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Antibody-Drug Conjugate
Enfortumab Vedotin + Pembrolizumab for Advanced Bladder Cancer
Phase 2
Recruiting
Led By Bassel Nazha, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented pure variant histology (nested, microcytic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell) bladder cancer and non-urothelial bladder cancer of epithelial origin including: pure squamous cell carcinoma and pure adenocarcinoma (urachal and non-urachal). Variant histology tumors and non-urothelial tumors of ureter, urethra, urachus, or renal pelvis are included. All histological classifications will follow the 2016 World Health Organization (WHO) classifications
Age >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests a targeted drug and immunotherapy to treat advanced bladder cancer of rare types.
Who is the study for?
Adults with advanced or metastatic bladder cancer of variant histology, who are fit (ECOG <=1), have not had recent treatments that could interfere, and can provide tumor samples. Women must not be pregnant and all participants must agree to use contraception. Exclusions include certain other cancers, uncontrolled illnesses, prior EV or PD-1/PD-L1 inhibitor treatment, active infections like hepatitis B/C, autoimmune diseases requiring systemic treatment within 2 years.Check my eligibility
What is being tested?
The trial is testing the combination of Enfortumab Vedotin (EV) and Pembrolizumab in treating less common types of bladder cancer that has spread. EV targets nectin-4 on cancer cells to deliver a drug that kills them; Pembrolizumab helps the immune system fight cancer.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, fatigue, nausea, skin rash from enfortumab vedotin; pembrolizumab might cause immune-related issues such as inflammation in organs like lungs or intestines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer is of a specific type, not the usual kind.
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I am 18 years old or older.
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I am mostly active and can care for myself.
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My cancer has spread or cannot be removed by surgery.
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I have either not been treated or have received multiple treatments.
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I can provide tumor samples or agree to a biopsy before starting the study.
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My cancer can be measured by scans according to specific criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (enfortumab vedotin, pembrolizumab)Experimental Treatment6 Interventions
Patients receive enfortumab vedotin IV and pembrolizumab IV on study. Patients also undergo CT scan or MRI, and collection of blood throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,980 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,203 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,671 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had serious heart problems like heart failure or unstable angina in the last 6 months.The doctor believes you will live for at least 12 more weeks.I have moderate to severe numbness, tingling, or muscle weakness.My bladder cancer is of a specific type, not the usual kind.I have diabetes with an HbA1c level of 7% or higher and symptoms like frequent urination or thirst.I am on antibiotics for an infection or taking high dose steroids.I finished all my cancer treatments at least 4 weeks ago.My cancer is not a sarcomatoid or neuroendocrine type.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any serious side effects.I haven't used any experimental drugs or devices in the last 21 days.You have had allergic reactions to similar drugs in the past.I am currently breastfeeding.I am either male or female.I am 18 years old or older.I am mostly active and can care for myself.My cancer has spread or cannot be removed by surgery.I am a woman capable of becoming pregnant.I have previously been treated with or enrolled in a study for EV or PD1/PD-L1 inhibitors.I do not have any uncontrolled illnesses that would stop me from following the study's requirements.I have either not been treated or have received multiple treatments.I can provide tumor samples or agree to a biopsy before starting the study.I am willing and able to follow the study's schedule and procedures.My cancer can be measured by scans according to specific criteria.I am not pregnant and have taken a test to confirm this before starting treatment.I have not needed treatment for an autoimmune disease, hepatitis B, hepatitis C, or tuberculosis in the last 2 years.You have had an eye condition called keratitis or corneal ulcers recently.I have received an organ or tissue transplant from another person.My bladder cancer is not the common type but one of the rare forms like sarcoma or melanoma.I have active cancer spread to my brain or spinal cord.I have no active cancer other than the one I'm enrolling for, except for certain treated skin, prostate, bladder, or cervical cancers.My organs and bone marrow are functioning well, as confirmed by recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enfortumab vedotin, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What perils are associated with the administration of enfortumab vedotin and pembrolizumab?
"Given the amount of safety data present in Phase 2 trials, Treatment (enfortumab vedotin, pembrolizumab) is rated a 2 on our team's 1-3 scale. In other words, there are some supportive findings regarding its security but none for efficacy."
Answered by AI
Are there any vacancies remaining for individuals in this trial?
"According to clinicaltrials.gov, this study is not currently enrolling patients; it was first launched on March 31st 2023 and has since been updated February 20th 2023. Despite this fact, there are 5,540 other active trials actively recruiting people at the moment."
Answered by AI
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