Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

5

Indication details

Control Arm
Everolimus
FDA Therapeutic Indication
As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults
Tumour Type
Genitourinary Cancers
Tumour Sub-type
Renal cell cancer
Tumour Stage
Advanced
Trial Name
CheckMate025
NCT Number
NCT01668784
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval November 2015
EMA Approval
EMA (CHMP) February 2016 EC decision April 2016

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
19.6 months
OS Gain
5.4 months
OS HR
0.73 (0.62-0.85)

Adjustments

QoL Comment
Improved QoL
Toxicity Comment
Reduced grade 3/4 adverse events 19% vs 37%

Score (after adjustments)

Preliminary non-curative score

4

QoL adjustment
+1
Non-curative score

5

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
103
Scorecard version
1
Issue date
11.12.2018
Last update
16.05.2023
Nivolumab CheckMate025

PRELIMINARY SCORE

OS

ADJUSTMENTS

Improved QoL
Less serious and disabling adverse events observed
Nivolumab CheckMate025

SCORE

Overall Survival / Disease-Free Survival / Pathological Complete Response
5
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Genitourinary Cancers
As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults
Nivolumab
Everolimus

My watchlist

    pdf
    pptx

    Legend

    Information about symbols, abbrevations and color codes

    Red = negative
    Green = positive
    Grey = neutral
    ? Grey + ? = neutral with pending data
    DFS
    Disease-Free Survival
    DoR
    Duration of Response
    EFS
    Event-Free Survival
    HR
    Hazard Ratio
    NEB
    No evaluable benefit
    NI
    Non-inferiority Study
    ORR
    Overall Response Rate
    OS
    Overall Surival
    pCR
    Pathological Complete Response/Remission
    PFS
    Progression-Free Survival
    QoL
    Quality of Life
    RFS
    Relapse-Free Survival
    RR
    Response Rate

    QoL adjustments

    Other adjustments*

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    QoL adjustments

    Red = negative / deterioration

    Green = positive / improvement

    Other adjustments*

    Red = negative / deterioration

    Green = positive / improvement

    Serious and disabling adverse effects

    Red = negative / deterioration

    Green = positive / improvement

    * Other adjustments include:

    - Long-term plateau in the survival curve
    - Long-term plateau in the PFS curve
    - Early stopping or crossover
    - Only improved PFS mature data shows no OS advantage and no improved Qol.

    This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

    For more detailed information on the cookies we use, please check our Privacy Policy.

    Customise settings
    • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.