Unresectable or Metastatic Melanoma
Conditions
Brief summary
The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
Interventions
BIOLOGICALNivolumab
BIOLOGICALIpilimumab
BIOLOGICALPlacebo for Nivolumab
BIOLOGICALPlacebo for Ipilimumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histologically confirmed stage III (unresectable) or stage IV melanoma * Treatment naïve patients * Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria * Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion criteria
* Active brain metastases or leptomeningeal metastases * Ocular melanoma * Subjects with active, known or suspected autoimmune disease * Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment * Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization to date of death (Assessed up to September 2016, approximately 39 months) | OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. |
| Progression Free Survival (PFS) | From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months) | PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. |
| Rate of Overall Survival | 24 months | OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization. |
| Rate of Progression-Free Survival | 24 months | PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Based on PD-L1 Expression Level | From randomization until death (assessed up to approximately 128 months) | OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157 | Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157 | Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. |
| Overall Survival (OS) | From randomization until death (assessed up to approximately 128 months) | OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157 | Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157 | Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157 | Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157 | Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. |
| Progression Free Survival (PFS) | From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months) | PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. |
| Objective Response Rate (ORR) Per Investigator Assessment | From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months) | The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \>=50% of previously involved sites from nadir. |
| Progression-Free Survival Based on PD-L1 Expression Level | From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months) | PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 \>=5% or PD-L1 \<5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized. |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity | 316 |
| Nivolumab + Ipilimumab Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity | 314 |
| Ipilimumab Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses | 315 |
| Total | 945 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period | Death | 175 | 154 | 228 |
| Treatment Period | Lost to Follow-up | 9 | 11 | 6 |
| Treatment Period | Other Reasons | 120 | 136 | 58 |
| Treatment Period | SUBJECT WITHDREW CONSENT | 9 | 12 | 19 |
Baseline characteristics
| Characteristic | Nivolumab | Nivolumab + Ipilimumab | Ipilimumab | Total |
|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 13.92 | 59.3 years STANDARD_DEVIATION 13.86 | 60.8 years STANDARD_DEVIATION 13.23 | 59.6 years STANDARD_DEVIATION 13.69 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN | 2 Participants | 2 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized NOT REPORTED | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized OTHER | 4 Participants | 2 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized WHITE | 308 Participants | 310 Participants | 303 Participants | 921 Participants |
| Sex: Female, Male Female | 114 Participants | 108 Participants | 113 Participants | 335 Participants |
| Sex: Female, Male Male | 202 Participants | 206 Participants | 202 Participants | 610 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 192 / 316 | 173 / 314 | 243 / 315 |
| other Total, other adverse events | 302 / 313 | 302 / 313 | 302 / 311 |
| serious Total, serious adverse events | 187 / 313 | 249 / 313 | 205 / 311 |
Outcome results
Primary
Overall Survival (OS)
OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time frame: From randomization to date of death (Assessed up to September 2016, approximately 39 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab | Overall Survival (OS) | NA months |
| Nivolumab + Ipilimumab | Overall Survival (OS) | NA months |
| Ipilimumab | Overall Survival (OS) | 19.98 months |
p-value: <0.000198% CI: [0.5, 0.78]Log Rank
p-value: <0.000198% CI: [0.42, 0.72]Log Rank
Primary
Progression Free Survival (PFS)
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Time frame: From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab | Progression Free Survival (PFS) | 6.87 months |
| Nivolumab + Ipilimumab | Progression Free Survival (PFS) | 11.50 months |
| Ipilimumab | Progression Free Survival (PFS) | 2.89 months |
p-value: <0.000199.5% CI: [0.43, 0.76]Stratified Log Rank test
p-value: <0.000199.5% CI: [0.31, 0.57]Stratified Log Rank test
Primary
Rate of Overall Survival
OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.
Time frame: 24 months
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Rate of Overall Survival | Rate of OS at 24 months | 0.59 Probability of survival at Time T |
| Nivolumab | Rate of Overall Survival | Rate of OS at 12 months | 0.74 Probability of survival at Time T |
| Nivolumab | Rate of Overall Survival | Rate of OS at 6 months | 0.85 Probability of survival at Time T |
| Nivolumab + Ipilimumab | Rate of Overall Survival | Rate of OS at 24 months | 0.64 Probability of survival at Time T |
| Nivolumab + Ipilimumab | Rate of Overall Survival | Rate of OS at 6 months | 0.86 Probability of survival at Time T |
| Nivolumab + Ipilimumab | Rate of Overall Survival | Rate of OS at 12 months | 0.73 Probability of survival at Time T |
| Ipilimumab | Rate of Overall Survival | Rate of OS at 12 months | 0.67 Probability of survival at Time T |
| Ipilimumab | Rate of Overall Survival | Rate of OS at 6 months | 0.82 Probability of survival at Time T |
| Ipilimumab | Rate of Overall Survival | Rate of OS at 24 months | 0.45 Probability of survival at Time T |
Primary
Rate of Progression-Free Survival
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Time frame: 24 months
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab | Rate of Progression-Free Survival | Rate at 12 months | 0.43 Percentage of participants |
| Nivolumab | Rate of Progression-Free Survival | Rate at 6 months | 0.52 Percentage of participants |
| Nivolumab | Rate of Progression-Free Survival | Rate at 24 months | 0.37 Percentage of participants |
| Nivolumab + Ipilimumab | Rate of Progression-Free Survival | Rate at 12 months | 0.50 Percentage of participants |
| Nivolumab + Ipilimumab | Rate of Progression-Free Survival | Rate at 6 months | 0.63 Percentage of participants |
| Nivolumab + Ipilimumab | Rate of Progression-Free Survival | Rate at 24 months | 0.43 Percentage of participants |
| Ipilimumab | Rate of Progression-Free Survival | Rate at 6 months | 0.28 Percentage of participants |
| Ipilimumab | Rate of Progression-Free Survival | Rate at 24 months | 0.12 Percentage of participants |
| Ipilimumab | Rate of Progression-Free Survival | Rate at 12 months | 0.18 Percentage of participants |
Secondary
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning
Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Time frame: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157
Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 7 (n= 239, 183, 218) | -1.7 Points on EORTC scale | Standard Deviation 12.8 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 103 (n= 53, 46, 17) | -2.5 Points on EORTC scale | Standard Deviation 15.81 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 43 (n= 103, 74, 44) | -1.6 Points on EORTC scale | Standard Deviation 15.4 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 145 (n= 14, 14, 6) | -11.9 Points on EORTC scale | Standard Deviation 29.55 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 97 (n= 58, 49, 17) | -3.2 Points on EORTC scale | Standard Deviation 14.12 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 49 (n= 97, 70, 40) | -1.2 Points on EORTC scale | Standard Deviation 12.32 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 13 (n= 195, 106, 130) | -0.9 Points on EORTC scale | Standard Deviation 13.45 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 91 (n= 62, 53, 16) | -0.5 Points on EORTC scale | Standard Deviation 12.06 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 55 (n= 86, 66, 34) | 0.4 Points on EORTC scale | Standard Deviation 13.52 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 139 (n= 20, 19, 6) | -3.3 Points on EORTC scale | Standard Deviation 6.84 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 85 (n= 68, 51, 18) | -1.5 Points on EORTC scale | Standard Deviation 12.79 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 61 (n= 85, 61, 31) | 0.0 Points on EORTC scale | Standard Deviation 14.09 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 17 (n= 158, 84, 104) | -0.9 Points on EORTC scale | Standard Deviation 12.79 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 79 (n= 67, 54, 21) | -0.2 Points on EORTC scale | Standard Deviation 12.48 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 67 (n= 76, 61, 29) | -1.3 Points on EORTC scale | Standard Deviation 13.27 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 157 (n= 1, 3, 0) | 0.0 Points on EORTC scale | — |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 73 (n= 67, 54, 19) | -2.2 Points on EORTC scale | Standard Deviation 11.2 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 133 (n= 29, 31, 11) | -4.6 Points on EORTC scale | Standard Deviation 22.67 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 19 (n= 164, 96, 98) | -1.9 Points on EORTC scale | Standard Deviation 13.99 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 5 (n= 233, 183, 221) | 0.1 Points on EORTC scale | Standard Deviation 12.28 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 127 (n= 47, 36, 17) | -2.8 Points on EORTC scale | Standard Deviation 17.83 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 23 (n= 134, 86, 75) | -0.6 Points on EORTC scale | Standard Deviation 13.31 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 121 (n= 44, 39, 16) | -1.1 Points on EORTC scale | Standard Deviation 14.56 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 25 (n= 144, 97, 75) | -1.2 Points on EORTC scale | Standard Deviation 12.72 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 151 (n= 7, 7, 1) | -2.4 Points on EORTC scale | Standard Deviation 11.5 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 115 (n= 44, 36, 17) | 0.4 Points on EORTC scale | Standard Deviation 9.84 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 31 (n= 123, 92, 51) | 1.1 Points on EORTC scale | Standard Deviation 12.4 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 11 (n= 201, 112, 163) | -1.7 Points on EORTC scale | Standard Deviation 13.27 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 109 (n= 44, 39, 14) | 1.1 Points on EORTC scale | Standard Deviation 10.42 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 37 (n= 116, 88, 48) | 1.6 Points on EORTC scale | Standard Deviation 11.42 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 157 (n= 1, 3, 0) | -11.1 Points on EORTC scale | Standard Deviation 9.62 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 13 (n= 195, 106, 130) | -0.3 Points on EORTC scale | Standard Deviation 14.36 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 23 (n= 134, 86, 75) | -4.5 Points on EORTC scale | Standard Deviation 21.61 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 139 (n= 20, 19, 6) | -6.1 Points on EORTC scale | Standard Deviation 11.4 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 5 (n= 233, 183, 221) | -2.1 Points on EORTC scale | Standard Deviation 16.49 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 7 (n= 239, 183, 218) | -3.6 Points on EORTC scale | Standard Deviation 16.26 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 11 (n= 201, 112, 163) | -0.1 Points on EORTC scale | Standard Deviation 16.67 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 17 (n= 158, 84, 104) | -3.6 Points on EORTC scale | Standard Deviation 19.37 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 19 (n= 164, 96, 98) | -1.0 Points on EORTC scale | Standard Deviation 17.07 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 25 (n= 144, 97, 75) | -4.8 Points on EORTC scale | Standard Deviation 20.26 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 31 (n= 123, 92, 51) | -1.6 Points on EORTC scale | Standard Deviation 17.13 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 37 (n= 116, 88, 48) | -2.8 Points on EORTC scale | Standard Deviation 17.91 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 43 (n= 103, 74, 44) | -2.9 Points on EORTC scale | Standard Deviation 13.89 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 49 (n= 97, 70, 40) | -1.2 Points on EORTC scale | Standard Deviation 15.1 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 55 (n= 86, 66, 34) | -2.8 Points on EORTC scale | Standard Deviation 14.79 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 61 (n= 85, 61, 31) | -1.6 Points on EORTC scale | Standard Deviation 15.12 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 67 (n= 76, 61, 29) | -3.0 Points on EORTC scale | Standard Deviation 17.35 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 73 (n= 67, 54, 19) | -4.9 Points on EORTC scale | Standard Deviation 19.86 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 79 (n= 67, 54, 21) | -4.6 Points on EORTC scale | Standard Deviation 20.58 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 85 (n= 68, 51, 18) | -4.2 Points on EORTC scale | Standard Deviation 17.9 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 91 (n= 62, 53, 16) | -4.7 Points on EORTC scale | Standard Deviation 19.44 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 97 (n= 58, 49, 17) | -3.7 Points on EORTC scale | Standard Deviation 13.72 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 103 (n= 53, 46, 17) | -5.8 Points on EORTC scale | Standard Deviation 23.63 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 109 (n= 44, 39, 14) | -3.8 Points on EORTC scale | Standard Deviation 19.29 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 115 (n= 44, 36, 17) | -3.7 Points on EORTC scale | Standard Deviation 15.49 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 121 (n= 44, 39, 16) | -7.7 Points on EORTC scale | Standard Deviation 15.22 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 127 (n= 47, 36, 17) | -3.2 Points on EORTC scale | Standard Deviation 13.1 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 133 (n= 29, 31, 11) | -3.8 Points on EORTC scale | Standard Deviation 13.41 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 145 (n= 14, 14, 6) | -4.8 Points on EORTC scale | Standard Deviation 12.1 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 151 (n= 7, 7, 1) | -7.1 Points on EORTC scale | Standard Deviation 13.11 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 139 (n= 20, 19, 6) | 5.6 Points on EORTC scale | Standard Deviation 8.61 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 97 (n= 58, 49, 17) | -2.0 Points on EORTC scale | Standard Deviation 10 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 37 (n= 116, 88, 48) | -5.6 Points on EORTC scale | Standard Deviation 15.88 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 11 (n= 201, 112, 163) | -4.7 Points on EORTC scale | Standard Deviation 15.33 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 103 (n= 53, 46, 17) | -5.9 Points on EORTC scale | Standard Deviation 15.52 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 31 (n= 123, 92, 51) | -3.3 Points on EORTC scale | Standard Deviation 12.48 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 5 (n= 233, 183, 221) | -0.2 Points on EORTC scale | Standard Deviation 13.99 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 25 (n= 144, 97, 75) | -2.4 Points on EORTC scale | Standard Deviation 12.46 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 145 (n= 14, 14, 6) | -5.6 Points on EORTC scale | Standard Deviation 17.21 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 115 (n= 44, 36, 17) | -2.0 Points on EORTC scale | Standard Deviation 10 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 23 (n= 134, 86, 75) | -5.6 Points on EORTC scale | Standard Deviation 14.58 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 7 (n= 239, 183, 218) | -1.5 Points on EORTC scale | Standard Deviation 13.36 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 121 (n= 44, 39, 16) | -1.0 Points on EORTC scale | Standard Deviation 9.56 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 19 (n= 164, 96, 98) | -2.2 Points on EORTC scale | Standard Deviation 13.39 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 109 (n= 44, 39, 14) | -1.2 Points on EORTC scale | Standard Deviation 7.91 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 127 (n= 47, 36, 17) | -1.0 Points on EORTC scale | Standard Deviation 13.78 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 67 (n= 76, 61, 29) | -7.5 Points on EORTC scale | Standard Deviation 16.42 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 17 (n= 158, 84, 104) | -2.4 Points on EORTC scale | Standard Deviation 13.43 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 73 (n= 67, 54, 19) | -6.1 Points on EORTC scale | Standard Deviation 11.4 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 61 (n= 85, 61, 31) | -3.2 Points on EORTC scale | Standard Deviation 15.76 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 151 (n= 7, 7, 1) | 16.7 Points on EORTC scale | — |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 79 (n= 67, 54, 21) | -4.8 Points on EORTC scale | Standard Deviation 13.06 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 55 (n= 86, 66, 34) | -2.5 Points on EORTC scale | Standard Deviation 12.4 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 133 (n= 29, 31, 11) | 1.5 Points on EORTC scale | Standard Deviation 8.99 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 85 (n= 68, 51, 18) | -2.8 Points on EORTC scale | Standard Deviation 13.1 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 49 (n= 97, 70, 40) | 0.4 Points on EORTC scale | Standard Deviation 12.22 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 13 (n= 195, 106, 130) | -2.3 Points on EORTC scale | Standard Deviation 14.64 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 91 (n= 62, 53, 16) | -1.0 Points on EORTC scale | Standard Deviation 9.56 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning | Week 43 (n= 103, 74, 44) | 0.0 Points on EORTC scale | Standard Deviation 11.37 |
Secondary
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning
Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Time frame: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157
Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 37 (n= 116, 88, 48) | 9.6 Points on EORTC scale | Standard Deviation 15.6 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 7 (n= 239, 183, 218) | 4.0 Points on EORTC scale | Standard Deviation 16.82 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 91 (n= 62, 53, 16) | 9.1 Points on EORTC scale | Standard Deviation 17.77 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 43 (n= 103, 74, 44) | 6.7 Points on EORTC scale | Standard Deviation 18.89 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 11 (n= 201, 112, 163) | 5.3 Points on EORTC scale | Standard Deviation 14.84 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 85 (n= 68, 51, 18) | 6.4 Points on EORTC scale | Standard Deviation 16.55 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 49 (n= 97, 70, 40) | 5.8 Points on EORTC scale | Standard Deviation 18.61 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 139 (n= 20, 19, 6) | 9.6 Points on EORTC scale | Standard Deviation 11.87 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 79 (n= 67, 54, 21) | 7.6 Points on EORTC scale | Standard Deviation 19.56 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 55 (n= 86, 66, 34) | 8.1 Points on EORTC scale | Standard Deviation 18.57 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 109 (n= 44, 39, 14) | 8.3 Points on EORTC scale | Standard Deviation 17.33 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 73 (n= 67, 54, 19) | 8.0 Points on EORTC scale | Standard Deviation 18.66 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 61 (n= 85, 61, 31) | 7.9 Points on EORTC scale | Standard Deviation 18.54 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 133 (n= 29, 31, 11) | 7.5 Points on EORTC scale | Standard Deviation 19.46 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 67 (n= 76, 61, 29) | 7.8 Points on EORTC scale | Standard Deviation 19.97 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 13 (n= 195, 106, 130) | 3.8 Points on EORTC scale | Standard Deviation 15.99 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 115 (n= 44, 36, 17) | 8.1 Points on EORTC scale | Standard Deviation 21.15 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 17 (n= 158, 84, 104) | 5.6 Points on EORTC scale | Standard Deviation 16.54 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 151 (n= 7, 7, 1) | 17.9 Points on EORTC scale | Standard Deviation 16.27 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 19 (n= 164, 96, 98) | 5.8 Points on EORTC scale | Standard Deviation 16.26 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 