Renal Cell CarcinomaNCT05012865
Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)
An observational study of Renal Cell Carcinoma, run by Pfizer at 12 sites in Japan.
Trial summary
This study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- avelumab and axitinib
- How many people
- 48 participants
- Where
- 12 sitesJapan
- Study dates
- 14 Sep 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020
Who may be able to join
- Diagnosed with metastatic renal cell cancer(mRCC) based on the General Rule for Clinical and Pathological Studies on Renal Cell Carcinoma (4th Edition) before receiving avelumab plus axitinib as a first-line therapy.
- Over 20 years of age at the time of metastatic renal cell cancer(mRCC) diagnosis.
- Start treatment with avelumab plus axitinib as a first-line therapy for metastatic renal cell cancer(mRCC) from 20 December 2019 to 20 December 2020.
- For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained.
- Deceased patients are also included for inclusion criteria 1-3.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Hiroshima University Hospital
Hiroshima, 734-8551
Iwamizawa Municipal General Hospital
Iwamizawa, Hokkaido, 068-8555
University Hospital,Kyoto Prefectural University of Medicine
Kamigyō-ku, Kyoto, 602-8566
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Osaka City University Hospital
Osaka, 545-8586
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550
Jichi Medical University Saitama Medical Center
Saitama, Saitama, 330-8503
Kindai University Hospital
Sayama, Osaka, 589-8511
Osaka University Hospital
Suita, Osaka, 565-0871
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, 569-8686
About this study
Official title: Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma Treated With Avelumab Plus Axitinib as a First-line Therapy
This study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.
- Conditions
- Renal Cell Carcinoma
- Being tested
- avelumab, axitinib
- Keywords
- Retrospective, Multicenter, Non-interventional, Medical chart review, Japan, Metastatic renal cell cancer(mRCC), Avelumab, Axitinib, First-line therapy, Standard care in real-world clinical setting
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avelumabDrug
as provided in real world practice
axitinibDrug
as provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic renal cell carcinoma | Patients with metastatic renal cell carcinoma Receives: Drug: avelumab; Drug: axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Participants whose score was not known were reported against "Unknown'.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score
IMDC criteria had 6 risk factors: Karnofsky Performance Status less than (<) 80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <1 year; corrected serum calcium; neutrophils and platelets more than (>) upper limit of normal (ULN); hemoglobin <lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (more than or equal to [>=]3 factors).
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Fuhrman Grade
The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. Participants whose Fuhrman Grade were not known were reported against "Unknown'.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Histological Type
In this outcome measure participants were reported according to the different histological type of mRCC including clear renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma and others.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Presence of Sarcomatoid Component
In this outcome measure, participants were categorized as "Yes" or "No" according to presence of sarcomatoid component were reported.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification
TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor <=20 millimeters (mm), T2: tumor >20 mm to <=50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Number of Metastatic Organs
In this outcome measure participants were reported according to number of metastatic organs as a) 1 and, b) 2 or more.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Type of Site of Metastases
Sites of metastases included: metastases of lung, liver, bone, brain, regional lymph nodes, distant nodal metastases and others. One participant could have more than 1 type of metastases.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants According to Presence of Complications
In this outcome measure participants were reported as "Yes" or "No" according to presence of complications.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Who Underwent Nephrectomy Previously
In this outcome measure, participants who underwent nephrectomy previously, were reported as "Yes' or "No".
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Estimated Glomerular Filtration Rate (eGFR)
GFR is an index of kidney function that describes the flow of filtered fluid through the kidney. eGFR was reported in millimeter per minute per 1.73 square meter (ml/min/1.73 m^2).
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Proteinuria
Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Here, negative = <15 milligrams per deciliter (mg/dL), positive=15-29 mg/dL, 1 = 30 mg/dL, 2= 100 mg/dL, 3= 300 mg/dL.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
C-reactive Protein (CRP)
CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Smoking Status
In this outcome measure, participants with smoking history were reported as No (No smoking history, never smoked), No (Smoking history exists, quit smoking), Yes (currently smoking). Participant whose smoking status was not known were reported against "Unknown".
