A Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma

Sponsor
Hoffmann-La Roche
Study ID
NCT03693573
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Administration of study drugs will continue until unacceptable toxicity; loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status; investigator or patient decision to withdraw from therapy; or death (whichever occurs first).
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion at 15 mg/kg on Day 1 of each 21-day cycle. Administration of study drugs will continue until unacceptable toxicity; loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status; investigator or patient decision to withdraw from therapy; or death (whichever occurs first).

Study Details

Study MO39939 is an open-label, single-arm, multicenter trial in patients with unresectable, locally-advanced or metastatic, clear or non-clear cell renal cell carcinoma (RCC) who have not received prior systemic therapy (who are treatment naïve in either the \[neo\]adjuvant or advanced/metastatic setting for clear and non-clear cell RCC). The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit occurring approximately 30 days after the last dose of study medication, and a Follow-Up Period of 4 years after last patient enrolled.

Key Dates

First listed
Oct 3, 2018
Start date
Jan 11, 2019
Status verified
Nov 2018
Primary completion
Aug 14, 2021
Completion
Jan 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Bevacizumab
    Participants will receive atezolizumab in combination with bevacizumab.

Primary Outcome Measure

Percentage of Participants with Adverse Events [ Time Frame: Up to 6 years ]

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