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Phase Ib trial of Erdafitinib combined with Enfortumab Vedotin following platinum and PD1/L1 inhibitors for metastatic urothelial carcinoma with FGFR2/3 genetic alterations

Clinical Trial Details

This study is evaluating what the safest and most tolerable dose of enfortumab vedotin that can be taken in combination with the standard dose of erdafitinib for metastatic urothelial carcinoma. This study aims to find out if this approach is better or worse than the usual approach for metastatic bladder cancer. The usual approach is defined as care most people get for metastatic bladder cancer.

Enfortumab vedotin is approved by the U.S. Food and Drug Administration (FDA) and erdafitinib is approved by the FDA for patients with mutations in the FGFR 2/3 gene.

Participants will receive enfortumab vedotin and erdafitinib in combination for up to 2 years. Each cycle of treatment lasts 28 days. Erdafitinib will be taken orally daily and brought in with the participant on Days 15 and 17 of Cycle 1 and Day 1 of Cycle 2. The participant will receive enfortumab vedotin through a vein in the arm over 30 minutes on Days 1, 8, and 15 of each cycle. 

Participants will also undergo testing during study visits, including eye exams, blood collection, physical exams, imagining, pregnancy tests, and at the end of the study an Electrocardiogram (ECG).

Total study participation will last for up to 2 years. Follow-up will last for up to two years and occur with clinical visits every 3 months for 2 years. 

Key Eligibility: 
  1. Open to men and women above the age of 18 who have been diagnosed with locally advanced or metastatic urothelial carcinoma.
  2. Participants must not have had chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks prior to entering the study

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)


646-962-2072
guonc@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2501028382

ClinicalTrials.gov:

NCT04963153

Sponsor:

10483

Status

Not Yet Recruiting

Age Group

Adult

Sponsor