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

NCT05012865 | Completed Results

• 1 other identifier: B9991043
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 12

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.

Conditions

Renal Cell Carcinoma

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

Outcome Measures

Primary Outcomes (15)

• 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'.

  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).

  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'.

  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.

  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.

  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.

  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.

  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.

  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.

  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".

  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).

  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.

  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.

  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".

  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.

  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

  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)

  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

• 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

Study Arms (1)

Patients with metastatic renal cell carcinoma

Patients with metastatic renal cell carcinoma

Drug: avelumab; Drug: axitinib

Interventions

avelumab DRUG

as provided in real world practice

Patients with metastatic renal cell carcinoma

axitinib DRUG

as provided in real world practice

Patients with metastatic renal cell carcinoma

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Gunma Prefectural Cancer Center

Ōta, Gunma, 373-8550, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

Location

Iwamizawa Municipal General Hospital

Iwamizawa, Hokkaido, 068-8555, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

University Hospital,Kyoto Prefectural University of Medicine

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 569-8686, Japan

Location

Jichi Medical University Saitama Medical Center

Saitama, Saitama, 330-8503, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

avelumab; Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 19, 2021
• Study Start: September 14, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 6, 2023
• Results First Posted: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12)