Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

Conditions

• Advanced Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enfortumab Vedotin — DRUG
  Given by IV
• Radiation Therapy — RADIATION
  Given by Radiation Therapy

Study Details

To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.

Key Dates

Start date

Oct 10, 2024

Status verified

Feb 2026

Primary completion

Sep 24, 2027

Completion

Sep 24, 2027

Study Design

Enrollment

41 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Enfortumab Vedotin with Radiation
  Particpants will receive enfortumab vedotin by vein over about 1-2 hours on Days 1 and 8 of every 28-day cycle. Two dose levels of enfortumab vedotin will be tested. The dose of enfortumab vedotin participants receive will depend on when the participant join the study. Participants will also receive radiation therapy 5 times a week (Monday through Friday) for about 4-5 weeks.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

• Comron Hassanzadeh, MD
  (713) 657-9802
  [email protected]

Locations (1)

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