5 (n= 233, 183, 221) | 4.6 Points on EORTC scale | Standard Deviation 15.91 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 127 (n= 47, 36, 17) | 10.6 Points on EORTC scale | Standard Deviation 17.61 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 23 (n= 134, 86, 75) | 6.1 Points on EORTC scale | Standard Deviation 17.04 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 157 (n= 1, 3, 0) | 16.7 Points on EORTC scale | — |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 121 (n= 44, 39, 16) | 8.3 Points on EORTC scale | Standard Deviation 20.01 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 25 (n= 144, 97, 75) | 6.6 Points on EORTC scale | Standard Deviation 16.31 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 103 (n= 53, 46, 17) | 6.6 Points on EORTC scale | Standard Deviation 19.5 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 31 (n= 123, 92, 51) | 8.3 Points on EORTC scale | Standard Deviation 15.57 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 145 (n= 14, 14, 6) | 2.4 Points on EORTC scale | Standard Deviation 18.32 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 97 (n= 58, 49, 17) | 5.3 Points on EORTC scale | Standard Deviation 17.78 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 157 (n= 1, 3, 0) | -11.1 Points on EORTC scale | Standard Deviation 17.35 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 25 (n= 144, 97, 75) | 2.1 Points on EORTC scale | Standard Deviation 19.69 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 5 (n= 233, 183, 221) | 2.5 Points on EORTC scale | Standard Deviation 16.44 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 7 (n= 239, 183, 218) | 2.0 Points on EORTC scale | Standard Deviation 18.1 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 11 (n= 201, 112, 163) | 3.7 Points on EORTC scale | Standard Deviation 15.57 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 13 (n= 195, 106, 130) | 4.3 Points on EORTC scale | Standard Deviation 17.53 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 17 (n= 158, 84, 104) | 4.2 Points on EORTC scale | Standard Deviation 18.81 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 19 (n= 164, 96, 98) | 6.2 Points on EORTC scale | Standard Deviation 19.01 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 23 (n= 134, 86, 75) | 4.5 Points on EORTC scale | Standard Deviation 20.2 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 31 (n= 123, 92, 51) | 4.7 Points on EORTC scale | Standard Deviation 15.64 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 37 (n= 116, 88, 48) | 6.8 Points on EORTC scale | Standard Deviation 17.98 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 43 (n= 103, 74, 44) | 7.5 Points on EORTC scale | Standard Deviation 18.36 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 49 (n= 97, 70, 40) | 7.1 Points on EORTC scale | Standard Deviation 19.67 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 55 (n= 86, 66, 34) | 8.3 Points on EORTC scale | Standard Deviation 16.79 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 61 (n= 85, 61, 31) | 7.9 Points on EORTC scale | Standard Deviation 22.69 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 67 (n= 76, 61, 29) | 7.1 Points on EORTC scale | Standard Deviation 20.52 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 73 (n= 67, 54, 19) | 4.5 Points on EORTC scale | Standard Deviation 18.29 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 79 (n= 67, 54, 21) | 2.9 Points on EORTC scale | Standard Deviation 23.36 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 85 (n= 68, 51, 18) | 3.3 Points on EORTC scale | Standard Deviation 21.09 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 91 (n= 62, 53, 16) | 4.7 Points on EORTC scale | Standard Deviation 20.25 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 97 (n= 58, 49, 17) | 3.9 Points on EORTC scale | Standard Deviation 21.05 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 103 (n= 53, 46, 17) | 1.4 Points on EORTC scale | Standard Deviation 23.46 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 109 (n= 44, 39, 14) | 4.1 Points on EORTC scale | Standard Deviation 22.61 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 115 (n= 44, 36, 17) | 6.0 Points on EORTC scale | Standard Deviation 21.23 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 121 (n= 44, 39, 16) | 4.5 Points on EORTC scale | Standard Deviation 21.36 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 127 (n= 47, 36, 17) | 7.2 Points on EORTC scale | Standard Deviation 21.19 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 133 (n= 29, 31, 11) | 8.3 Points on EORTC scale | Standard Deviation 19.48 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 139 (n= 20, 19, 6) | 9.2 Points on EORTC scale | Standard Deviation 16.87 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 145 (n= 14, 14, 6) | 6.0 Points on EORTC scale | Standard Deviation 15.82 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 151 (n= 7, 7, 1) | -2.4 Points on EORTC scale | Standard Deviation 22.93 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 31 (n= 123, 92, 51) | 9.2 Points on EORTC scale | Standard Deviation 16.69 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 7 (n= 239, 183, 218) | 3.1 Points on EORTC scale | Standard Deviation 17.39 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 97 (n= 58, 49, 17) | 3.9 Points on EORTC scale | Standard Deviation 14.47 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 25 (n= 144, 97, 75) | 5.9 Points on EORTC scale | Standard Deviation 17.15 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 13 (n= 195, 106, 130) | 2.9 Points on EORTC scale | Standard Deviation 18.03 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 103 (n= 53, 46, 17) | 4.4 Points on EORTC scale | Standard Deviation 12.88 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 139 (n= 20, 19, 6) | 11.1 Points on EORTC scale | Standard Deviation 10.09 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 109 (n= 44, 39, 14) | 12.5 Points on EORTC scale | Standard Deviation 11.2 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 5 (n= 233, 183, 221) | 3.7 Points on EORTC scale | Standard Deviation 17.21 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 115 (n= 44, 36, 17) | 10.3 Points on EORTC scale | Standard Deviation 10.84 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 23 (n= 134, 86, 75) | 3.7 Points on EORTC scale | Standard Deviation 18.85 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 17 (n= 158, 84, 104) | 4.9 Points on EORTC scale | Standard Deviation 15.86 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 121 (n= 44, 39, 16) | 9.4 Points on EORTC scale | Standard Deviation 7.98 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 19 (n= 164, 96, 98) | 6.5 Points on EORTC scale | Standard Deviation 18.27 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 61 (n= 85, 61, 31) | 9.9 Points on EORTC scale | Standard Deviation 14.82 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 145 (n= 14, 14, 6) | 11.1 Points on EORTC scale | Standard Deviation 10.09 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 67 (n= 76, 61, 29) | 3.7 Points on EORTC scale | Standard Deviation 15.36 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 55 (n= 86, 66, 34) | 12.3 Points on EORTC scale | Standard Deviation 15.11 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 127 (n= 47, 36, 17) | 8.3 Points on EORTC scale | Standard Deviation 13.5 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 73 (n= 67, 54, 19) | 4.8 Points on EORTC scale | Standard Deviation 10.51 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 49 (n= 97, 70, 40) | 8.1 Points on EORTC scale | Standard Deviation 15.5 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 11 (n= 201, 112, 163) | 2.0 Points on EORTC scale | Standard Deviation 18.89 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 79 (n= 67, 54, 21) | 6.7 Points on EORTC scale | Standard Deviation 10.41 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 43 (n= 103, 74, 44) | 6.1 Points on EORTC scale | Standard Deviation 14.86 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 151 (n= 7, 7, 1) | 16.7 Points on EORTC scale | — |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 85 (n= 68, 51, 18) | 7.9 Points on EORTC scale | Standard Deviation 12.61 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 37 (n= 116, 88, 48) | 5.9 Points on EORTC scale | Standard Deviation 16.75 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 133 (n= 29, 31, 11) | 9.1 Points on EORTC scale | Standard Deviation 7.87 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning | Week 91 (n= 62, 53, 16) | 3.6 Points on EORTC scale | Standard Deviation 12.53 |
Secondary
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status
Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Time frame: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157
Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 103 (n= 53, 46, 17) | 2.2 Points on EORTC scale | Standard Deviation 17.61 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 37 (n= 116, 88, 48) | 3.2 Points on EORTC scale | Standard Deviation 18.44 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 11 (n= 201, 112, 163) | -2.0 Points on EORTC scale | Standard Deviation 18.1 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 43 (n= 103, 74, 44) | 3.5 Points on EORTC scale | Standard Deviation 18.28 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 97 (n= 58, 49, 17) | 0.9 Points on EORTC scale | Standard Deviation 17.01 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 91 (n= 62, 53, 16) | 0.9 Points on EORTC scale | Standard Deviation 17.08 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 49 (n= 97, 70, 40) | 2.7 Points on EORTC scale | Standard Deviation 16.52 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 139 (n= 20, 19, 6) | 0.0 Points on EORTC scale | Standard Deviation 18.73 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 79 (n= 67, 54, 21) | -0.1 Points on EORTC scale | Standard Deviation 14.4 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 55 (n= 86, 66, 34) | 1.8 Points on EORTC scale | Standard Deviation 14.26 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 13 (n= 195, 106, 130) | -1.9 Points on EORTC scale | Standard Deviation 16.44 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 61 (n= 85, 61, 31) | 1.6 Points on EORTC scale | Standard Deviation 16.29 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 5 (n= 233, 183, 221) | -2.8 Points on EORTC scale | Standard Deviation 15.74 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 73 (n= 67, 54, 19) | 0.1 Points on EORTC scale | Standard Deviation 19.11 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 67 (n= 76, 61, 29) | 2.1 Points on EORTC scale | Standard Deviation 17.49 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 