Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006434

Trial Description

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Title

A Phase II, Randomized Study of Atezolizumab Administered as Monotherapy or In Combination With Bevacizumab Versus Sunitinib In Patients With Untreated Advanced Renal Cell Carcinoma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This multicenter, randomized, open-label study will evaluate the efficacy and safety of
atezolizumab as monotherapy or in combination with Avastin (bevacizumab) versus sunitinib in
patients with previously untreated locally advanced or metastatic renal cell carcinoma.
Patients in Arm A will receive atezolizumab 1200 mg IV every 3 weeks (6-week cycles) plus
Avastin 15 mg/kg IV until disease progression. Patients in Arm B will receive atezolizumab
alone (until disease progression), 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
progression, patients in Arms B and C will be given the option to receive combination
treatment with atezolizumab and Avastin.

Patients enrolled into arm B (atezolizumab alone) in Europe (including France, Italy, the
United Kingdom, Romania, Spain, Germany, the Czech Republic and Poland) are not eligible to
cross over into arm A to receive combination treatment with atezolizumab and bevacizumab
following disease progression, per local regulatory requirement.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006434
  •   2014/12/02
  •   2013/11/07
  •   no
  •   [---]*
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Secondary IDs

  •   2013-003167-58 
  •   NCT01984242  (ClinicalTrials.gov)
  •   WO29074  (Hoffmann-La Roche)
  •   2013-003167-58 
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Health Condition or Problem studied

  •   Renal Cell Carcinoma
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
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Interventions/Observational Groups

  •   Drug: atezolizumab
  •   Drug: atezolizumab
  •   Drug: bevacizumab [Avastin]
  •   Drug: bevacizumab [Avastin]
  •   Drug: sunitinib
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Progression-free survival per RECIST v.1.1 via central IRC assessment; time frame: Up to 2.5 years

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Secondary Outcome

- Progression-free survival using investigator assessment per immune-related criteria; time frame: Up to 2.5 years
- Overall response rate (complete + partial response); time frame: Up to 2.5 years
- Duration of response; time frame: approximately 2.5 years
- Overall survival; time frame: Up to 2.5 years
- Overall response rate in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to atezolizumab + Avastin treatment; time frame: Up to 1.5 years
- Duration of response in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to atezolizumab + Avastin treatment; time frame: approximately 1.5 years
- Progression-free survival in patients progressing on the sunitinib and MPDL alone arms who subsequently cross over to atezolizumab + Avastin treatment; time frame: Up to 1.5 years
- Safety: Incidence of adverse events; time frame: approximately 2.5 years
- Pharmacokinetics of atezolizumab alone and in combination with bevacizumab: Area under the concentration-time curve; time frame: Cycle 1

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Countries of Recruitment

  •   United States
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Poland
  •   Romania
  •   Spain
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/01/31
  •   300
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 atezolizumab or Avastin (bevacizumab) for patients
randomized to Arm A, or at least 90 days after the last dose of atezolizumab
monotherapy for patients randomized to Arm B, or at least 30 days after the last dose
of sunitinib for patients randomized to Arm C.

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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 active malignancies or metastasis of the brain or spinal cord or leptomeningeal
disease, as determined by CT or MRI evaluation during screening and prior
radiographic assessments

- 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

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.