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A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma (IMmotion150)

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ClinicalTrials.gov Identifier: NCT01984242
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Results First Posted : December 21, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Interventions: Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Drug: Bevacizumab
Drug: Sunitinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 305 participants were enrolled in this study. Participants enrolled in atezolizumab (except European Union [EU] participants) or sunitinib group could crossover to receive atezolizumab and bevacizumab combination therapy in case of disease progression.

Reporting Groups
  Description
Atezolizumab and Bevacizumab Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.

Participant Flow:   Overall Study
    Atezolizumab and Bevacizumab   Atezolizumab   Sunitinib
STARTED   101   103   101 
Treated   101   103   100 
Crossover Population   0   44   57 
COMPLETED   0   0   0 
NOT COMPLETED   101   103   101 
Death                37                36                30 
Withdrawal by Subject                2                2                5 
Physician Decision                1                0                2 
Lost to Follow-up                0                0                1 
Other                1                0                1 
Randomized, but not treated                0                0                1 
Ongoing in Study                60                65                61 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study drug.

Reporting Groups
  Description
Atezolizumab and Bevacizumab Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) were administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression.
Atezolizumab Atezolizumab 1200 mg was administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except EU participants) could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Sunitinib Sunitinib 50 mg was administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants could crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Total Total of all reporting groups

Baseline Measures
   Atezolizumab and Bevacizumab   Atezolizumab   Sunitinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   103   101   305 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.1  (10.8)   60.1  (10.2)   59.7  (10.8)   60.3  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      27  26.7%      26  25.2%      22  21.8%      75  24.6% 
Male      74  73.3%      77  74.8%      79  78.2%      230  75.4% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

2.  Primary:   Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

3.  Primary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

4.  Primary:   PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

5.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

6.  Secondary:   PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

7.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

8.  Secondary:   PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

9.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

10.  Secondary:   PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

11.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

12.  Secondary:   PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

13.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

14.  Secondary:   PFS Per RECIST v1.1 Via Investigator Assessment in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

15.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

16.  Secondary:   PFS Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

17.  Secondary:   Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) Per RECIST v1.1 Via IRC Assessment in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

18.  Secondary:   Percentage of Participants With Objective Response Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

19.  Secondary:   Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

20.  Secondary:   Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

21.  Secondary:   Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

22.  Secondary:   Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

23.  Secondary:   Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

24.  Secondary:   PFS Per Modified RECIST Via Investigator Assessment in ITT Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

25.  Secondary:   Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

26.  Secondary:   PFS Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population   [ Time Frame: From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

27.  Secondary:   Duration of Response (DOR) Per RECIST v1.1 Via IRC Assessment in ITT Population   [ Time Frame: From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

28.  Secondary:   DOR Per RECIST v1.1 Via Investigator Assessment in ITT Population   [ Time Frame: From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

29.  Secondary:   DOR Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population   [ Time Frame: From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

30.  Secondary:   DOR Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population   [ Time Frame: From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

31.  Secondary:   DOR Per Modified RECIST Via Investigator Assessment in ITT Population   [ Time Frame: From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

32.  Secondary:   DOR Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population   [ Time Frame: From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

33.  Secondary:   Percentage of Participants Who Died in ITT Population   [ Time Frame: Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

34.  Secondary:   Overall Survival (OS) in ITT Population   [ Time Frame: Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

35.  Secondary:   Percentage of Participants Who Died in IC1/2/3 Population   [ Time Frame: Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

36.  Secondary:   OS in IC1/2/3 Population   [ Time Frame: Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

37.  Secondary:   Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in Crossover Population   [ Time Frame: From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

38.  Secondary:   DOR Per RECIST v1.1 Via Investigator Assessment in Crossover Population   [ Time Frame: From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

39.  Secondary:   Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Crossover Population   [ Time Frame: From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

40.  Secondary:   PFS Per RECIST v.1.1 Via Investigator Assessment in Crossover Population   [ Time Frame: From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years) ]

41.  Secondary:   Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab   [ Time Frame: Cycle 1 Day 1 until treatment discontinuation (until data cut-off date 17 October 2016, up to approximately 2.75 years) (1 cycle=6 weeks) ]

42.  Secondary:   Maximum Serum Concentration (Cmax) of Atezolizumab   [ Time Frame: 30 minutes after end of infusion on Cycle 1 Day 1 (1 cycle=6 weeks) (infusion length for first dose=60 minutes) ]

43.  Secondary:   Minimum Serum Concentration (Cmin) of Atezolizumab   [ Time Frame: Pre-infusion (0 hour) on Day 1 of Cycles 2 and 4; Day 22 of Cycles 1, 2, and 4 (1 cycle=6 weeks) (infusion length=30-60 minutes) ]

44.  Secondary:   Cmax of Bevacizumab   [ Time Frame: 30 minutes after end of infusion on Day 1 of Cycles 1 and 2 (1 cycle=6 weeks) (infusion length=30-90 minutes) ]

45.  Secondary:   Cmin of Bevacizumab   [ Time Frame: For Atezolizumab and Bevacizumab Arm: at First-line treatment discontinuation (up to approximately 2.75 years); For Crossover Arms: pre-infusion (0 hour) on Day 1 of Cycle 2 (1 cycle=6 weeks) (infusion length=30-90 minutes) ]

46.  Secondary:   M.D. Anderson Symptom Inventory (MDASI) Interference Score   [ Time Frame: Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks) ]

47.  Secondary:   Brief Fatigue Inventory (BFI) Fatigue Level Score   [ Time Frame: Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks) ]

48.  Other Pre-specified:   EuroQoL 5 Dimension (EQ-5D) Questionnaire Score   [ Time Frame: Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01984242     History of Changes
Other Study ID Numbers: WO29074
2013-003167-58 ( EudraCT Number )
First Submitted: November 7, 2013
First Posted: November 14, 2013
Results First Submitted: October 11, 2017
Results First Posted: December 21, 2017
Last Update Posted: March 14, 2018