Carcinoma, Renal Cell
Conditions
Keywords
Axitinib, Renal cell carcinoma, Avelumab, BAVENCIO®, INLYTA®
Brief summary
The main purpose of this study is to expand knowledge on the effectiveness of Avelumab intravenous infusion in combination with Axitinib as the first-line therapy in participants with advanced renal-cell carcinoma (aRCC) in addition to the safety and tolerability under routine conditions of daily clinical practice.
Interventions
None listed
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Participants with a histologically confirmed diagnosis of RCC with any histological origin * Participants with a locally advanced/metastatic disease (that is \[ie\], newly diagnosed Stage 4 RCC per American Joint Committee on Cancer) or has recurrent disease * Participants has received 1 or 2 cycles of Avelumab plus Axitinib treatment as a first-line therapy according to the approved Summary of Product Characteristics (SmPC) * Participants willing to sign the written informed consent form (ICF) to participate in this study
Exclusion criteria
* Participants with contraindications for Avelumab or Axitinib according to the approved SmPC * Participants who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of Avelumab plus Axitinib
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate | At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF]) | Overall survival rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate | At 24 months after index date (baseline visit as reported in the eCRF) | Overall survival rate was defined as the percentage of participants who are alive at 24 months after the index date. Percentage of participants alive at the time of outcome assessment (24 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Duration of Overall Survival | From the index date (baseline visit as reported in the eCRF) to the date of death from any cause, (assessed up to 24 months after index date) | Duration of overall survival is defined as the time from index date to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date | up to 24 months after the index date (baseline visit as reported in the eCRF) | Objective response rate was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) as best overall response up to 24 months after the index date. CR: Disappearance of all target and non-target lesions. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of their diameters, and no unequivocal progression of non-target lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date | up to 24 months after the index date (baseline visit as reported in the eCRF) | Disease control rate is defined as the percentage of participants with objective response (complete response \[CR\] or partial response \[PR\] or stable disease \[SD\]) as best overall response up to 24 months after the index date. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD while on study. PD is defined as at least a 20 % increase in the SLD of target lesion, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | up to 24 months after the index date (baseline visit as reported in the eCRF) | DoR was defined for participants with objective response, as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator | From the index date (baseline visit as reported in the eCRF) to the date of disease progression or death from any cause, whichever occurred first (assessed up to 24 months after index date) | PFS time was defined as the time from index date to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered PD. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. PFS was calculated based on KM method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator | From the index date (baseline visit as reported in the eCRF) to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 24 months after index date) | PFS2 was defined as time interval from the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The tumor response will be determined according to RECIST version 1.1 and assessed by the investigator. PFS2 was calculated based on Kaplan Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | Index date (baseline visit as reported in the eCRF), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 and 104 weeks | NCCN-FACT FKSI-19, a validated, disease-specific questionnaire for RCC. It includes 19 items across four domains, Disease-Related Symptoms-Physical (DRS-P), Disease-Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Functional Wellbeing (FWB), based on symptoms experienced over past 7 days. Responses were recorded on 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score from 0 to 76, higher scores reflecting better quality of life. A negative mean change in score indicated worsening condition. Domain score ranges and directionality: DRS-P: 0-48, higher scores = fewer physical symptoms; DRS-E: 0-4, higher = fewer emotional symptoms; TSE: 0-12, higher = more severe side effects; FWB: 0-12, higher = better functional wellbeing. As per NCCN-FACT FKSI-19 scoring guidelines, the total Health-related quality of life (HRQoL) score (range 0-76) was calculated as sum of single items scores multiplied by 19 and divided by the number of items completed. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA) | From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs were defined as events with onset date or worsening during the on-treatment period. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs is defined as reasonably related to the study intervention. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Number of Participants With Adverse Events Based on Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 | From the index date (baseline visit as reported in the eCRF) up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occurred first | Severity of TEAEs were evaluated using the NCI-CTCAE version 5.0. The grade are as follows: grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE. Number of participants with TEAEs grade greater than or equal to (\>=) 3 were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3 | From the index date (baseline visit as reported in the eCRF) up to 24 months | Time to therapy discontinuation due to AE \>= grade 3 was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Axitinib Due to All-Cause AEs >= Grade 3 | Time from first dose of study drug up to 24 months | The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. Duration of Avelumab plus Axitinib therapy (days) = (Date of discontinuation of Axitinib - Date of index date + 1). Duration of avelumab plus axitinib therapy among participants who discontinued the Axitinib due to all-cause AEs \>= grade 3 was reported. |
| Time to Onset of Treatment - Emergent Adverse Events (TEAEs) | From index date (baseline visit as reported in the eCRF) up to 24 months | Time to onset of TEAE = Start date TEAE - Index date. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Duration of Treatment-Emergent Adverse Events (TEAEs) | From index date (baseline visit as reported in the eCRF) up to 24 months | Duration of TEAE = (Stop date of TEAE - Start date of TEAE + 1) divided by 7. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy | From index date (baseline visit as reported in the eCRF) up to 24 months | Percentage of participants with therapy modifications due to AE related to avelumab plus axitinib therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy | From index date (baseline visit as reported in the eCRF) up to 24 months after the index date | Number of participants with different types of medical intervention or medications used for the management of TEAE related to avelumab plus axitinib therapy (e.g., use of corticosteroids, antihypertensive therapy, treatment for thyroid dysfunction, measures to decrease hemoglobin, and hematocrit) was reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Percentage of Participants Receiving Later-line Therapy | From index date (baseline visit as reported in the eCRF) up to 24 months | Percentage of participants receiving later-line therapy were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
| Time to Second-line Therapy Initiation | Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, assessed up to 24 months | Time to second line treatment was calculated as: (second line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375. |
| Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs | From index date (baseline visit as reported in the eCRF) up to 24 months | Number of participants with patient-reported potential signs and symptoms of immune-related AEs were reported. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC. |
Countries
Belgium, Germany, Greece, Russia
Contacts
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Avelumab + Axitinib Participants with advanced renal cell carcinoma (RCC) received 800 milligrams (mg) of Avelumab intravenously every 2 weeks (Q2W) in combination with 5 mg of Axitinib orally twice per day in accordance with the terms of marketing authorization for the first-line therapy as per the current clinical practice were observed for 24 months in this study. | 104 |
| Total | 104 |
Baseline characteristics
| Characteristic | Avelumab + Axitinib |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 104 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 31 / 104 |
| other Total, other adverse events | 80 / 104 |
| serious Total, serious adverse events | 37 / 104 |
Outcome results
Primary
Overall Survival (OS) Rate
OS rate was defined as the percentage of participants who are alive at 12 months after the index date. Percentage of participants alive at the time of outcome assessment (12 months) were calculated as per the Kaplan-Meier (KM) approach. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
Time frame: At 12 months after index date (baseline visit as reported in the electronic case report form [eCRF])
Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avelumab + Axitinib | Overall Survival (OS) Rate | 82.7 Percentage of Participants |
Secondary
Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score
NCCN-FACT FKSI-19, a validated, disease-specific questionnaire for RCC. It includes 19 items across four domains,Disease-Related Symptoms-Physical (DRS-P), Disease-Related Symptoms-Emotional (DRS-E), Treatment Side Effects (TSE), and Functional Wellbeing (FWB), based on symptoms experienced over past 7 days. Responses were recorded on 5-point Likert scale (0 = not at all to 4 = very much), yielding a total score from 0 to 76, higher scores reflecting better quality of life. A negative mean change in score indicated worsening condition. Domain score ranges and directionality: DRS-P: 0-48, higher scores = fewer physical symptoms; DRS-E: 0-4, higher = fewer emotional symptoms; TSE: 0-32, higher = more severe side effects; FWB: 0-12, higher = better functional wellbeing. As per NCCN-FACT FKSI-19 scoring guidelines, the total Health-related quality of life (HRQoL) score (range 0-76) was calculated as sum of single items scores multiplied by 19 and divided by the number of items completed.
