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Clinical Trials/NCT05650164
NCT05650164
Completed
Not Applicable

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

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany19 sites in 1 country171 target enrollmentJanuary 25, 2023

Overview

Phase
Not Applicable
Intervention
avelumab
Conditions
Renal Cell Carcinoma
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Enrollment
171
Locations
19
Primary Endpoint
Age of Participants at Baseline
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2023
End Date
October 13, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Participants with metastatic renal cell carcinoma

Participants with metastatic renal cell carcinoma

Intervention: avelumab

Participants with metastatic renal cell carcinoma

Participants with metastatic renal cell carcinoma

Intervention: axitinib

Outcomes

Primary Outcomes

Age of Participants at Baseline

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

The age of participants at baseline was reported.

Height of Participants at Baseline

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

The height of participants at baseline was reported.

Body Weight of Participants at Baseline

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

The body weight of participants at baseline was reported.

Body Mass Index of Participants at Baseline

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

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

C-Reactive Protein Levels of Participants at Baseline

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

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

Estimated Glomerular Filtration Rate of Participants at Baseline

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

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.

Smoking History Status of Participants at Baseline

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

The smoking history status of participants at baseline was reported.

Number of Participants With Metastatic Organs at Baseline

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

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

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

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

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).

Tumor Histological Type of Participants at Baseline

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

Tumor histological type of participants at baseline was reported.

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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.

Invasion Depth (T Factor) of Participants at Baseline

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

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)

Distant Metastasis (M Factor) Status of Participants at Baseline

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

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

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

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

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

Fuhrman Grade Status of Participants at Baseline

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

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'.

Availability of Proteinuria in Participants at Baseline

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

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).

Performance of Nephrectomy in Participants

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

Performance of nephrectomy at baseline was reported.

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

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

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).

Number of Risk Factors in Participants at Baseline

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

Number of risk factors in participants at baseline was reported

Secondary Outcomes

  • 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 Sites (19)

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