Brief Title: Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507

Primary Outcome 1 - Timeframe: Approximately 3 months

Primary Outcome 2 - Measure: Phase 3: Progression-Free Survival (PFS)

Primary Outcome 2 - Timeframe: Up to 5 years

Primary Outcome 3 - Measure: Phase 3: Overall Survival (OS)

Primary Outcome 3 - Timeframe: Up to 5 years

CONDITION

• Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
* Participants must have histologically confirmed advanced urothelial carcinoma.

- * Participants must be eligible to receive platinum-based chemotherapy.

- * Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.

- * Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.

- * Participants must have ≥ 1 measurable lesion per RECIST v1.1.

- * Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion Criteria:
* Participants must not have platinum-based chemotherapy exposure within 12 months.

- * Participants must not have received >2 prior regimens irrespective of the setting.

- * Participants must not have prior ADC therapy targeting EGFR or HER3.

- * Participants must not have prior therapy with topoisomerase 1 inhibitor.

- * Participants must not have active, untreated brain metastases.

- * Other protocol-defined inclusion/exclusion criteria apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, First line of the email MUST contain NCT # and Site #.

Phone: 855-907-3286

Email: [email protected]

LOCATION