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Who Took Concomitant Drugs
In this outcome measure, participants who took concomitant drugs were reported.
Measured: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Secondary outcomes (18)
Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy
TTF was defined as the time from the date of first dose of avelumab plus axitinib as first line therapy to the end of treatment for any cause earlier, including death. Kaplan-Meier method was used for analysis.
Measured: From index date up to 20-June-2021, where index date was date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020 (maximum observation period was of 1.5 years approximately).
Real-world Progression Free Survival (PFS)
PFS was defined as time from start of avelumab/axitinib treatment to date of first disease progression (DP) (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever came first. If there were no clinical records of death or disease progression, they were censored at the date of initiation of the next line of therapy for the participants undertaking 2 or more lines of therapy based on the record, or at their last visit date during the study period for the participants undertaking only 1 line of therapy based on the record.
Measured: From avelumab plus axitinib initiation to disease progression or death due to any cause/censored date (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approx 1.6 years]); retrieved data was analyzed during 4.5 months of this OS
Percentage of Participants With Objective Response
Objective response was defined as percentage of participants with complete response (CR) or partial response (PR) as the best adjudication result in a method complied with RECIST version. 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgment. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to <10 mm. PR: at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: From avelumab plus axitinib initiation to CR or PR (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study
Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment
TTF was defined as the time from the date of first dose of avelumab plus axitinib to the end of treatment for any cause earlier, including death. Kaplan-Meier method was used for analysis.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment
In this outcome measure, number of participants who discontinued and had interruption of avelumab and axitinib treatment were reported.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Discontinuation of Avelumab Treatment
In this outcome measure, participant who discontinued the avelumab treatment due to reasons including disease progression, adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for discontinuation of treatment.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Discontinuation of Axitinib Treatment
In this outcome measure, participant who discontinued the axitinib treatment due to reasons including disease progression, adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for discontinuation of treatment.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Interruption of Avelumab Treatment
In this outcome measure, participant who had treatment interruption due to reasons including adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for interruption of treatment.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Interruption of Axitinib Treatment
In this outcome measure, participant who had treatment interruption due to reasons including adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for interruption of treatment.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Dose Modification of Axitinib Treatment
In this outcome measure, participants who had dose modification (increase/decrease) were reported.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants According to Reason for Dose Modification of Axitinib Treatment
In this outcome measure, number of participants were reported against the reasons for dose modification of axitinib treatment. One participant could have more than 1 reason for modification of axitinib treatment.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment
Immune-related adverse events (irAEs) was defined as the serious side effect of immune checkpoint inhibitor therapy for participants with advanced cancer.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab
In this outcome measure, number of participants who were on pre-medication and presence of these medications were reason for potential infusion-related reaction of avelumab, were reported.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab
In this outcome measure, number of participants who were on pre-medication and presence of these medications were reason for potential infusion-related reaction of avelumab, were reported according to type of pre-medications. One participant could have taken more than 1 type of pre-medication.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Who Received Treatment for Infusion-related Reaction of Avelumab
In this outcome measure, number of participants who received any treatment for infusion-related reaction of avelumab were reported.
Measured: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib
In this outcome measure, number of participants who received subsequent treatment after avelumab plus axitinib therapy, were reported according to type of subsequent treatment including tyrosine kinase inhibitors (TKI), immuno-oncology (IO) drugs and others. Categories with at least 1 non-zero data are reported below.
Measured: From avelumab plus axitinib end of treatment to end of study observation (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start14 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012865
- Sponsor's protocol ID
- B9991043
- Status last verified
- Nov 2023
- First submitted
- 26 Jul 2021
- Last updated
- 6 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma Treated With Avelumab Plus Axitinib as a First-line Therapy
- ClinicalTrials.gov ID
- NCT05012865
- Acronym / sponsor ID
- B9991043
- Conditions
- Renal Cell Carcinoma
- Keywords
- Retrospective, Multicenter, Non-interventional, Medical chart review, Japan, Metastatic renal cell cancer(mRCC), Avelumab, Axitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic renal cell carcinoma | – | Drug: avelumab, Drug: axitinibPatients with metastatic renal cell carcinoma |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020
Key inclusion criteria (5 listed)
- Diagnosed with metastatic renal cell cancer(mRCC) based on the General Rule for Clinical and Pathological Studies on Renal Cell Carcinoma (4th Edition) before receiving avelumab plus axitinib as a first-line therapy.
