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← JOBEVNE: metastatic Renal cell carcinoma

NCT02853331 · STUDY IN CONTEXT

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-42

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.

The analysis population consisted of all randomized participants.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented.

The analysis population consisted of all randomized participants.

→

secondary · POSTED

ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR or PR is presented.

The analysis population consisted of all randomized participants.

→

secondary · POSTED

DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. The DCR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR, PR, or SD is presented.

The analysis population consisted of all randomized participants who experienced a PR, CR or SD for ≥6 months.

→

secondary · POSTED

DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented.

The analysis population consisted of all randomized participants who experienced a CR or PR.

→

secondary · POSTED

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.

The analysis population consisted of all participants who received ≥1 dose of study treatment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT02853331
qol key
qol-0013
source section id
NCT02853331-om-0013
source outcome index
13
instrument
FACT
instrument basis
matched 'fksi' in the study's own wording
scale title
Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score
measure definition
TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.
time frame
Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicating a better
population note
All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT02853331
qol key
qol-0014
source section id
NCT02853331-om-0014
source outcome index
14
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status.
time frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 54
analysis role
secondary
reporting status
NOT_POSTED
higher is better
1
direction quote
higher score indicating improved
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Mean Baseline EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT02853331
qol key
qol-0015
source section id
NCT02853331-om-0015
source outcome index
15
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Mean Baseline EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The mean baseline EORTC QLQ-C30 score is presented.
time frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days])
analysis role
exploratory
reporting status
POSTED
higher is better
1
direction quote
higher score indicating improved
population note
All participants with non-missing questionnaire assessments at baseline.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT02853331
qol key
qol-0016
source section id
NCT02853331-om-0016
source outcome index
16
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
measure definition
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life on a 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100; with a high score indicating improved health status. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The LS Mean change from baseline to Week 30 is presented.
time frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 30
analysis role
post-hoc
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All participants who received at least 1 dose of study medication and had non-missing questionnaire assessments at baseline and Week 30.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT02853331
trial label
Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-42
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0000
    source section id
    NCT02853331-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.
    time origin
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0001
    source section id
    NCT02853331-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented.
    time origin
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0002
    source section id
    NCT02853331-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
    endpoint definition
    ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR or PR is presented.
    time origin
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0003
    source section id
    NCT02853331-om-0003
    source outcome index
    3
    endpoint
    Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
    endpoint definition
    DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. The DCR was calculated using the Miettinen \& Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR, PR, or SD is presented.
    time origin
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who experienced a PR, CR or SD for ≥6 months.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0004
    source section id
    NCT02853331-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
    endpoint definition
    DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented.
    time origin
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who experienced a CR or PR.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0005
    source section id
    NCT02853331-om-0005
    source outcome index
    5
    endpoint
    Number of Participants Who Experienced an Adverse Event (AE)
    endpoint definition
    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
    time origin
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all participants who received ≥1 dose of study treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pembrolizumab + Axitinib
    regimen
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    analyzed count
    432
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Sunitinib
    regimen
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pembrolizumab + Axitinib
    regimen
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    analyzed count
    432
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Sunitinib
    regimen
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pembrolizumab + Axitinib
    regimen
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    analyzed count
    432
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Sunitinib
    regimen
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pembrolizumab + Axitinib
    regimen
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    analyzed count
    432
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Sunitinib
    regimen
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pembrolizumab + Axitinib
    regimen
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    analyzed count
    256
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Sunitinib
    regimen
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    analyzed count
    153
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pembrolizumab + Axitinib
    regimen
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    analyzed count
    429
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Sunitinib
    regimen
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    analyzed count
    425
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02853331-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    harm key
    EG000
    source section id
    NCT02853331-ae
    event group key
    EG000
    event group label
    Pembrolizumab + Axitinib
    serious affected
    173
    serious at risk
    429
    other affected
    417
    other at risk
    429
    frequency threshold
    5
    collection period
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    event definition
    Population: All participants who received ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    harm key
    EG001
    source section id
    NCT02853331-ae
    event group key
    EG001
    event group label
    Sunitinib
    serious affected
    133
    serious at risk
    425
    other affected
    415
    other at risk
    425
    frequency threshold
    5
    collection period
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    event definition
    Population: All participants who received ≥1 dose of study treatment. Per protocol, progression of cancer under study was not considered an AE unless related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study drug are excluded as AEs.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    qol key
    qol-0013
    source section id
    NCT02853331-om-0013
    source outcome index
    13
    instrument
    FACT
    instrument basis
    matched 'fksi' in the study's own wording
    scale title
    Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score
    measure definition
    TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.
    time frame
    Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicating a better
    population note
    All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    qol key
    qol-0014
    source section id
    NCT02853331-om-0014
    source outcome index
    14
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status.
    time frame
    Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 54
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    1
    direction quote
    higher score indicating improved
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    qol key
    qol-0015
    source section id
    NCT02853331-om-0015
    source outcome index
    15
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Mean Baseline EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The mean baseline EORTC QLQ-C30 score is presented.
    time frame
    Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days])
    analysis role
    exploratory
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicating improved
    population note
    All participants with non-missing questionnaire assessments at baseline.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-jobevne-9feed5d7
    nct id
    NCT02853331
    qol key
    qol-0016
    source section id
    NCT02853331-om-0016
    source outcome index
    16
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
    measure definition
    EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life on a 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100; with a high score indicating improved health status. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The LS Mean change from baseline to Week 30 is presented.
    time frame
    Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 30
    analysis role
    post-hoc
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All participants who received at least 1 dose of study medication and had non-missing questionnaire assessments at baseline and Week 30.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice