycles), 8 cycles (or up to 1 year, whichever comes first)
  • Drug: MPDL3280A
    Following disease progression: 1200 mg IV q3w (dosed in 6-week cycles), 8 cycles (or up to 1 year, whichever comes first)
  • Drug: bevacizumab [Avastin]
    15 mg/kg IV q3w (dosed in 6-week cycles), until disease progression
  • Drug: bevacizumab [Avastin]
    Following disease progression: 15 mg/kg IV q3w (dosed in 6-week cycles), until disease progression
  • Drug: sunitinib
    50 mg/day orally for 4 weeks, followed by 2 weeks of rest (dosed on 6-week cycles), until disease progression
  • Experimental: A: MPDL3280A + Avastin
    Interventions:
    • Drug: MPDL3280A
    • Drug: bevacizumab [Avastin]
  • Experimental: B: MPDL3280A; following PD: MPDL3280A + Avastin
    Interventions:
    • Drug: MPDL3280A
    • Drug: MPDL3280A
    • Drug: bevacizumab [Avastin]
  • Active Comparator: C: Sunitinib; following PD: MPDL3280A + Avastin
    Interventions:
    • Drug: MPDL3280A
    • Drug: bevacizumab [Avastin]
    • Drug: sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients >/= 18 years of age
  • Unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
  • Measurable disease, as defined by RECIST v1.1
  • Karnofsky performance score >/= 70
  • Adequate hematologic and end-organ function as defined by protocol
  • Women of childbearing potential and male patients must agree to use adequate methods of contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of MPDL3280A or sunitinib

Exclusion Criteria:

  • Radiotherapy for RCC within 28 days prior to Cycle 1, Day 1 with the exception of: Single-fraction radiotherapy given for the indication of pain control
  • Known malignancies or metastasis of the brain or spinal cord or leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia
  • Malignancies other than RCC 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
  • Life expectancy of < 12 weeks
  • Pregnant and lactating women
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of autoimmune disease (Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study)

Bevacizumab- and Sunitinib-Specific Exclusions:

  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
Both
18 Years and older
No
Contact: Reference Study ID Number: WO29074 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Czech Republic,   France,   Germany,   Italy,   Poland,   Romania,   Spain,   Ukraine,   United Kingdom
 
NCT01984242
WO29074, 2013-003167-58
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