- Over 20 years of age at the time of metastatic renal cell cancer(mRCC) diagnosis.
- Start treatment with avelumab plus axitinib as a first-line therapy for metastatic renal cell cancer(mRCC) from 20 December 2019 to 20 December 2020.
- For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained.
- Deceased patients are also included for inclusion criteria 1-3.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avelumabas provided in real world practice | Drug | Patients with metastatic renal cell carcinoma |
| axitinibas provided in real world practice | Drug | Patients with metastatic renal cell carcinoma |
Primary outcome
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Participants whose score was not known were reported against "Unknown'.
Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
IMDC criteria had 6 risk factors: Karnofsky Performance Status less than (<) 80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <1 year; corrected serum calcium; neutrophils and platelets more than (>) upper limit of normal (ULN); hemoglobin <lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (more than or equal to [>=]3 factors).
Number of Participants Categorized According to Fuhrman Grade
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. Participants whose Fuhrman Grade were not known were reported against "Unknown'.
Number of Participants Categorized According to Histological Type
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure participants were reported according to the different histological type of mRCC including clear renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma and others.
Number of Participants Categorized According to Presence of Sarcomatoid Component
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure, participants were categorized as "Yes" or "No" according to presence of sarcomatoid component were reported.
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor <=20 millimeters (mm), T2: tumor >20 mm to <=50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.
Number of Participants Categorized According to Number of Metastatic Organs
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure participants were reported according to number of metastatic organs as a) 1 and, b) 2 or more.
Number of Participants Categorized According to Type of Site of Metastases
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Sites of metastases included: metastases of lung, liver, bone, brain, regional lymph nodes, distant nodal metastases and others. One participant could have more than 1 type of metastases.
Number of Participants According to Presence of Complications
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure participants were reported as "Yes" or "No" according to presence of complications.
Number of Participants Who Underwent Nephrectomy Previously
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure, participants who underwent nephrectomy previously, were reported as "Yes' or "No".
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
GFR is an index of kidney function that describes the flow of filtered fluid through the kidney. eGFR was reported in millimeter per minute per 1.73 square meter (ml/min/1.73 m^2).
Number of Participants With Proteinuria
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Here, negative = <15 milligrams per deciliter (mg/dL), positive=15-29 mg/dL, 1 = 30 mg/dL, 2= 100 mg/dL, 3= 300 mg/dL.
C-reactive Protein (CRP)
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay.
Number of Participants Categorized According to Smoking Status
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure, participants with smoking history were reported as No (No smoking history, never smoked), No (Smoking history exists, quit smoking), Yes (currently smoking). Participant whose smoking status was not known were reported against "Unknown".
Number of Participants Who Took Concomitant Drugs
Time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
In this outcome measure, participants who took concomitant drugs were reported.
18 secondary outcomes
Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy
Time frame: From index date up to 20-June-2021, where index date was date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020 (maximum observation period was of 1.5 years approximately).
Real-world Progression Free Survival (PFS)
Time frame: From avelumab plus axitinib initiation to disease progression or death due to any cause/censored date (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approx 1.6 years]); retrieved data was analyzed during 4.5 months of this OS
Percentage of Participants With Objective Response
Time frame: From avelumab plus axitinib initiation to CR or PR (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study
Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Discontinuation of Avelumab Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Discontinuation of Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Interruption of Avelumab Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Reason for Interruption of Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Dose Modification of Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants According to Reason for Dose Modification of Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants Who Received Treatment for Infusion-related Reaction of Avelumab
Time frame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib
Time frame: From avelumab plus axitinib end of treatment to end of study observation (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Pfizer at 12 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) (time frame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.