Urothelial CarcinomaNCT06412848
JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study
An observational study of Urothelial Carcinoma, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 26 sites in Japan.
Trial summary
This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- Avelumab
- How many people
- 360 participants
- Where
- 26 sitesJapan
- Study dates
- 9 May 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Participants with locally advanced/metastatic Urothelial Carcinoma
Who may be able to join
- Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy
- Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab
- Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site
- Participants aged >= 18 years old at index date
- Other protocol defined inclusion criteria could apply
Who cannot join
- Participant participated in a clinical trial in la/m UC during the study periods.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Japan26 sites
Akita University Hospital
Akita, 010-0041
Juntendo University Hospital
Bunkyō City, Tokya, 113-0033
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kyushu Cancer Center
Fukuoka, 811-1347
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563
Nara Medical University Hospital
Kashihara, Nara, 634-8522
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Kumamoto University Hospital
Kumamoto, 860-8556
Kurume University Hospital
Kurume, Fukuoka, 830-0011
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kyoto University Hospital
Kyoto, 606-8507
Osaka International Cancer Institute
Osaka, 540-0008
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0374
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8648
Kindai University Hospital
Sayama, Osaka, 589-8511
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695
Teikyo University Hospital
tabashi City, Tokyo, 173-8606
Tokushima University Hospital
Tokushima, 770-0042
Ehime University Hospital
Tōon, Ehime, 791-0295
Toyama University Hospital
Toyama, 930-0194
Yamagata University Hospital
Yamagata, 9902331
About this study
Official title: A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.
- Conditions
- Urothelial Carcinoma
- Being tested
- Avelumab
- Keywords
- Urothelial Carcinoma, Avelumab, JAVEMACS, Locally advanced UC, Metastatic UC
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.
| Study group | Role | What they receive |
|---|---|---|
| Urothelial Carcinoma Cohort | This is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT). Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline clinical and demographic characteristics
To describe the baseline clinical and demographic characteristics of participants.
Measured: Baseline
Characteristics of the first line PBCT just prior to avelumab maintenance
Measured: Up to 3 months
Secondary outcomes (5)
Overall Survival (OS)
Measured: Up to 3 months
Progression-Free Survival (PFS)
Measured: Up to 3 months
Time to Treatment Failure (TTF)
Measured: Up to 3 months
Time to Next Treatment (TTNT)
Measured: Up to 3 months
Objective Response Rate (ORR)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start9 May 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial 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
- 360 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
- NCT06412848
- Sponsor's protocol ID
- MS100070_0209
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.
Publications
Endo Y, Kitamura H, Shirotake S, Ikeda M, Yonemori K, Kawamura N, Fujihara A, Abe T, Shimizu F, Fujimoto K, Nakagawa T, Hatakeyama S, Nishihara K, Ikarashi D, Masumori N, Naito S, Fujita K, Hara T, Miura N, Negishi T, Yatsuda J, Kobayashi M, Taoka R, Furukawa J, Shono M, Kobayashi T, Kikuchi E. Avelumab maintenance therapy for advanced urothelial carcinoma: subgroup analyses by characteristics of first-line platinum-based chemotherapy from a real-world chart review study in Japan (JAVEMACS). BMC Cancer. 2026 Mar 26;26(1):575. doi: 10.1186/s12885-026-15781-1.
PubMed 41888732
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06412848
- Acronym / sponsor ID
- MS100070_0209
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Carcinoma, Avelumab, JAVEMACS, Locally advanced UC, Metastatic UC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
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 locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urothelial Carcinoma Cohort | – | Drug: AvelumabThis is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with locally advanced/metastatic Urothelial Carcinoma
Key inclusion criteria (5 listed)
- Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy
- Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab
- Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site
- Participants aged >= 18 years old at index date
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (1 listed)
- Participant participated in a clinical trial in la/m UC during the study periods.
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 |
|---|---|---|
| AvelumabThis is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT. | Drug | Urothelial Carcinoma Cohort |
Primary outcome
Baseline clinical and demographic characteristics
Time frame: Baseline
To describe the baseline clinical and demographic characteristics of participants.
Characteristics of the first line PBCT just prior to avelumab maintenance
Time frame: Up to 3 months
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 months
Progression-Free Survival (PFS)
Time frame: Up to 3 months
Time to Treatment Failure (TTF)
Time frame: Up to 3 months
Time to Next Treatment (TTNT)
Time frame: Up to 3 months
Objective Response Rate (ORR)
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 41888732Endo Y, Kitamura H, Shirotake S, Ikeda M, Yonemori K, Kawamura N, Fujihara A, Abe T, Shimizu F, Fujimoto K, Nakagawa T, Hatakeyama S, Nishihara K, Ikarashi D, Masumori N, Naito S, Fujita K, Hara T, Miura N, Negishi T, Yatsuda J, Kobayashi M, Taoka R, Furukawa J, Shono M, Kobayashi T, Kikuchi E. Avelumab maintenance therapy for advanced urothelial carcinoma: subgroup analyses by characteristics of first-line platinum-based chemotherapy from a real-world chart review study in Japan (JAVEMACS). BMC Cancer. 2026 Mar 26;26(1):575. doi: 10.1186/s12885-026-15781-1.
- 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. IPD will not be shared for Phase I interventional or observational studies. 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
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 26 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 5 inclusion and 1 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Baseline clinical and demographic characteristics (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412848, which also lists 1 linked publication.
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 11 Aug 2026.