133 (n= 29, 31, 11) | 3.2 Points on EORTC scale | Standard Deviation 20.7 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 17 (n= 158, 84, 104) | -1.6 Points on EORTC scale | Standard Deviation 19.73 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 157 (n= 1, 3, 0) | 0.0 Points on EORTC scale | — |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 127 (n= 47, 36, 17) | 0.9 Points on EORTC scale | Standard Deviation 20.06 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 19 (n= 164, 96, 98) | -0.8 Points on EORTC scale | Standard Deviation 18.3 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 151 (n= 7, 7, 1) | 3.6 Points on EORTC scale | Standard Deviation 9.45 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 121 (n= 44, 39, 16) | 1.1 Points on EORTC scale | Standard Deviation 19.9 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 23 (n= 134, 86, 75) | -2.8 Points on EORTC scale | Standard Deviation 19.44 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 7 (n= 239, 183, 218) | -2.6 Points on EORTC scale | Standard Deviation 16.89 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 115 (n= 44, 36, 17) | 0.6 Points on EORTC scale | Standard Deviation 15.5 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 25 (n= 144, 97, 75) | 1.3 Points on EORTC scale | Standard Deviation 17.39 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 85 (n= 68, 51, 18) | 2.8 Points on EORTC scale | Standard Deviation 16.64 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 109 (n= 44, 39, 14) | 2.8 Points on EORTC scale | Standard Deviation 16.56 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 31 (n= 123, 92, 51) | 2.5 Points on EORTC scale | Standard Deviation 17.4 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 145 (n= 14, 14, 6) | 0.6 Points on EORTC scale | Standard Deviation 25.42 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 157 (n= 1, 3, 0) | -16.7 Points on EORTC scale | Standard Deviation 8.33 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 5 (n= 233, 183, 221) | -4.3 Points on EORTC scale | Standard Deviation 21.38 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 7 (n= 239, 183, 218) | -5.0 Points on EORTC scale | Standard Deviation 20.6 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 11 (n= 201, 112, 163) | -2.4 Points on EORTC scale | Standard Deviation 21.99 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 13 (n= 195, 106, 130) | -3.8 Points on EORTC scale | Standard Deviation 21.21 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 17 (n= 158, 84, 104) | -6.0 Points on EORTC scale | Standard Deviation 22.01 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 19 (n= 164, 96, 98) | -0.8 Points on EORTC scale | Standard Deviation 21.7 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 23 (n= 134, 86, 75) | -2.6 Points on EORTC scale | Standard Deviation 22 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 25 (n= 144, 97, 75) | -3.3 Points on EORTC scale | Standard Deviation 17.7 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 31 (n= 123, 92, 51) | 1.5 Points on EORTC scale | Standard Deviation 21.47 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 37 (n= 116, 88, 48) | -0.2 Points on EORTC scale | Standard Deviation 21.18 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 43 (n= 103, 74, 44) | -0.5 Points on EORTC scale | Standard Deviation 23.04 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 49 (n= 97, 70, 40) | 0.6 Points on EORTC scale | Standard Deviation 21.95 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 55 (n= 86, 66, 34) | -2.4 Points on EORTC scale | Standard Deviation 22.01 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 61 (n= 85, 61, 31) | -3.6 Points on EORTC scale | Standard Deviation 20.78 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 67 (n= 76, 61, 29) | -2.9 Points on EORTC scale | Standard Deviation 21.35 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 73 (n= 67, 54, 19) | -4.5 Points on EORTC scale | Standard Deviation 21.76 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 79 (n= 67, 54, 21) | -4.8 Points on EORTC scale | Standard Deviation 20.51 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 85 (n= 68, 51, 18) | -3.3 Points on EORTC scale | Standard Deviation 22.37 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 91 (n= 62, 53, 16) | -3.9 Points on EORTC scale | Standard Deviation 20.78 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 97 (n= 58, 49, 17) | -5.1 Points on EORTC scale | Standard Deviation 23.06 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 103 (n= 53, 46, 17) | -9.8 Points on EORTC scale | Standard Deviation 19.03 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 109 (n= 44, 39, 14) | -3.8 Points on EORTC scale | Standard Deviation 23.17 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 115 (n= 44, 36, 17) | -6.9 Points on EORTC scale | Standard Deviation 22.76 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 121 (n= 44, 39, 16) | -1.5 Points on EORTC scale | Standard Deviation 19.2 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 127 (n= 47, 36, 17) | -1.9 Points on EORTC scale | Standard Deviation 22.37 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 133 (n= 29, 31, 11) | -2.4 Points on EORTC scale | Standard Deviation 25.11 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 139 (n= 20, 19, 6) | -4.4 Points on EORTC scale | Standard Deviation 17.43 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 145 (n= 14, 14, 6) | -8.9 Points on EORTC scale | Standard Deviation 8.93 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 151 (n= 7, 7, 1) | -13.1 Points on EORTC scale | Standard Deviation 9.45 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 31 (n= 123, 92, 51) | 2.0 Points on EORTC scale | Standard Deviation 15.51 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 139 (n= 20, 19, 6) | 5.6 Points on EORTC scale | Standard Deviation 15.52 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 103 (n= 53, 46, 17) | 0.0 Points on EORTC scale | Standard Deviation 13.5 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 25 (n= 144, 97, 75) | -4.2 Points on EORTC scale | Standard Deviation 16.52 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 7 (n= 239, 183, 218) | -4.3 Points on EORTC scale | Standard Deviation 18.07 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 109 (n= 44, 39, 14) | -2.4 Points on EORTC scale | Standard Deviation 14.03 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 23 (n= 134, 86, 75) | -3.7 Points on EORTC scale | Standard Deviation 16.28 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 55 (n= 86, 66, 34) | 0.7 Points on EORTC scale | Standard Deviation 13.03 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 115 (n= 44, 36, 17) | -0.5 Points on EORTC scale | Standard Deviation 11.59 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 19 (n= 164, 96, 98) | -5.4 Points on EORTC scale | Standard Deviation 19.52 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 145 (n= 14, 14, 6) | -4.2 Points on EORTC scale | Standard Deviation 17.28 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 121 (n= 44, 39, 16) | -3.1 Points on EORTC scale | Standard Deviation 15.18 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 17 (n= 158, 84, 104) | -6.1 Points on EORTC scale | Standard Deviation 16.8 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 5 (n= 233, 183, 221) | -3.1 Points on EORTC scale | Standard Deviation 17.24 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 127 (n= 47, 36, 17) | 1.5 Points on EORTC scale | Standard Deviation 12.92 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 67 (n= 76, 61, 29) | -6.6 Points on EORTC scale | Standard Deviation 15.17 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 61 (n= 85, 61, 31) | 0.8 Points on EORTC scale | Standard Deviation 11.25 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 13 (n= 195, 106, 130) | -5.5 Points on EORTC scale | Standard Deviation 20.27 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 73 (n= 67, 54, 19) | -3.5 Points on EORTC scale | Standard Deviation 16.97 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 49 (n= 97, 70, 40) | -0.4 Points on EORTC scale | Standard Deviation 15.78 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 37 (n= 116, 88, 48) | -1.9 Points on EORTC scale | Standard Deviation 15.11 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 79 (n= 67, 54, 21) | -0.8 Points on EORTC scale | Standard Deviation 14.65 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 133 (n= 29, 31, 11) | 3.8 Points on EORTC scale | Standard Deviation 13.1 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 85 (n= 68, 51, 18) | 0.0 Points on EORTC scale | Standard Deviation 10.69 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 43 (n= 103, 74, 44) | -0.9 Points on EORTC scale | Standard Deviation 15.59 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 11 (n= 201, 112, 163) | -6.2 Points on EORTC scale | Standard Deviation 18.73 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 91 (n= 62, 53, 16) | 0.5 Points on EORTC scale | Standard Deviation 12.72 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 151 (n= 7, 7, 1) | 8.3 Points on EORTC scale | — |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status | Week 97 (n= 58, 49, 17) | -2.9 Points on EORTC scale | Standard Deviation 12.13 |
Secondary
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning
Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Time frame: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157
Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 109 (n= 44, 39, 14) | 1.7 Points on EORTC scale | Standard Deviation 14.74 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 13 (n= 195, 106, 130) | -1.7 Points on EORTC scale | Standard Deviation 15.79 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 133 (n= 29, 31, 11) | 0.2 Points on EORTC scale | Standard Deviation 23.33 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 5 (n= 233, 183, 221) | -2.6 Points on EORTC scale | Standard Deviation 13.62 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 7 (n= 239, 183, 218) | -2.4 Points on EORTC scale | Standard Deviation 14.53 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 11 (n= 201, 112, 163) | -2.4 Points on EORTC scale | Standard Deviation 16.14 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 17 (n= 158, 84, 104) | -1.4 Points on EORTC scale | Standard Deviation 15.82 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 19 (n= 164, 96, 98) | 0.4 Points on EORTC scale | Standard Deviation 14.14 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 23 (n= 134, 86, 75) | 0.9 Points on EORTC scale | Standard Deviation 13.87 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 25 (n= 144, 97, 75) | 1.4 Points on EORTC scale | Standard Deviation 11.02 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 31 (n= 123, 92, 51) | 1.9 Points on EORTC scale | Standard Deviation 11.6 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 37 (n= 116, 88, 48) | 2.1 Points on EORTC scale | Standard Deviation 13.57 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 43 (n= 103, 74, 44) | 1.9 Points on EORTC scale | Standard Deviation 13.16 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 49 (n= 97, 70, 40) | 1.3 Points on EORTC scale | Standard Deviation 12.08 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 55 (n= 86, 66, 34) | 1.8 Points on EORTC scale | Standard Deviation 11.68 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 61 (n= 85, 61, 31) | 0.2 Points on EORTC scale | Standard Deviation 11.65 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 67 (n= 76, 61, 29) | 0.9 Points on EORTC scale | Standard Deviation 12.44 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 73 (n= 67, 54, 19) | 0.5 Points on EORTC scale | Standard Deviation 14.38 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 79 (n= 67, 54, 21) | -1.7 Points on EORTC scale | Standard Deviation 7.99 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 85 (n= 68, 51, 18) | -1.6 Points on EORTC scale | Standard Deviation 12.86 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 91 (n= 62, 53, 16) | -0.4 Points on EORTC scale | Standard Deviation 13.27 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 97 (n= 58, 49, 17) | -0.4 Points on EORTC scale | Standard Deviation 13.79 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 103 (n= 53, 46, 17) | -1.5 Points on EORTC scale | Standard Deviation 17.18 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 115 (n= 44, 36, 17) | 0.2 Points on EORTC scale | Standard Deviation 14.2 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 121 (n= 44, 39, 16) | -0.3 Points on EORTC scale | Standard Deviation 15.77 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 127 (n= 47, 36, 17) | 1.2 Points on EORTC scale | Standard Deviation 17.21 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 139 (n= 20, 19, 6) | 0.4 Points on EORTC scale | Standard Deviation 7.94 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 145 (n= 14, 14, 6) | -1.4 Points on EORTC scale | Standard Deviation 27.94 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 151 (n= 7, 7, 1) | 8.6 Points on EORTC scale | Standard Deviation 17.52 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 157 (n= 1, 3, 0) | 0.0 Points on EORTC scale | — |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 139 (n= 20, 19, 6) | -3.9 Points on EORTC scale | Standard Deviation 11.4 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 127 (n= 47, 36, 17) | -3.0 Points on EORTC scale | Standard Deviation 16.75 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 85 (n= 68, 51, 18) | -3.5 Points on EORTC scale | Standard Deviation 12.88 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 67 (n= 76, 61, 29) | -1.7 Points on EORTC scale | Standard Deviation 13.22 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 97 (n= 58, 49, 17) | -4.4 Points on EORTC scale | Standard Deviation 16.53 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 157 (n= 1, 3, 0) | -17.8 Points on EORTC scale | Standard Deviation 25.24 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 31 (n= 123, 92, 51) | -2.4 Points on EORTC scale | Standard Deviation 12.91 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 145 (n= 14, 14, 6) | -6.7 Points on EORTC scale | Standard Deviation 9.06 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 49 (n= 97, 70, 40) | -0.1 Points on EORTC scale | Standard Deviation 12.97 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 7 (n= 239, 183, 218) | -5.3 Points on EORTC scale | Standard Deviation 14.92 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 73 (n= 67, 54, 19) | -3.5 Points on EORTC scale | Standard Deviation 11.27 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 103 (n= 53, 46, 17) | -5.4 Points on EORTC scale | Standard Deviation 15.63 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 11 (n= 201, 112, 163) | -5.6 Points on EORTC scale | Standard Deviation 13.76 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 37 (n= 116, 88, 48) | -0.8 Points on EORTC scale | Standard Deviation 13 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 13 (n= 195, 106, 130) | -4.3 Points on EORTC scale | Standard Deviation 14.11 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 133 (n= 29, 31, 11) | 0.4 Points on EORTC scale | Standard Deviation 14.4 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 79 (n= 67, 54, 21) | -4.3 Points on EORTC scale | Standard Deviation 17.09 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 17 (n= 158, 84, 104) | -6.7 Points on EORTC scale | Standard Deviation 17.27 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 121 (n= 44, 39, 16) | -3.4 Points on EORTC scale | Standard Deviation 13.58 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 5 (n= 233, 183, 221) | -4.9 Points on EORTC scale | Standard Deviation 14.52 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 19 (n= 164, 96, 98) | -3.7 Points on EORTC scale | Standard Deviation 14.34 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 55 (n= 86, 66, 34) | -2.9 Points on EORTC scale | Standard Deviation 13.24 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 109 (n= 44, 39, 14) | -1.2 Points on EORTC scale | Standard Deviation 13.92 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 23 (n= 134, 86, 75) | -4.0 Points on EORTC scale | Standard Deviation 15.59 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 43 (n= 103, 74, 44) | -0.5 Points on EORTC scale | Standard Deviation 13.55 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 115 (n= 44, 36, 17) | -2.0 Points on EORTC scale | Standard Deviation 15.1 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 25 (n= 144, 97, 75) | -4.2 Points on EORTC scale | Standard Deviation 14.28 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 91 (n= 62, 53, 16) | -4.2 Points on EORTC scale | Standard Deviation 14.45 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 151 (n= 7, 7, 1) | -9.5 Points on EORTC scale | Standard Deviation 12.68 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 61 (n= 85, 61, 31) | -2.1 Points on EORTC scale | Standard Deviation 13.91 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 97 (n= 58, 49, 17) | -0.8 Points on EORTC scale | Standard Deviation 4 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 31 (n= 123, 92, 51) | -2.9 Points on EORTC scale | Standard Deviation 14.62 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 37 (n= 116, 88, 48) | -2.2 Points on EORTC scale | Standard Deviation 13.71 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 115 (n= 44, 36, 17) | -0.8 Points on EORTC scale | Standard Deviation 3.23 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 43 (n= 103, 74, 44) | -1.7 Points on EORTC scale | Standard Deviation 12.71 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 49 (n= 97, 70, 40) | 0.2 Points on EORTC scale | Standard Deviation 12.31 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 55 (n= 86, 66, 34) | 0.2 Points on EORTC scale | Standard Deviation 10.57 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 145 (n= 14, 14, 6) | -6.7 Points on EORTC scale | Standard Deviation 8.43 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 67 (n= 76, 61, 29) | -3.9 Points on EORTC scale | Standard Deviation 10.62 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 127 (n= 47, 36, 17) | -2.4 Points on EORTC scale | Standard Deviation 5.75 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 73 (n= 67, 54, 19) | -3.9 Points on EORTC scale | Standard Deviation 7.8 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 79 (n= 67, 54, 21) | -1.3 Points on EORTC scale | Standard Deviation 6.54 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 133 (n= 29, 31, 11) | -2.4 Points on EORTC scale | Standard Deviation 6.16 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 85 (n= 68, 51, 18) | -2.6 Points on EORTC scale | Standard Deviation 6.11 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 151 (n= 7, 7, 1) | 0.0 Points on EORTC scale | — |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 91 (n= 62, 53, 16) | 0.0 Points on EORTC scale | Standard Deviation 0 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 61 (n= 85, 61, 31) | -0.2 Points on EORTC scale | Standard Deviation 11.35 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 121 (n= 44, 39, 16) | -2.5 Points on EORTC scale | Standard Deviation 5.37 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 5 (n= 233, 183, 221) | -5.2 Points on EORTC scale | Standard Deviation 14.09 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 139 (n= 20, 19, 6) | -3.3 Points on EORTC scale | Standard Deviation 5.58 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 7 (n= 239, 183, 218) | -5.1 Points on EORTC scale | Standard Deviation 14.69 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 11 (n= 201, 112, 163) | -6.3 Points on EORTC scale | Standard Deviation 14.72 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 13 (n= 195, 106, 130) | -5.0 Points on EORTC scale | Standard Deviation 17.47 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 103 (n= 53, 46, 17) | -2.4 Points on EORTC scale | Standard Deviation 7.05 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 17 (n= 158, 84, 104) | -3.7 Points on EORTC scale | Standard Deviation 13.46 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 19 (n= 164, 96, 98) | -4.3 Points on EORTC scale | Standard Deviation 17.7 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 23 (n= 134, 86, 75) | -5.5 Points on EORTC scale | Standard Deviation 15.04 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 109 (n= 44, 39, 14) | -1.0 Points on EORTC scale | Standard Deviation 3.56 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning | Week 25 (n= 144, 97, 75) | -3.6 Points on EORTC scale | Standard Deviation 16.19 |
Secondary
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning
Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Time frame: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157
Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 31 (n= 123, 92, 51) | -0.7 Points on EORTC scale | Standard Deviation 21.38 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 139 (n= 20, 19, 6) | -5.8 Points on EORTC scale | Standard Deviation 9.79 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 7 (n= 239, 183, 218) | -3.6 Points on EORTC scale | Standard Deviation 24.21 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 85 (n= 68, 51, 18) | -2.2 Points on EORTC scale | Standard Deviation 16.26 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 43 (n= 103, 74, 44) | 1.0 Points on EORTC scale | Standard Deviation 20.85 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 37 (n= 116, 88, 48) | 1.6 Points on EORTC scale | Standard Deviation 22.94 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 49 (n= 97, 70, 40) | 1.7 Points on EORTC scale | Standard Deviation 20.62 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 133 (n= 29, 31, 11) | 1.1 Points on EORTC scale | Standard Deviation 34.48 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 79 (n= 67, 54, 21) | -0.7 Points on EORTC scale | Standard Deviation 18.45 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 55 (n= 86, 66, 34) | 1.6 Points on EORTC scale | Standard Deviation 20.07 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 11 (n= 201, 112, 163) | -3.2 Points on EORTC scale | Standard Deviation 24.46 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 73 (n= 67, 54, 19) | 0.5 Points on EORTC scale | Standard Deviation 19.24 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 61 (n= 85, 61, 31) | 0.4 Points on EORTC scale | Standard Deviation 19.58 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 157 (n= 1, 3, 0) | 0.0 Points on EORTC scale | — |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 67 (n= 76, 61, 29) | 0.7 Points on EORTC scale | Standard Deviation 19.33 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 127 (n= 47, 36, 17) | 1.4 Points on EORTC scale | Standard Deviation 24.03 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 13 (n= 195, 106, 130) | -3.1 Points on EORTC scale | Standard Deviation 24.15 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 151 (n= 7, 7, 1) | 7.1 Points on EORTC scale | Standard Deviation 26.97 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 121 (n= 44, 39, 16) | 0.4 Points on EORTC scale | Standard Deviation 28.41 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 17 (n= 158, 84, 104) | -3.2 Points on EORTC scale | Standard Deviation 26.14 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 97 (n= 58, 49, 17) | 0.6 Points on EORTC scale | Standard Deviation 23.77 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 115 (n= 44, 36, 17) | 1.1 Points on EORTC scale | Standard Deviation 22.27 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 19 (n= 164, 96, 98) | -1.3 Points on EORTC scale | Standard Deviation 24.56 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 109 (n= 44, 39, 14) | 1.1 Points on EORTC scale | Standard Deviation 21.98 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 23 (n= 134, 86, 75) | -2.6 Points on EORTC scale | Standard Deviation 25.76 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 145 (n= 14, 14, 6) | -6.0 Points on EORTC scale | Standard Deviation 34.96 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 103 (n= 53, 46, 17) | -0.6 Points on EORTC scale | Standard Deviation 26.95 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 25 (n= 144, 97, 75) | 0.7 Points on EORTC scale | Standard Deviation 21.13 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 5 (n= 233, 183, 221) | -4.1 Points on EORTC scale | Standard Deviation 23.71 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 91 (n= 62, 53, 16) | 1.1 Points on EORTC scale | Standard Deviation 22.76 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 157 (n= 1, 3, 0) | -11.1 Points on EORTC scale | Standard Deviation 19.25 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 19 (n= 164, 96, 98) | -4.3 Points on EORTC scale | Standard Deviation 25.04 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 5 (n= 233, 183, 221) | -6.8 Points on EORTC scale | Standard Deviation 24.9 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 7 (n= 239, 183, 218) | -11.6 Points on EORTC scale | Standard Deviation 28.25 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 11 (n= 201, 112, 163) | -9.7 Points on EORTC scale | Standard Deviation 28.97 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 13 (n= 195, 106, 130) | -8.3 Points on EORTC scale | Standard Deviation 25.33 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 17 (n= 158, 84, 104) | -11.1 Points on EORTC scale | Standard Deviation 27.05 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 23 (n= 134, 86, 75) | -6.4 Points on EORTC scale | Standard Deviation 24.14 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 25 (n= 144, 97, 75) | -7.7 Points on EORTC scale | Standard Deviation 23.7 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 31 (n= 123, 92, 51) | -3.1 Points on EORTC scale | Standard Deviation 24.82 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 37 (n= 116, 88, 48) | -3.2 Points on EORTC scale | Standard Deviation 26.37 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 43 (n= 103, 74, 44) | -3.4 Points on EORTC scale | Standard Deviation 26.46 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 49 (n= 97, 70, 40) | -1.2 Points on EORTC scale | Standard Deviation 21.67 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 55 (n= 86, 66, 34) | -4.8 Points on EORTC scale | Standard Deviation 21.03 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 61 (n= 85, 61, 31) | -3.0 Points on EORTC scale | Standard Deviation 24.82 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 67 (n= 76, 61, 29) | -4.6 Points on EORTC scale | Standard Deviation 25.84 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 73 (n= 67, 54, 19) | -5.6 Points on EORTC scale | Standard Deviation 26.7 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 79 (n= 67, 54, 21) | -8.3 Points on EORTC scale | Standard Deviation 27.99 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 85 (n= 68, 51, 18) | -9.8 Points on EORTC scale | Standard Deviation 28.9 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 91 (n= 62, 53, 16) | -10.7 Points on EORTC scale | Standard Deviation 29.25 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 97 (n= 58, 49, 17) | -7.5 Points on EORTC scale | Standard Deviation 26.8 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 103 (n= 53, 46, 17) | -9.8 Points on EORTC scale | Standard Deviation 23.46 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 109 (n= 44, 39, 14) | -5.6 Points on EORTC scale | Standard Deviation 22.73 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 115 (n= 44, 36, 17) | -10.6 Points on EORTC scale | Standard Deviation 28.77 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 121 (n= 44, 39, 16) | -8.1 Points on EORTC scale | Standard Deviation 26.73 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 127 (n= 47, 36, 17) | -6.0 Points on EORTC scale | Standard Deviation 26.17 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 133 (n= 29, 31, 11) | -4.3 Points on EORTC scale | Standard Deviation 24.33 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 139 (n= 20, 19, 6) | -8.8 Points on EORTC scale | Standard Deviation 18.73 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 145 (n= 14, 14, 6) | -10.7 Points on EORTC scale | Standard Deviation 16.8 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 151 (n= 7, 7, 1) | -14.3 Points on EORTC scale | Standard Deviation 17.82 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 97 (n= 58, 49, 17) | 0.0 Points on EORTC scale | Standard Deviation 13.18 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 23 (n= 134, 86, 75) | -8.4 Points on EORTC scale | Standard Deviation 24.56 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 139 (n= 20, 19, 6) | 8.3 Points on EORTC scale | Standard Deviation 13.94 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 103 (n= 53, 46, 17) | 2.0 Points on EORTC scale | Standard Deviation 10 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 19 (n= 164, 96, 98) | -6.1 Points on EORTC scale | Standard Deviation 24.8 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 109 (n= 44, 39, 14) | 4.8 Points on EORTC scale | Standard Deviation 10.19 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 17 (n= 158, 84, 104) | -6.3 Points on EORTC scale | Standard Deviation 20.27 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 43 (n= 103, 74, 44) | -1.1 Points on EORTC scale | Standard Deviation 19.49 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 115 (n= 44, 36, 17) | 2.0 Points on EORTC scale | Standard Deviation 11.61 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 13 (n= 195, 106, 130) | -6.9 Points on EORTC scale | Standard Deviation 25.65 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 145 (n= 14, 14, 6) | 0.0 Points on EORTC scale | Standard Deviation 23.57 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 121 (n= 44, 39, 16) | 2.1 Points on EORTC scale | Standard Deviation 14.75 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 11 (n= 201, 112, 163) | -6.1 Points on EORTC scale | Standard Deviation 24.56 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 85 (n= 68, 51, 18) | 0.9 Points on EORTC scale | Standard Deviation 12.09 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 61 (n= 85, 61, 31) | 1.1 Points on EORTC scale | Standard Deviation 21.05 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 127 (n= 47, 36, 17) | 1.0 Points on EORTC scale | Standard Deviation 7.15 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 67 (n= 76, 61, 29) | -1.7 Points on EORTC scale | Standard Deviation 17.45 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 55 (n= 86, 66, 34) | 1.0 Points on EORTC scale | Standard Deviation 16.89 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 7 (n= 239, 183, 218) | -4.9 Points on EORTC scale | Standard Deviation 22.44 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 73 (n= 67, 54, 19) | -0.9 Points on EORTC scale | Standard Deviation 17.1 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 49 (n= 97, 70, 40) | -2.1 Points on EORTC scale | Standard Deviation 21.08 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 31 (n= 123, 92, 51) | -3.9 Points on EORTC scale | Standard Deviation 23.24 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 79 (n= 67, 54, 21) | -2.4 Points on EORTC scale | Standard Deviation 12.12 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 37 (n= 116, 88, 48) | -3.1 Points on EORTC scale | Standard Deviation 21.92 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 133 (n= 29, 31, 11) | -1.5 Points on EORTC scale | Standard Deviation 11.68 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 25 (n= 144, 97, 75) | -7.8 Points on EORTC scale | Standard Deviation 23.78 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 5 (n= 233, 183, 221) | -4.4 Points on EORTC scale | Standard Deviation 21.18 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 91 (n= 62, 53, 16) | 2.1 Points on EORTC scale | Standard Deviation 13.44 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning | Week 151 (n= 7, 7, 1) | 0.0 Points on EORTC scale | — |
Secondary
Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning
Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.
