Trial Outcomes & Findings for Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC (NCT NCT04375150)
NCT ID: NCT04375150
Last Updated: 2024-09-19
Results Overview
Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Recruitment status
COMPLETED
Target enrollment
355 participants
Primary outcome timeframe
At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months
Results posted on
2024-09-19
Participant Flow
Participants diagnosed with advanced/metastatic renal cell carcinoma (RCC) who initiated treatment for aRCC between 1-Apr-2018 and 31-Jul-2022 were observed. Data was collected retrospectively from various real world claims databases (Truven, Optum, Pharmetrics and the PanTher). Index date was the date of initiation of the aRCC treatment. Data was collected and observed for approximately 35 months (02 December 2019 to 28 October 2022) of this study.
A total of 355 participants were included in the study.
Participant milestones
| Measure |
Axitinib + Pembrolizumab
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
340
|
15
|
|
Overall Study
COMPLETED
|
340
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC
Baseline characteristics by cohort
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.13 Years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
66.87 Years
STANDARD_DEVIATION 10.45 • n=7 Participants
|
64.25 Years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
235 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
237 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
79 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
90 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants With First Line Treatment Regimen
|
340 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for specified rows.
Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants With Monotherapy and Combination Therapy
Monotherapy- First Line
|
0 Participants
|
0 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Monotherapy- Second Line
|
97 Participants
|
6 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Monotherapy- Third Line
|
21 Participants
|
1 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Monotherapy- Fourth Line
|
4 Participants
|
1 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Monotherapy- Fifth Line
|
5 Participants
|
1 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Monotherapy- Sixth Line
|
1 Participants
|
—
|
|
Number of Participants With Monotherapy and Combination Therapy
Combination therapy- First Line
|
340 Participants
|
15 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Combination therapy- Second Line
|
51 Participants
|
2 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Combination therapy- Third Line
|
30 Participants
|
2 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Combination therapy- Fourth Line
|
10 Participants
|
0 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Combination therapy- Fifth Line
|
0 Participants
|
0 Participants
|
|
Number of Participants With Monotherapy and Combination Therapy
Combination therapy- Sixth Line
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Time to First Line Therapy
|
29.00 Days
Interval 18.0 to 52.0
|
25.00 Days
Interval 20.0 to 56.0
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Duration of Treatment According to Each Line of Therapy
First Line Therapy
|
11.97 Days
Interval 4.85 to 22.05
|
5.90 Days
Interval 2.8 to 16.27
|
|
Duration of Treatment According to Each Line of Therapy
Second Line Therapy
|
5.38 Days
Interval 2.5 to 11.7
|
2.58 Days
Interval 1.32 to 4.03
|
|
Duration of Treatment According to Each Line of Therapy
Third Line Therapy
|
4.03 Days
Interval 2.1 to 7.03
|
3.43 Days
Interval 1.27 to 11.33
|
|
Duration of Treatment According to Each Line of Therapy
Fourth Line Therapy
|
2.75 Days
Interval 1.43 to 6.07
|
3.57 Days
Interval 3.57 to 3.57
|
|
Duration of Treatment According to Each Line of Therapy
Fifth Line Therapy
|
2.53 Days
Interval 2.37 to 3.93
|
0.90 Days
Interval 0.9 to 0.9
|
|
Duration of Treatment According to Each Line of Therapy
Sixth Line Therapy
|
4.03 Days
Interval 4.03 to 4.03
|
—
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Treatment continuation was considered when there was no more than (\>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants With Treatment Continuation
|
21 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants With Treatment Interruption
|
171 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signified participants evaluable for this outcome measure.
Time from index medication to treatment discontinuation for those within treatment interruptions (\>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=171 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=6 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Time to Treatment Interruption
|
2.10 Months
Interval 0.7 to 4.2
|
1.05 Months
Interval 0.43 to 2.55
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants With Treatment Switch or Augmentation
Treatment Switch
|
146 Participants
|
8 Participants
|
|
Number of Participants With Treatment Switch or Augmentation
Treatment Augmentation
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants According to Lines of Therapy
First Line Therapy
|
340 Participants
|
15 Participants
|
|
Number of Participants According to Lines of Therapy
Second Line Therapy
|
148 Participants
|
8 Participants
|
|
Number of Participants According to Lines of Therapy
Third Line Therapy
|
51 Participants
|
3 Participants
|
|
Number of Participants According to Lines of Therapy
Fourth Line Therapy
|
14 Participants
|
1 Participants
|
|
Number of Participants According to Lines of Therapy
Fifth Line Therapy
|
5 Participants
|
1 Participants
|
|
Number of Participants According to Lines of Therapy
Sixth Line Therapy
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Leuprolide/ Bicalutamide,Leuprolide
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Nivolumab/ Cabozantinib
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Nivolumab/ Cabozantinib,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Pazopanib
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Pazopanib/ Cabozantinib/ Everolimus,Lenvatinib/ Sunitinib/ Tivozanib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Pazopanib/ Cabozantinib,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Pazopanib/ Everolimus,Lenvatinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Axitinib,Pembrolizumab/ Ipilimumab,Nivolumab/ CSD
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Ipilimumab,Nivolumab/ Everolimus,Lenvatinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Lenvatinib
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Lenvatinib, Pembrolizumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus/ Pazopanib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus,Lenvatinib
|
5 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus,Lenvatinib/ Cabozantinib/ Everolimus
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus,Lenvatinib/ Cabozantinib,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus,Lenvatinib/ Ipilimumab,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Everolimus,Lenvatinib,Pembrolizumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Gemcitabine,Paclitaxel Protein-Bound,Pembrolizumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Hydroxyurea,Pembrolizumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Ipilimumab,Nivolumab
