Renal Cell CarcinomaNCT05650164
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)
An observational study of Renal Cell Carcinoma, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 19 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- avelumab and axitinib
- How many people
- 171 participants
- Where
- 19 sitesJapan
- Study dates
- 25 Jan 2023to 13 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Kyushu University Hospital
Fukuoka, 812-8582
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563
Hiroshima University Hospital
Hiroshima, 734-8551
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
National Hospital Organization Kyoto Medical Center
Kyoto, Kyoto, 612-8555
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Kochi Medical School Hospital
Nankoku, Kochi, 783-8505
Jichi Medical University Saitama Medical Center
Saitama, Saitama, 330-8503
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Kindai University Hospital
Sayama, Osaka, 589-8511
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Osaka University Hospital
Suita, Osaka, 565-0871
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
About this study
Official title: 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
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
- Being tested
- avelumab, axitinib
- 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
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avelumabDrug
as provided in real world practice
axitinibDrug
as provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Participants with metastatic renal cell carcinoma | Participants with metastatic renal cell carcinoma Receives: Drug: avelumab; Drug: axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age of Participants at Baseline
The age of participants at baseline was reported.
Measured: At Baseline (prior to initial treatment with avelumab plus axitinib)
Height of Participants at Baseline
The height of participants at baseline was reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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).
Measured: At Baseline (prior to initial treatment with avelumab plus axitinib)
Performance of Nephrectomy in Participants
Performance of nephrectomy at baseline was reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: At Baseline (prior to initial treatment with avelumab plus axitinib)
Secondary outcomes (5)
Real-World Progression-Free Survival (Rw-PFS)
rwPFS is defined as: The time from start of avelumab plus axitinib therapy 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, whichever occurred first.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
The ORR is defined as the proportion of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator 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.
Measured: 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
BOR is the best tumor response recorded during observation period.Tumor response are defined as follows:Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD],not Evaluable[NE]) in a method complied with RECIST version. 1.1tumor assessment as closely as possible in clinical practice by investigator's judgment.CR:Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR:Atleast 30% decrease in sum of diameters of target lesions,taking as reference the baseline sum diameters.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters. PD:atleast a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start25 Jan 2023
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650164
- Sponsor's protocol ID
- B9991052
- Other IDs
- J-DART2
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2022
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05650164
- Acronym / sponsor ID
- B9991052
- Conditions
- Renal Cell Carcinoma
- Keywords
- Retrospective, Multicenter, Non-interventional, Medical chart review, Japan, Metastatic renal cell cancer(mRCC), Avelumab, Axitinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with metastatic renal cell carcinoma | – | Drug: avelumab, Drug: axitinibParticipants with metastatic renal cell carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avelumabas provided in real world practice | Drug | Participants with metastatic renal cell carcinoma |
| axitinibas provided in real world practice | Drug | Participants with metastatic renal cell carcinoma |
Primary outcome
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.
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.
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.
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)
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).
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.
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 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.
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.
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
5 secondary outcomes
Real-World Progression-Free Survival (Rw-PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 19 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age of Participants at Baseline (time frame: At Baseline (prior to initial treatment with avelumab plus axitinib)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.