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Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

ConditionsBladder Squamous Cell CarcinomaLocally Advanced Bladder CarcinomaMalignant Renal Pelvis NeoplasmMalignant Ureter NeoplasmMalignant Urethral NeoplasmMetastatic Bladder CarcinomaStage III Bladder Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Unresectable Bladder CarcinomaUrachal AdenocarcinomaBladder Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or Female

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Metastatic disease or unresectable locally advanced disease

Disqualifiers

The neuroendocrine histology (small cell and large cell carcinomas) and non-epithelial bladder tumors (e.g. bladder sarcoma, carcinosarcoma, paraganglioma, melanoma, primary lymphoma, and lymphoepithelioma-like carcinoma) are excluded.

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier [i.e. ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment]

Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Enfortumab Vedotin

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Pembrolizumab

    Biological/Vaccine

    Given IV

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (enfortumab vedotin, pembrolizumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall response rate

Will be measured by Response Evaluation Criteria in Solid Tumors version 1.1, and estimated by the Clopper-Pearson method with 95% confidence intervals.

Time frame
Up to 2 years

Secondary outcomes

1

Progression free survival

Kalan-Meier method will be used to estimate median event time and 2-year survival rate with 95% confidence interval.

Time frame
From treatment initiation until disease progression or death due to any cause, assessed up to 2 years
2

Overall survival

Kalan-Meier method will be used to estimate median event time and 2-year survival rate with 95% confidence interval.

Time frame
From treatment initiation until death due to any cause, assessed up to 2 years
3

Duration of response

Determined by occurrence of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.

Time frame
From response initiation to progression or death, whichever occurs first, assessed up to 2 years
4

Incidence of adverse events

Graded according to the Common Terminology Criteria for Adverse Events version 5.0, and will be tabulated using descriptive statistics (mean, median, minimum, maximum, standard deviation).

Time frame
Assessed up to 2 years

Other outcomes

Sponsors and contacts

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

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Seagen Inc.

Collaborator

Astellas Pharma Inc

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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