Time frame: Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157
Population: All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 139 (n= 20, 19, 6) | 4.2 Points on EORTC scale | Standard Deviation 10.64 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 103 (n= 53, 46, 17) | -0.6 Points on EORTC scale | Standard Deviation 17.28 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 43 (n= 103, 74, 44) | -0.2 Points on EORTC scale | Standard Deviation 20.68 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 13 (n= 195, 106, 130) | 0.6 Points on EORTC scale | Standard Deviation 22.73 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 97 (n= 58, 49, 17) | -0.3 Points on EORTC scale | Standard Deviation 16.95 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 49 (n= 97, 70, 40) | 2.4 Points on EORTC scale | Standard Deviation 17.35 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 151 (n= 7, 7, 1) | 7.1 Points on EORTC scale | Standard Deviation 23.29 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 91 (n= 62, 53, 16) | -0.8 Points on EORTC scale | Standard Deviation 17.96 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 55 (n= 86, 66, 34) | 0.6 Points on EORTC scale | Standard Deviation 19.21 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 133 (n= 29, 31, 11) | 0.6 Points on EORTC scale | Standard Deviation 15.74 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 85 (n= 68, 51, 18) | 1.0 Points on EORTC scale | Standard Deviation 13.77 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 61 (n= 85, 61, 31) | 2.7 Points on EORTC scale | Standard Deviation 16.44 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 17 (n= 158, 84, 104) | -0.9 Points on EORTC scale | Standard Deviation 22.28 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 79 (n= 67, 54, 21) | 1.2 Points on EORTC scale | Standard Deviation 14.01 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 67 (n= 76, 61, 29) | 1.8 Points on EORTC scale | Standard Deviation 16.46 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 7 (n= 239, 183, 218) | -0.1 Points on EORTC scale | Standard Deviation 20.58 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 73 (n= 67, 54, 19) | 1.5 Points on EORTC scale | Standard Deviation 17.58 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 127 (n= 47, 36, 17) | 3.5 Points on EORTC scale | Standard Deviation 18.37 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 19 (n= 164, 96, 98) | 1.4 Points on EORTC scale | Standard Deviation 21.4 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 5 (n= 233, 183, 221) | -1.2 Points on EORTC scale | Standard Deviation 21.99 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 121 (n= 44, 39, 16) | 3.4 Points on EORTC scale | Standard Deviation 19.88 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 23 (n= 134, 86, 75) | -0.1 Points on EORTC scale | Standard Deviation 19.87 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 145 (n= 14, 14, 6) | -8.3 Points on EORTC scale | Standard Deviation 26.75 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 115 (n= 44, 36, 17) | 3.8 Points on EORTC scale | Standard Deviation 18.63 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 25 (n= 144, 97, 75) | 1.2 Points on EORTC scale | Standard Deviation 19.77 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 11 (n= 201, 112, 163) | -0.6 Points on EORTC scale | Standard Deviation 22.32 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 109 (n= 44, 39, 14) | 4.2 Points on EORTC scale | Standard Deviation 15.72 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 31 (n= 123, 92, 51) | 3.5 Points on EORTC scale | Standard Deviation 16.84 |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 157 (n= 1, 3, 0) | 0.0 Points on EORTC scale | — |
| Nivolumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 37 (n= 116, 88, 48) | 1.6 Points on EORTC scale | Standard Deviation 18.12 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 109 (n= 44, 39, 14) | -2.6 Points on EORTC scale | Standard Deviation 20.43 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 121 (n= 44, 39, 16) | -3.0 Points on EORTC scale | Standard Deviation 25.33 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 5 (n= 233, 183, 221) | -4.6 Points on EORTC scale | Standard Deviation 21.76 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 7 (n= 239, 183, 218) | -5.8 Points on EORTC scale | Standard Deviation 21.81 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 11 (n= 201, 112, 163) | -5.1 Points on EORTC scale | Standard Deviation 22.02 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 13 (n= 195, 106, 130) | -3.6 Points on EORTC scale | Standard Deviation 20.57 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 17 (n= 158, 84, 104) | -4.4 Points on EORTC scale | Standard Deviation 25.1 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 19 (n= 164, 96, 98) | -1.7 Points on EORTC scale | Standard Deviation 23.13 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 23 (n= 134, 86, 75) | -1.2 Points on EORTC scale | Standard Deviation 23.4 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 25 (n= 144, 97, 75) | -3.4 Points on EORTC scale | Standard Deviation 21.37 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 31 (n= 123, 92, 51) | 0.2 Points on EORTC scale | Standard Deviation 20.3 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 37 (n= 116, 88, 48) | 1.1 Points on EORTC scale | Standard Deviation 22.71 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 43 (n= 103, 74, 44) | 2.9 Points on EORTC scale | Standard Deviation 21.43 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 49 (n= 97, 70, 40) | 3.1 Points on EORTC scale | Standard Deviation 19.92 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 55 (n= 86, 66, 34) | 0.0 Points on EORTC scale | Standard Deviation 21.68 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 61 (n= 85, 61, 31) | -0.5 Points on EORTC scale | Standard Deviation 22.76 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 67 (n= 76, 61, 29) | -0.8 Points on EORTC scale | Standard Deviation 24.8 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 73 (n= 67, 54, 19) | -2.5 Points on EORTC scale | Standard Deviation 17.85 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 79 (n= 67, 54, 21) | -3.4 Points on EORTC scale | Standard Deviation 24.31 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 85 (n= 68, 51, 18) | -7.5 Points on EORTC scale | Standard Deviation 21.68 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 91 (n= 62, 53, 16) | -5.7 Points on EORTC scale | Standard Deviation 24.23 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 97 (n= 58, 49, 17) | -2.7 Points on EORTC scale | Standard Deviation 22.14 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 103 (n= 53, 46, 17) | -4.3 Points on EORTC scale | Standard Deviation 22.62 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 115 (n= 44, 36, 17) | -2.3 Points on EORTC scale | Standard Deviation 25.56 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 127 (n= 47, 36, 17) | -2.3 Points on EORTC scale | Standard Deviation 22.24 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 133 (n= 29, 31, 11) | -2.2 Points on EORTC scale | Standard Deviation 26.44 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 139 (n= 20, 19, 6) | -4.4 Points on EORTC scale | Standard Deviation 19.12 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 145 (n= 14, 14, 6) | -11.9 Points on EORTC scale | Standard Deviation 16.57 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 151 (n= 7, 7, 1) | -9.5 Points on EORTC scale | Standard Deviation 16.27 |
| Nivolumab + Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 157 (n= 1, 3, 0) | -22.2 Points on EORTC scale | Standard Deviation 19.25 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 139 (n= 20, 19, 6) | 2.8 Points on EORTC scale | Standard Deviation 16.39 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 97 (n= 58, 49, 17) | 0.0 Points on EORTC scale | Standard Deviation 0 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 37 (n= 116, 88, 48) | 3.1 Points on EORTC scale | Standard Deviation 18.4 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 7 (n= 239, 183, 218) | -0.2 Points on EORTC scale | Standard Deviation 21.79 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 103 (n= 53, 46, 17) | -1.0 Points on EORTC scale | Standard Deviation 4.04 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 25 (n= 144, 97, 75) | -1.3 Points on EORTC scale | Standard Deviation 25.23 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 31 (n= 123, 92, 51) | 3.6 Points on EORTC scale | Standard Deviation 22.68 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 23 (n= 134, 86, 75) | -4.2 Points on EORTC scale | Standard Deviation 21.94 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 151 (n= 7, 7, 1) | 0 Points on EORTC scale | — |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 115 (n= 44, 36, 17) | 0.0 Points on EORTC scale | Standard Deviation 5.89 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 19 (n= 164, 96, 98) | -1.3 Points on EORTC