Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Avelumab

Axitinib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients with metastatic renal cell carcinoma

avelumab

axitinib

Pfizer CT.gov Call Center

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.

Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)

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

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.

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'.

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).

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'.

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.

In this outcome measure, participants were categorized as "Yes" or "No" according to presence of sarcomatoid component were reported.

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.

In this outcome measure participants were reported according to number of metastatic organs as a) 1 and, b) 2 or more.

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.

In this outcome measure participants were reported as "Yes" or "No" according to presence of complications.

In this outcome measure, participants who underwent nephrectomy previously, were reported as "Yes' or "No".

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).

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.

CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay.

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".

In this outcome measure, participants who took concomitant drugs were reported.

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.

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.

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.

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.

In this outcome measure, number of participants who discontinued and had interruption of avelumab and axitinib treatment were reported.

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.

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.

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.

In this outcome measure, participants who had dose modification (increase/decrease) were reported.

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.

Immune-related adverse events (irAEs) was defined as the serious side effect of immune checkpoint inhibitor therapy for participants with advanced cancer.

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.

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.

In this outcome measure, number of participants who received any treatment for infusion-related reaction of avelumab were reported.

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.

Pfizer

This observational retrospective study retrieved data from medical records and the data existed as unstructured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence safety data were not collected and reported.

Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).

Avelumab + Axitinib as First-line Therapy

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

Pfizer ClinicalTrials.gov Call Center

Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS)

Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score

Number of Participants Categorized According to Fuhrman Grade

Number of Participants Categorized According to Histological Type

Number of Participants Categorized According to Presence of Sarcomatoid Component

Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification

Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Number of Participants Categorized According to Number of Metastatic Organs

Lung metastases

Liver metastases

Bone metastases

Brain metastases

Regional lymph node metastasis

Distant nodal metastasis

Number of Participants Categorized According to Type of Site of Metastases

Number of Participants According to Presence of Complications

Number of Participants Who Underwent Nephrectomy Previously

Estimated Glomerular Filtration Rate (eGFR)

Number of Participants With Proteinuria

C-reactive Protein (CRP)

Number of Participants Categorized According to Smoking Status

Number of Participants Who Took Concomitant Drugs

Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy

Real-world Progression Free Survival (PFS)

Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point.

Percentage of Participants With Objective Response

TTF: Avelumab

TTF: Axitinib

Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment

Avelumab: Discontinued

Avelumab: Interruption

Axitinib: Discontinued

Axitinib: Interruption

Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment

Disease progression

Adverse event

Sufficient efficacy

Others

Number of Participants With Reason for Discontinuation of Avelumab Treatment

Number of Participants With Reason for Discontinuation of Axitinib Treatment

Number of Participants With Reason for Interruption of Avelumab Treatment

Number of Participants With Reason for Interruption of Axitinib Treatment

Number of Participants With Dose Modification of Axitinib Treatment

Number of Participants According to Reason for Dose Modification of Axitinib Treatment

Prednisolone

Methylprednisolone sodium succinate

Hydrocortisone sodium succinate

Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment

Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment

Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment

Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab

Acetaminophen

Chlorpheniramine maleate

Diphenhydramine hydrochloride

Famotidine

Diclofenac sodium

Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab

Number of Participants Who Received Treatment for Infusion-related Reaction of Avelumab

TKI: Pazopanib

TKI: Cabozantinib

IO: Nivolumab

Others: Axitinib + Pembrolizumab

Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib

Overall Study

Medical Responsible

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 17 October 2022. 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.

Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

A Multicenter, NI, Retrospective, Observational Study Evaluating Real-World Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma (mRCC) Treated With Avelumab Plus Axitinib as First-line Therapy: J-DART2

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

TTD is defined as the time from the start of treatment with avelumab plus axitinib to the end of treatment due to any cause except the effectiveness of the treatment.

Real-world PFS, defined as time from start of avelumab/axitinib treatment to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, which ever 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 patients undertaking two or more lines of therapy based on the record, or at their last visit date during the study period for the patients undertaking only one line of therapy based on the record.

OS is defined as the time from the start of treatment with avelumab plus axitinib to the date of death due to any cause. If there are no clinical records of death, the date when the patient was last documented to be alive will be confirmed based on medical records. The data will be censored at the date of last contact.

The ORR is defined as the proportion of patients with a documented BOR (complete response (CR) or partial response (PR)) by the invesetigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows:

Complete or PR as the best adjudication result (CR \> PR \> stable disease \[SD\] \> progressive disease \[PD\], not Evaluable\[NE\]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.

The BOR is defined as the best tumor response recorded during the observation period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)	NCT05012865	Renal Cell Carc...	avelumab axitinib	20 Years -	Pfizer
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)	NCT05650164	Renal Cell Carc...	avelumab axitinib	18 Years -	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)	NCT05650164	Renal Cell Carc...	avelumab axitinib	18 Years -	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)	NCT05650164	Renal Cell Carc...	avelumab axitinib	18 Years -	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Spots Global Cancer Trial Database for metastatic renal cell cancer(mrcc)