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

ConditionUrothelial Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iza-bren

    Drug

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

  • Gemcitabine

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

Treatment groups

470 Participants
are divided into 5 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BExperimental treatment 1 intervention
Group C: Arm CActive comparator 3 interventions
Group D: Arm DExperimental treatment 1 intervention
Group E: Arm EActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507

Time frame
Approximately 3 months
2

Phase 3: Progression-Free Survival (PFS)

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)

Time frame
Up to 5 years
3

Phase 3: Overall Survival (OS)

Time frame
Up to 5 years

Secondary outcomes

1

Phase 2: Objective Response (OR)

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator

Time frame
Up to 5 years
2

Phase 2: PFS

Assessed using RECIST v1.1 by investigator

Time frame
Up to 5 years
3

Phase 2: Duration of Response (DOR)

Assessed using RECIST v1.1 by investigator

Time frame
Up to 5 years
4

Phase 2: Time to Response (TTR)

Assessed using RECIST v1.1 by investigator

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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