Time frame: Index date (Baseline), at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 weeks
Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent. Here overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | Baseline | 58.3 scores on a scale | Standard Deviation 9.64 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 6 Weeks | -0.2 scores on a scale | Standard Deviation 8.38 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 12 Weeks | -1.1 scores on a scale | Standard Deviation 10.36 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 18 Weeks | -0.6 scores on a scale | Standard Deviation 9.42 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 24 Weeks | -0.3 scores on a scale | Standard Deviation 10.04 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 30 Weeks | -1.4 scores on a scale | Standard Deviation 10.08 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 36 Weeks | -0.4 scores on a scale | Standard Deviation 7.89 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 42 Weeks | -0.8 scores on a scale | Standard Deviation 8.58 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 48 Weeks | -0.8 scores on a scale | Standard Deviation 10.06 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 54 Weeks | -0.7 scores on a scale | Standard Deviation 10.29 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 60 Weeks | -0.4 scores on a scale | Standard Deviation 10.47 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 66 Weeks | -0.6 scores on a scale | Standard Deviation 11.21 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 72 Weeks | -1.1 scores on a scale | Standard Deviation 8.94 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 78 Weeks | -1.3 scores on a scale | Standard Deviation 8.86 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 84 Weeks | -1.0 scores on a scale | Standard Deviation 9.87 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 90 Weeks | -1.3 scores on a scale | Standard Deviation 9.67 |
| Avelumab + Axitinib | Change From Baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (NCCN-FACT FKSI-19) Total Score | 96 Weeks | 1.4 scores on a scale | Standard Deviation 9.42 |
Secondary
Disease Control Rate (DCR) Assessed by Investigator up to 24 Months After the Index Date
Time frame: up to 24 months after the index date
Secondary
Duration of All-cause AEs
Time frame: From index date up to Month 24
Secondary
Duration of Avelumab Plus Axitinib Therapy Among Participants Who Discontinued the Study Drugs Due to All-Cause AEs >= Grade 3
Time frame: Time from first dose of study drug up to Month 24
Secondary
Duration of OS
Time frame: At 24 months after index date
Secondary
Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: up to 24 months after the index date
Secondary
Number of Participants With Adverse Events (AEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: From the index date up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occured first
Secondary
Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy
Number of participants with different types of medical intervention or medications used for the management of TEAE related to avelumab plus axitinib therapy (e.g., use of corticosteroids, antihypertensive therapy, treatment for thyroid dysfunction, measures to decrease hemoglobin, and hematocrit) was reported.
Time frame: From index date upto 12 months after the index date
Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Avelumab + Axitinib | Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy | Any related TEAE managed with concomitant medications | 47 Participants |
| Avelumab + Axitinib | Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy | Any related TEAE managed with concomitant procedures | 6 Participants |
| Avelumab + Axitinib | Number of Participants With Different Types of Medical Intervention or Medications Used for the Management of TEAEs Related to Avelumab Plus Axitinib Therapy | Any related TEAE managed with corticosteroids, immunosuppressants, or hormonal therapy | 11 Participants |
Secondary
Number of Participants With Patient-reported Potential Signs and Symptoms of Immune-related AEs
Time frame: From index date up to Month 24
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs, TEAEs Leading to Permanent Treatment Discontinuation and TEAEs Leading to Death According to Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: From the index date up to 90 days post discontinuation of avelumab plus axitinib or completion of the 24 months (i.e., end of the study) follow-up from the index date, whichever occured first
Secondary
Objective Response Rate (ORR) Assessed by Investigator up to 24 Months After the Index Date
Time frame: up to 24 months after the index date
Secondary
OS Rate
Time frame: At 24 months after index date (baseline visit as reported in the eCRF)
Secondary
Percentage of Participants Receiving Later-line Therapy
Time frame: From index date up to Month 24
Secondary
Percentage of Participants With Therapy Modifications Due to Adverse Event Related to Avelumab Plus Axitinib Therapy
Time frame: From index date up to Month 24
Secondary
Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator
PFS2 was defined as time interval from the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The tumor response will be determined according to RECIST version 1.1 and assessed by the investigator. PFS2 was calculated based on Kaplan Meier method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
Time frame: From the index date to the date of disease progression on second-line treatment or death from any cause, whichever occurred first (assessed up to 12 months after index date)
Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Avelumab + Axitinib | Progression-free Survival 2 (PFS2) According to RECIST Version 1.1 Assessed by Investigator | NA months |
Secondary
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator
PFS time was defined as the time from index date to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST version 1.1, PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered PD. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. PFS was calculated based on KM method. The index date (baseline visit) was defined as the date of first administration after obtaining informed consent of avelumab plus axitinib therapy to participants with advanced RCC.
Time frame: From the index date to the date of disease progression or death from any cause, whichever occurred first (assessed up to 12 months after index date)
Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Avelumab + Axitinib | Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 Assessed by Investigator | 11.3 months |
Secondary
Time to Onset of All-cause AEs
Time frame: From index date up to Month 24
Secondary
Time to Second-line Therapy Initiation
Time to 2nd line treatment was calculated as: (2nd line treatment start date - last dose of Avelumab plus Axitinib + 1)/30.4375.
Time frame: Time from Avelumab plus Axitinib therapy discontinuation to the initiation of second-line therapy, up to Month 12
Population: AS included all eligible participants who provided written informed consent and received 1 or 2 cycles of avelumab plus axitinib treatment as a first-line therapy prior to informed consent. Here overall number of participants analyzed signified participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Avelumab + Axitinib | Time to Second-line Therapy Initiation | 0.3 months | Standard Deviation 0.4 |
Secondary
Time to Therapy Discontinuation Due to AE Greater Than or Equal to (>=) Grade-3
Time frame: From index date up to Month 24