## Protocol Section
### Identification Module
**NCT ID:** NCT06412848

**Brief Title:** JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

**Official Title:** A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

#### Organization Study ID Info
**ID:** MS100070_0209
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Drug:** True

### Description Module

**Brief 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. 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 Module

**Conditions:**

- Urothelial Carcinoma

**Keywords:**

- Urothelial Carcinoma

- Avelumab

- JAVEMACS

- Locally advanced UC

- Metastatic UC

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Drug: Avelumab

**Label:** Urothelial Carcinoma Cohort

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Urothelial Carcinoma Cohort

**Description:** This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.

**Name:** Avelumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To describe the baseline clinical and demographic characteristics of participants.

**Measure:** Baseline clinical and demographic characteristics

**Time Frame:** Baseline

**Measure:** Characteristics of the first line PBCT just prior to avelumab maintenance

**Time Frame:** Up to 3 months

#### Secondary Outcomes

**Measure:** Overall Survival (OS)

**Time Frame:** Up to 3 months

**Measure:** Progression-Free Survival (PFS)

**Time Frame:** Up to 3 months

**Measure:** Time to Treatment Failure (TTF)

**Time Frame:** Up to 3 months

**Measure:** Time to Next Treatment (TTNT)

**Time Frame:** Up to 3 months

**Measure:** Objective Response Rate (ORR)

**Time Frame:** Up to 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* Participant participated in a clinical trial in la/m UC during the study periods.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Participants with locally advanced/metastatic Urothelial Carcinoma

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** service@emdgroup.com

**Name:** Communication Center

**Phone:** +49 6151 72 5200

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hirosaki

**Country:** Japan

**Facility:** Hirosaki University Hospital

**State:** Aomori

**Status:** NOT_YET_RECRUITING

**Zip:** 036-8563

**Location 2:**

**City:** Toon

**Country:** Japan

**Facility:** Ehime University Hospital

**State:** Ehime

**Status:** NOT_YET_RECRUITING

**Zip:** 791-0295

**Location 3:**

**City:** Kurume

**Country:** Japan

**Facility:** Kurume University Hospital

**State:** Fukuoka

**Status:** NOT_YET_RECRUITING

**Zip:** 830-0011

**Location 4:**

**City:** Sapporo

**Country:** Japan

**Facility:** Hokkaido University Hospital

**State:** Hokkaido

**Status:** NOT_YET_RECRUITING

**Zip:** 060-8648

**Location 5:**

**City:** Sapporo

**Country:** Japan

**Facility:** Sapporo Medical University Hospital

**State:** Hokkaido

**Status:** NOT_YET_RECRUITING

**Zip:** 060-8648

**Location 6:**

**City:** Kobe

**Country:** Japan

**Facility:** Kobe University Hospital

**State:** Hyogo

**Status:** RECRUITING

**Zip:** 650-0017

**Location 7:**

**City:** Shiwa-gun

**Country:** Japan

**Facility:** Iwate Medical University Hospital

**State:** Iwate

**Status:** NOT_YET_RECRUITING

**Zip:** 028-3695

**Location 8:**

**City:** Kita-gun

**Country:** Japan

**Facility:** Kagawa University Hospital

**State:** Kagawa

**Status:** RECRUITING

**Zip:** 761-0793

**Location 9:**

**City:** Kawasaki

**Country:** Japan

**Facility:** St. Marianna University Hospital

**State:** Kanagawa

**Status:** NOT_YET_RECRUITING

**Zip:** 216-8511

**Location 10:**

**City:** Sagamihara

**Country:** Japan

**Facility:** Kitasato University Hospital

**State:** Kanagawa

**Status:** NOT_YET_RECRUITING

**Zip:** 252-0374

**Location 11:**

**City:** Kashihara

**Country:** Japan

**Facility:** Nara Medical University Hospital

**State:** Nara

**Status:** RECRUITING

**Zip:** 634-8522

**Location 12:**

**City:** Osakasayama

**Country:** Japan

**Facility:** Kindai University Hospital

**State:** Osaka

**Status:** NOT_YET_RECRUITING

**Zip:** 589-8511

**Location 13:**

**City:** Hidaka

**Country:** Japan

**Facility:** Saitama Medical University International Medical Center

**State:** Saitama

**Status:** NOT_YET_RECRUITING

**Zip:** 350-1298

**Location 14:**

**City:** Bunkyo-ku

**Country:** Japan

**Facility:** Juntendo University Hospital

**State:** Tokya

**Status:** NOT_YET_RECRUITING

**Zip:** 113-0033

**Location 15:**

**City:** Bunkyo-ku

**Country:** Japan

**Facility:** Nippon Medical School Hospital

**State:** Tokyo

**Status:** NOT_YET_RECRUITING

**Zip:** 113-8603

**Location 16:**

**City:** Chuo-ku

**Country:** Japan

**Facility:** National Cancer Center Hospital

**State:** Tokyo

**Status:** NOT_YET_RECRUITING

**Zip:** 104-0045

**Location 17:**

**City:** Itabashi-ku

**Country:** Japan

**Facility:** Teikyo University Hospital

**State:** Tokyo

**Status:** NOT_YET_RECRUITING

**Zip:** 173-8606

**Location 18:**

**City:** Akita

**Country:** Japan

**Facility:** Akita University Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 010-0041

**Location 19:**

**City:** Fukuoka

**Country:** Japan

**Facility:** Kyushu Cancer Center

**Status:** RECRUITING

**Zip:** 811-1347

**Location 20:**

**City:** Kumamoto

**Country:** Japan

**Facility:** Kumamoto University Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 860-8556

**Location 21:**

**City:** Kyoto

**Country:** Japan

**Facility:** University Hospital Kyoto Prefectural University of Medicine

**Status:** NOT_YET_RECRUITING

**Zip:** 602-8566

**Location 22:**

**City:** Kyoto

**Country:** Japan

**Facility:** Kyoto University Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 606-8507

**Location 23:**

**City:** Osaka

**Country:** Japan

**Facility:** Osaka International Cancer Institute

**Status:** RECRUITING

**Zip:** 540-0008

**Location 24:**

**City:** Tokushima

**Country:** Japan

**Facility:** Tokushima University Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 770-0042

**Location 25:**

**City:** Toyama

**Country:** Japan

**Facility:** Toyama University Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 930-0194

**Location 26:**

**City:** Yamagata

**Country:** Japan

**Facility:** Yamagata University Hospital

**Status:** RECRUITING

**Zip:** 9902331

#### Overall Officials

**Official 1:**

**Affiliation:** Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

**Name:** Medical Responsible

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5551

- Name: Carcinoma, Transitional Cell

- Relevance: HIGH

- As Found: Urothelial Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T5693

- Name: Transitional Cell Carcinoma

- Relevance: HIGH

- As Found: Urothelial Carcinoma

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002295

- Term: Carcinoma, Transitional Cell

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M344580

- Name: Avelumab

- Relevance: HIGH

- As Found: Reach

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000609138

- Term: Avelumab

### Misc Info Module

- Version Holder: 2024-05-31