scale | Standard Deviation 24.71 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 121 (n= 44, 39, 16) | -1.0 Points on EORTC scale | Standard Deviation 4.17 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 17 (n= 158, 84, 104) | -2.9 Points on EORTC scale | Standard Deviation 18.06 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 145 (n= 14, 14, 6) | 2.8 Points on EORTC scale | Standard Deviation 16.39 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 127 (n= 47, 36, 17) | 2.0 Points on EORTC scale | Standard Deviation 5.54 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 13 (n= 195, 106, 130) | -2.2 Points on EORTC scale | Standard Deviation 24.41 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 67 (n= 76, 61, 29) | -2.3 Points on EORTC scale | Standard Deviation 17.66 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 5 (n= 233, 183, 221) | -1.6 Points on EORTC scale | Standard Deviation 21.59 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 73 (n= 67, 54, 19) | -8.8 Points on EORTC scale | Standard Deviation 18.73 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 61 (n= 85, 61, 31) | 5.9 Points on EORTC scale | Standard Deviation 17.51 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 133 (n= 29, 31, 11) | 3.0 Points on EORTC scale | Standard Deviation 10.05 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 79 (n= 67, 54, 21) | 0.8 Points on EORTC scale | Standard Deviation 3.64 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 55 (n= 86, 66, 34) | 5.9 Points on EORTC scale | Standard Deviation 17.83 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 11 (n= 201, 112, 163) | -3.4 Points on EORTC scale | Standard Deviation 21.53 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 85 (n= 68, 51, 18) | -1.9 Points on EORTC scale | Standard Deviation 7.86 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 49 (n= 97, 70, 40) | 6.3 Points on EORTC scale | Standard Deviation 18.37 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 109 (n= 44, 39, 14) | -3.6 Points on EORTC scale | Standard Deviation 9.65 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 91 (n= 62, 53, 16) | 1.0 Points on EORTC scale | Standard Deviation 4.17 |
| Ipilimumab | Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning | Week 43 (n= 103, 74, 44) | 4.2 Points on EORTC scale | Standard Deviation 22.77 |
Secondary
Objective Response Rate (ORR) Per Investigator Assessment
The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \>=50% of previously involved sites from nadir.
Time frame: From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab | Objective Response Rate (ORR) Per Investigator Assessment | 44.9 Percentage of participants |
| Nivolumab + Ipilimumab | Objective Response Rate (ORR) Per Investigator Assessment | 58.3 Percentage of participants |
| Ipilimumab | Objective Response Rate (ORR) Per Investigator Assessment | 19.0 Percentage of participants |
p-value: <0.000195% CI: [2.49, 5.16]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [4.38, 9.22]Cochran-Mantel-Haenszel
95% CI: [19.1, 32.8]
95% CI: [32.2, 45.9]
95% CI: [1.26, 2.42]
95% CI: [5.7, 20.7]
Secondary
Overall Survival Based on PD-L1 Expression Level
OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time frame: From randomization until death (assessed up to approximately 128 months)
Population: All randomized participants with evaluable PD-L1 expression level at baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 1% (n= 171, 155, 164) | 85.09 months |
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 10% (n= 59, 46, 54) | 43.63 months |
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 5% (n= 80, 68, 75) | 64.51 months |
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 1% (n=117, 123, 113) | 23.46 months |
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 5% (n= 208, 210, 202) | 35.94 months |
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38) | 23.89 months |
| Nivolumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 10% (n= 229, 232, 223) | 36.93 months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 10% (n= 59, 46, 54) | NA months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38) | NA months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 1% (n=117, 123, 113) | NA months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 1% (n= 171, 155, 164) | 82.30 months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 10% (n= 229, 232, 223) | 70.74 months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 5% (n= 208, 210, 202) | 65.94 months |
| Nivolumab + Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 5% (n= 80, 68, 75) | 104.97 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 1% (n= 171, 155, 164) | 21.49 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38) | 18.73 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 5% (n= 80, 68, 75) | 28.88 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 1% (n=117, 123, 113) | 18.56 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 10% (n= 229, 232, 223) | 18.56 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 >= 10% (n= 59, 46, 54) | 29.08 months |
| Ipilimumab | Overall Survival Based on PD-L1 Expression Level | PD-L1 < 5% (n= 208, 210, 202) | 18.40 months |
95% CI: [0.57, 1.05]
95% CI: [0.43, 0.81]
95% CI: [0.55, 1.04]
95% CI: [0.39, 0.68]
95% CI: [0.38, 0.67]
95% CI: [0.72, 1.31]
95% CI: [0.49, 0.78]
95% CI: [0.41, 0.66]
95% CI: [0.66, 1.08]
95% CI: [0.41, 0.91]
95% CI: [0.38, 0.91]
95% CI: [0.62, 1.53]
95% CI: [0.48, 0.75]
95% CI: [0.43, 0.68]
95% CI: [0.71, 1.14]
95% CI: [0.44, 1.1]
95% CI: [0.32, 0.91]
95% CI: [0.45, 1.32]
95% CI: [0.37, 1.34]
95% CI: [0.26, 0.91]
95% CI: [0.34, 1.39]
Secondary
Overall Survival (OS)
OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time frame: From randomization until death (assessed up to approximately 128 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab | Overall Survival (OS) | 36.93 months |
| Nivolumab + Ipilimumab | Overall Survival (OS) | 71.92 months |
| Ipilimumab | Overall Survival (OS) | 19.94 months |
95% CI: [0.69, 1.05]
Secondary
Progression-Free Survival Based on PD-L1 Expression Level
PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 \>=5% or PD-L1 \<5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.
Time frame: From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)
Population: All randomized participants with evaluable PD-L1 expression level at baseline
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 1% (n= 171, 155, 164) | 16.20 months |
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 10% (n= 229, 232, 223) | 5.62 months |
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 5% (n= 80, 68, 75) | 22.34 months |
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 1% (n=117, 123, 113) | 2.83 months |
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38) | 2.99 months |
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 10% (n= 59, 46, 54) | 21.98 months |
| Nivolumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 5% (n= 208, 210, 202) | 5.32 months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 5% (n= 80, 68, 75) | 22.11 months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 1% (n=117, 123, 113) | 11.17 months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 1% (n= 171, 155, 164) | 16.72 months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 5% (n= 208, 210, 202) | 11.17 months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 10% (n= 229, 232, 223) | 11.10 months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 10% (n= 59, 46, 54) | NA months |
| Nivolumab + Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38) | 6.93 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 10% (n= 229, 232, 223) | 2.83 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 1% (n= 171, 155, 164) | 3.48 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 Indeterminate/ Not Evaluable (n= 28, 36, 38) | 2.83 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 10% (n= 59, 46, 54) | 4.11 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 >= 5% (n= 80, 68, 75) | 3.94 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 5% (n= 208, 210, 202) | 2.83 months |
| Ipilimumab | Progression-Free Survival Based on PD-L1 Expression Level | PD-L1 < 1% (n=117, 123, 113) | 2.76 months |
95% CI: [0.22, 0.54]
95% CI: [0.54, 1.38]
95% CI: [0.46, 0.85]
95% CI: [0.28, 0.54]
95% CI: [0.45, 0.87]
95% CI: [0.34, 0.59]
95% CI: [0.3, 0.53]
95% CI: [0.66, 1.21]
95% CI: [0.45, 0.71]
95% CI: [0.33, 0.53]
95% CI: [0.57, 0.94]
95% CI: [0.27, 0.6]
95% CI: [0.43, 0.67]
95% CI: [0.34, 0.54]
95% CI: [0.63, 1.01]
95% CI: [0.28, 0.73]
95% CI: [0.16, 0.49]
95% CI: [0.34, 1.09]
95% CI: [0.49, 1.52]
95% CI: [0.3, 0.89]
95% CI: [0.33, 1.09]
Secondary
Progression Free Survival (PFS)
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Time frame: From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab | Progression Free Survival (PFS) | 6.93 months |
| Nivolumab + Ipilimumab | Progression Free Survival (PFS) | 11.50 months |
| Ipilimumab | Progression Free Survival (PFS) | 2.86 months |
95% CI: [0.65, 0.96]