## Protocol Section
### Identification Module
**NCT ID:** NCT06421311

**Acronym:** URADJ

**Brief Title:** Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France

**Official Title:** Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France

#### Organization Study ID Info
**ID:** CA209-1416
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2028-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.

### Conditions Module

**Conditions:**

- Urothelial Carcinoma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: nivolumab

**Label:** Participants with muscle invasive urothelial carcinoma receiving nivolumab

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants with muscle invasive urothelial carcinoma receiving nivolumab

**Description:** According to approved product label (France)

**Name:** nivolumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Disease-free survival (DFS) of participants

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

#### Secondary Outcomes

**Measure:** Time to recurrence (TRR)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Distance metastases-free survival (DMFS)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

**Measure:** Non-urothelial tract recurrence free survival (NUTRFS)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

**Measure:** Locoregional disease free survival (LRFDS)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

**Measure:** Overall survival (OS)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

**Measure:** Disease specific survival (DSS)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

**Measure:** Second progression-free survival (PFS2)

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

**Measure:** Participant demographics

**Time Frame:** Baseline

**Measure:** Participant baseline clinical characteristics

**Time Frame:** Baseline

**Measure:** Participant history of other cancer(s

**Time Frame:** Baseline

**Measure:** Participant comorbidities pre-existing at the time of adjuvant therapy initiation

**Time Frame:** Index date

**Measure:** Participant renal function at treatment initiation

**Time Frame:** Day 1

**Measure:** Participant concomitant systemic treatment(s)

**Time Frame:** Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Diagnosis of muscle-invasive urothelial carcinoma diagnosis

**Time Frame:** Baseline

**Measure:** Systemic neoadjuvant treatment history

**Time Frame:** Baseline

**Measure:** Surgery for muscle-invasive urothelial carcinoma

**Time Frame:** Baseline

**Measure:** Participant history of previous urothelial carcinoma

**Time Frame:** Baseline

**Measure:** PD-L1 status testing results

**Time Frame:** Baseline

**Measure:** Participant muscle Invasive urothelial carcinoma disease characteristics

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Time from initial diagnosis of muscle invasive disease to adjuvant treatment initiation

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Delay in adjuvant nivolumab treatment initiation related to post-operative complications

**Time Frame:** Baseline

**Measure:** Time from radical surgery to adjuvant nivolumab treatment initiation

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Adjuvant nivolumab treatment duration

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Number of adjuvant nivolumab treatment cycles

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Dose adjuvant nivolumab per cycle

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Reason for adjuvant nivolumab treatment interruption

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Reason for adjuvant nivolumab treatment discontinuation

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Non-systemic treatments prescribed post adjuvant nivolumab discontinuation

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Systemic treatment prescribed post adjuvant nivolumab discontinuation

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Measure:** Participant adverse events

**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

**Description:** Prospective participants only

**Measure:** Participant reported outcomes as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

**Time Frame:** Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression ≥ 1%:

  * Who received neoadjuvant chemotherapy OR
  * Who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy
* At least 18 years of age at the time of treatment decision
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively)

Exclusion Criteria:

* Participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled. Patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities).
* Pregnant women
* Participants under guardianship

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain NCT # and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Strasbourg

**Country:** France

**Facility:** ICANS Institut de Cancérologie Strasbourg Europe

**Zip:** 67200

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** FDA Safety Alerts and Recalls

**URL:** https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

## 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

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1854

- Name: Nivolumab

- Relevance: HIGH

- As Found: Prospective

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077594

- Term: Nivolumab

### Misc Info Module

- Version Holder: 2024-05-31