|
9 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Ipilimumab,Nivolumab/ Cabozantinib
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Ipilimumab,Nivolumab/ Cabozantinib,Ipilimumab,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib,Nivolumab,PEM/ Everolimus,Lenvatinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib,PEM
|
6 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/Chlorambucil,Obinutuzumab/ Rituximab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ CSD
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ CSD/ Cabozantinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI,PEM/ CSD,Cyclophosphamide,Daratumumab/Hyaluronidase- Fihj,Fludarabine/ Cabozantinib,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ CSD,Cyclophosphamide,Fludarabine/ Cabozantinib,Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Axitinib,Pembrolizumab/CSD,Gemcitabine
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM-Doxorubicin,PEM/ Cabozantinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ PEM
|
7 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ PEM,Sunitinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Sunitinib/ Pembrolizumab,Sunitinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Sunitinib/Tivozanib/ Cabozantinib/ Tivozanib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib
|
48 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab,Axitinib
|
0 Participants
|
7 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab, Axitinib/ Axitinib, Pembrolizumab
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab, Axitinib/ Cabozantinib
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab,Axitinib/ Cabozantinib/ Cabozantinib, Nivolumab/ Tivozanib/ Pazopanib
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab,Axitinib/ Cabozantinib/ Everolimus, Lenvatinib
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab,Axitinib/ Cabozantinib/ Pazopanib
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab, Axitinib/ Ipilimumab, Nivolumab
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab, Axitinib/ Nivolumab
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Avelumab, Axitinib/ Pembrolizumab
|
0 Participants
|
1 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Axitinib,Pembrolizumab
|
192 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Axitinib,Pembrolizumab/ Axitinib (PEM-AXI), leuprolide, Pembrolizumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI,PEM/ AXI,Leuprolide,PEM/ Abiraterone,AXI,PEM/Abiraterone,Axitinib,Leuprolide, PEM
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ AXI, PEM/ Cabozantinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Bevacizumab/ Cabozantinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Bevacizumab- Awwb/ Bevacizumab/ Temsirolimus/ Bevacizumab- Awwb
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Bevacizumab-Awwb/ Cabozantinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Bevacizumab-Awwb, Everolimus
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/Bevacizumab- Awwb
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/Cabozantinib, Nivolumab
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Cabozantinib, PEM/ Everolimus, Lenvatinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Clinical Study Drug (CSD)/ Everolimus, Lenvatinib/ Belzutifan
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib
|
4 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib/ Bevacizumab -Bvzr, Erlotinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib/ CSD
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Everolimus,Lenvatinib/ Ipilimumab, Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib, Tivozanib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Ipilimumab, Nivolumab
|
2 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Ipilimumab, Nivolumab/ Everolimus, Lenvatinib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Pazopanib/ Ipilimumab, Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/ Pazopanib- Lenvatinib, Pembrolizumab/ Tivozanib
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib/Tivozanib/ Ipilimumab, Nivolumab
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib,CSD
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib,Nivolumab
|
6 Participants
|
0 Participants
|
|
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
AXI, PEM/ Cabozantinib,Nivolumab/ Everolimus,Lenvatinib
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)Population: All eligible participants whose data were retrieved and observed in this study.
Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Number of Participants According to Their Status at End of Follow-up
Death
|
161 Participants
|
11 Participants
|
|
Number of Participants According to Their Status at End of Follow-up
End of enrollment
|
104 Participants
|
2 Participants
|
|
Number of Participants According to Their Status at End of Follow-up
End of data availability
|
75 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Time to Treatment Failure (TTF)
|
2.57 Months
Interval 2.1 to 2.9
|
1.83 Months
Interval 0.93 to 4.37
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Percentage of Participants With Treatment Discontinuation
|
80 Percentage of participants
|
80 Percentage of participants
|
PRIMARY outcome
Timeframe: At 3 months (data collected and observed retrospectively over 35 months)Population: All eligible participants whose data were retrieved and observed in this study.
Percentage of participants who were alive at 3 months is reported in this outcome measure.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Percentage of Participants Alive at 3 Months
|
90.29 Percentage of participants
|
86.67 Percentage of participants
|
PRIMARY outcome
Timeframe: At 3 months (data collected and observed retrospectively over 35 months)Population: All eligible participants whose data were retrieved and observed in this study.
Percentage of participants who were alive at 6 months is reported in this outcome measure.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Percentage of Participants Alive at 6 Months
|
82.35 Percentage of participants
|
66.67 Percentage of participants
|
PRIMARY outcome
Timeframe: At 3 months (data collected and observed retrospectively over 35 months)Population: All eligible participants whose data were retrieved and observed in this study.
Percentage of participants who were alive at 12 months is reported in this outcome measure.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Percentage of Participants Alive at 12 Months
|
67.35 Percentage of participants
|
40.00 Percentage of participants
|
PRIMARY outcome
Timeframe: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 monthsPopulation: All eligible participants whose data were retrieved and observed in this study.
OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment.
Outcome measures
| Measure |
Axitinib + Pembrolizumab
n=340 Participants
Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
Axitinib + Avelumab
n=15 Participants
Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.
|
|---|---|---|
|
Overall Survival
|
29.43 Days
Interval 24.17 to 37.53
|
11.97 Days
Interval 4.83 to 28.47
|
Adverse Events
Axitinib + Pembrolizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 161 deaths
Axitinib + Avelumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER