Clinical Trials/NCT05012865

NCT05012865

Completed

Not Applicable

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

Pfizer12 sites in 1 country48 target enrollmentSeptember 14, 2021

ConditionsRenal Cell Carcinoma

Interventionsaxitinib avelumab

Overview

Phase: Not Applicable
Intervention: axitinib
Conditions: Renal Cell Carcinoma
Sponsor: Pfizer
Enrollment: 48
Locations: 12
Primary Endpoint: Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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. 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.

Registry

clinicaltrials.gov

Start Date

September 14, 2021

End Date

January 31, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•There are no exclusion criteria for this study.

Arms & Interventions

Patients with metastatic renal cell carcinoma

Intervention: axitinib

Patients with metastatic renal cell carcinoma

Intervention: avelumab

Outcomes

Primary Outcomes

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 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.

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).

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.

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.

Number of Participants According to Presence of Complications

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

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'.

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'.

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.

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.

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.

Number of Participants Who Underwent Nephrectomy Previously

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

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.

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".

Number of Participants Who Took Concomitant Drugs

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

Secondary Outcomes

Number of Participants With Reason for Interruption of Axitinib Treatment(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(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)
Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy(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).)
Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment(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(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 Axitinib Treatment(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(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(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)
Real-world Progression Free Survival (PFS)(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(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)
Number of Participants With Dose Modification of Axitinib Treatment(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 Avelumab Treatment(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(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(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(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(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(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(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)