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

NCT05650164 | Completed Results

• 2 other identifiers: B9991052J-DART2
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 19

Brief Summary

This study is a multicenter, non-interventional, retrospective, medical chart review of participants 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.

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 (26)

• Age of Participants at Baseline

  The age of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Height of Participants at Baseline

  The height of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Body Weight of Participants at Baseline

  The body weight of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Body Mass Index of Participants at Baseline

  The body mass index (BMI) of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• C-Reactive Protein Levels of Participants at Baseline

  The C-reactive protein levels of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Estimated Glomerular Filtration Rate of Participants at Baseline

  The estimated Glomerular Filtration Rate (eGFR) is an index of kidney function. eGFR was calculated using factors such as serum creatinine level, age, sex, and in millimeter per minute per 1.73 square meter (ml/min/1.73 m\^2), and tabulated in three categories (\<60, ≥60, unknown). An eGFR \<60 indicates some degree of kidney impairment. And eGFR \> 60 is generally considered to be within the normal range.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Smoking History Status of Participants at Baseline

  The smoking history status of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Eastern Cooperative Oncology Group (ECOG) Performance Scale Score Status of Participants at Baseline

  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.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Metastatic Organs at Baseline

  The Number of participants with Metastatic Organs of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Invasion Depth (T Factor) of Participants at Baseline

  TX: Primary tumor cannot be assessed, T0: No evidence of primary tumor, T1: Tumor ≤7 cm in greatest dimension, limited to the kidney, T1a: Tumor≤4cm in greatest dimension, limited to the kidney, T1b: Tumor\>4 cm but ≤7 cm in greatest dimension, limited to the kidney, T2: Tumor \>7 cm in greatest dimension, limited to the kidney, T2a: Tumor \>7 cm but ≤10 cm in greatest dimension, limited to the kidney, T2b: Tumor \>10 cm, limited to the kidney, T3: Tumor extends into major veins or perinephric tissues, but not into the ipsilateral adrenal gland and not beyond Gerota's fascia,T3a: Tumor extends into the renal vein or its segmental branches, or invades the pelvicalyceal system, or invades perirenal and, T3b: Tumor extends into the vena cava below the diaphragm, T3c: Tumor extends into the vena cava above the diaphragm or invades the wall of the vena cava, T4: Tumor invades beyond Gerota's fascia (including contiguous extension into the ipsilateral adrenal gland)

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Lymph Node Metastasis (N Factor) Status of Participants at Baseline

  Lymph node metastasis (N factor) of participants at baseline was reported. NX: Regional lymph nodes cannot be assessed, N0: No regional lymph node metastasis, N1: Metastasis in regional lymph node(s).

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Distant Metastasis (M Factor) Status of Participants at Baseline

  Distant metastasis (M factor) of participants at baseline was reported. M0: No distant metastasis, M1: Distant metastasis.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Tumor Histological Type of Participants at Baseline

  Tumor histological type of participants at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Presence or Absence of Sarcomatoid Component in Participants at Baseline

  Number of Participants with Presence or Absence of Sarcomatoid Component at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Fuhrman Grade Status of Participants at Baseline

  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'.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Availability of Proteinuria in Participants at Baseline

  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) (Normal), positive (±) =15-29 mg/dL (increased risk for kidney disease), (1+) = 30 mg/dL(Early stages of kidney disease), (2+)= 100 mg/dL (Underlying kidney disease), (3+)= 300 mg/dL (kidney dysfunction).

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Performance of Nephrectomy in Participants

  Performance of nephrectomy at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Presence or Absence of Clinically Important Comorbidities of Participants at Baseline

  Number of Participants with Presence or absence of clinically important comorbidities at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Presence or Absence of Clinically Important Concomitant Drugs in Participants at Baseline

  Number of participants with Presence or absence of clinically important concomitant drugs at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Initiation of Systemic Therapy Within One Year of Diagnosis

  Number of Participants with Initiation of Systemic Therapy within One Year of Diagnosis was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Karnofsky Performance Status Less Than (<) 80 Percent (%) at Baseline

  Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Hemoglobin Value Below the Lower Normal Limit at Baseline

  Number of participants with Hemoglobin value below the lower normal limit at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Corrected Calcium Value Above the Upper Normal Limit in Participants at Baseline

  Number of participants with Corrected calcium value above the upper normal limit at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Participants With Neutrophil Count Above the Upper Normal Limit in Participants at Baseline

  Number of Participants with Neutrophil count above the upper normal limit at baseline was reported.

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• International Metastatic RCC Database Consortium (IMDC) Risk Group in Participants at Baseline

  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: Low risk (0 factor), Medium risk (1-2 factors), High risk (more than or equal to \[\>=\]3 factors).

  At Baseline (prior to initial treatment with avelumab plus axitinib)

• Number of Risk Factors in Participants at Baseline

  Number of risk factors in participants at baseline was reported

  At Baseline (prior to initial treatment with avelumab plus axitinib)

Secondary Outcomes (5)

• Real-World Progression-Free Survival (Rw-PFS)

  From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)

• Time to Treatment Discontinuation (TTD)

  From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)

• Overall Survival (OS)

  From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)

• Percentage of Participants With Best Overall Response of CR or PR (Objective Response Rate)

  From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)

• Number of Participants With Best Overall Response (BOR) for Primary Lesions

  From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)

Study Arms (1)

Participants with metastatic renal cell carcinoma

Participants with metastatic renal cell carcinoma

Drug: avelumab; Drug: axitinib

Interventions

avelumab DRUG

as provided in real world practice

Participants with metastatic renal cell carcinoma

axitinib DRUG

as provided in real world practice

Participants with metastatic renal cell carcinoma

Eligibility Criteria

• Age: 18 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 17 October 2022

You may qualify if:

• Diagnoses of mRCC based on the General Rule for Clinical and Pathological Studies on RCC (Fifth Edition) before receiving avelumab plus axitinib as first-line therapy. Patients with mRCC who have unresectable disease, either unresectable locally advanced or metastatic disease.
• Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline).
• Index date from 20 December 2019 to 17 October 2022.

You may not qualify if:

• Patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period.
• Patients (or a patient's legally representative) refusing to provide patient data during the consent process.

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (19)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Hirosaki University Hospital

Hirosaki, Aomori, 036-8563, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, 078-8510, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kochi Medical School Hospital

Nankoku, Kochi, 783-8505, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, Kyoto, 612-8555, Japan

Location

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Jichi Medical University Saitama Medical Center

Saitama, Saitama, 330-8503, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

Location

Yamagata University Hospital

Yamagata, Yamagata, 990-9585, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

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: Communication Center
• Organization: Merck Healthcare KGaA, DarmstadtGermany, an affiliate of Merck KGaA,Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 25, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (19)