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Antibody-Drug Conjugate
Enfortumab Vedotin for Bladder Cancer (EV-103 Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment
Cohort B: Must have disease progression during/following treatment with at least 1 platinum-containing regimen for la/mUC or disease recurrence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
EV-103 Trial Summary
This trial will test an experimental drug, enfortumab vedotin, either alone or in combination with other cancer treatments. Pembrolizumab is a checkpoint inhibitor that is used to treat patients with urothelial cancer--a type of cancer that includes bladder, renal pelvis, ureter, or urethra cancer. The study will examine the side effects of enfortumab vedotin and measure if the cancer shrinks with different treatment combinations.
Who is the study for?
This trial is for adults with advanced or muscle-invasive urothelial cancer, including bladder and other urinary cancers. Participants should be eligible for certain chemotherapy drugs like cisplatin or carboplatin, and some may also qualify for pembrolizumab treatment. They must not have received specific prior treatments, have a good performance status (able to carry out daily activities), and an expected lifespan of at least 3 months.Check my eligibility
What is being tested?
The study tests enfortumab vedotin alone or combined with anticancer therapies such as pembrolizumab, cisplatin, carboplatin, and gemcitabine. It aims to see if these treatments can shrink the cancer in patients with locally advanced or metastatic urothelial cancer as well as those with muscle-invasive bladder cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug entering the body, fatigue, digestive issues like nausea or diarrhea, blood disorders that affect cell counts and increase infection risk.
EV-103 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can't have cisplatin and haven't been treated for advanced bladder cancer, or my cancer got worse after platinum treatment.
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My cancer got worse or came back after treatment with a platinum-based drug.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My bladder cancer diagnosis was confirmed through tissue examination.
Select...
I cannot receive cisplatin as a treatment.
EV-103 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)
Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)
Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
+1 moreSecondary outcome measures
Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only)
Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Confirmed ORR by investigator assessment per the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
+29 moreEV-103 Trial Design
12Treatment groups
Experimental Treatment
Group I: Randomized Cohort K: Enfortumab Vedotin MonotherapyExperimental Treatment1 Intervention
Enfortumab vedotin on days 1 and 8 every 21 days
Group II: Randomized Cohort K: Enfortumab Vedotin + PembrolizumabExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group III: Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant settingExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group IV: Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2LExperimental Treatment2 Interventions
Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days
Group V: Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group VI: EV + Pembrolizumab in cisplatin-ineligible 1L and in 2LExperimental Treatment2 Interventions
Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Group VII: Cohort L: Enfortumab vedotin in MIBC in perioperative settingExperimental Treatment1 Intervention
Enfortumab vedotin on days 1 and 8 and every 21 days
Group VIII: Cohort H: Enfortumab vedotin in MIBC neoadjuvant settingExperimental Treatment1 Intervention
Enfortumab vedotin on days 1 and 8 every 21 days
Group IX: Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1LExperimental Treatment4 Interventions
Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days
Group X: Cohort E: Enfortumab Vedotin + Carboplatin in 1LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days
Group XI: Cohort D: Enfortumab Vedotin + Cisplatin in 1LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days
Group XII: Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1LExperimental Treatment2 Interventions
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
cisplatin
1997
Completed Phase 3
~3290
carboplatin
2010
Completed Phase 3
~4790
gemcitabine
2013
Completed Phase 3
~3530
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
194 Previous Clinical Trials
121,028 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,370 Total Patients Enrolled
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
73,800 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received PD-1, PD-L1, or PD-L2 inhibitors, except if I'm in Cohort F.If you are in Cohort J, H, or L, you have not received certain types of treatments for MIBC, but may have had specific bladder treatments in the past. If you are in Cohort J, you may be eligible for pembrolizumab.I have not taken drugs like CD137 agonists, OX-40 agonists, or CTLA-4 inhibitors for my cancer, except if I'm in Cohort F.I have had prior treatment with a checkpoint inhibitor.I have bladder cancer with evidence of nodal disease.I have ongoing nerve issues in my senses or movements that are moderate to severe.I am eligible for pembrolizumab treatment.I am not on high doses of steroids or other drugs that weaken my immune system.I have been treated with enfortumab vedotin or similar drugs before.You are expected to live for at least 3 more months.I can care for myself, but my daily activities might be limited. My blood count and kidney function are within required levels, and I don't have severe heart failure.My cancer got worse or came back after treatment with a platinum-based drug.I can't have platinum-based chemo but can take gemcitabine for my urinary cancer.I am experiencing significant side effects from previous cancer treatments.I have had treatments like immunotherapy for my bladder cancer.I am on high doses of steroids or other drugs that weaken my immune system.My bladder cancer is mostly urothelial and has not spread beyond nearby lymph nodes.My tumor sample from a recent bladder surgery is available for review.I have had treatment with enfortumab vedotin or similar drugs for bladder cancer.I had another type of cancer within the last 3 years.I am eligible for cisplatin chemotherapy and haven't had platinum-based treatment in the last year.I can't have cisplatin but can have carboplatin, and haven't had treatments for my bladder cancer or platinum-based therapy in the last year.I can't have cisplatin due to kidney issues, hearing loss, heart failure, or my physical condition.I have had surgery to remove part of my bladder for cancer.I can't have cisplatin and haven't been treated for advanced bladder cancer, or my cancer got worse after platinum treatment.I am eligible for platinum-based chemotherapy and haven't had it or any similar treatment in the last year.I have had treatment for muscle invasive bladder cancer before.My cancer is advanced or has spread and is in the urinary system.I can take care of myself and am up and about more than half of my waking hours.My cancer has spread to my brain or spinal cord.My bladder cancer diagnosis was confirmed through tissue examination.I cannot receive cisplatin as a treatment.My diabetes is not under control.I have muscle invasive bladder cancer.I can't have cisplatin-based chemotherapy and haven't been treated for locally advanced/metastatic urothelial cancer.I have ongoing nerve issues in my senses or movements that are moderate to severe.I am considered a candidate for bladder removal surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort L: Enfortumab vedotin in MIBC in perioperative setting
- Group 2: Randomized Cohort K: Enfortumab Vedotin Monotherapy
- Group 3: Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting
- Group 4: Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting
- Group 5: Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
- Group 6: Cohort D: Enfortumab Vedotin + Cisplatin in 1L
- Group 7: Cohort E: Enfortumab Vedotin + Carboplatin in 1L
- Group 8: Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
- Group 9: Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
- Group 10: EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
- Group 11: Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
- Group 12: Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
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 types of cancer does enfortumab vedotin (EV) commonly target?
"EV has shown to be an effective treatment against lymphoma and non-hodgkin. Additionally, it can also help treat other conditions such as malignant melanoma of skin, recurrent cervical cancer, refractory, relapsed mediastinal large b-cell lymphoma."
Answered by AI
What goals does this experiment hope to realize?
"The primary purpose of this trial, which will be conducted over a period of approximately 3 years, is to evaluate the confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Secondary outcomes include Pathologic downstaging (pDS) rate by central pathology review (MIBC cohorts only), PK parameter for MMAE: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only), and DOR by BICR according to RECIST 1."
Answered by AI
Are participants being accepted into the trial at this time?
"That is accurate. The listing on clinicaltrials.gov affirms that this trial, which was originally published on October 11th 2017, is still recruiting patients. 467 people are needed for the study and it is being hosted at 88 different facilities."
Answered by AI
What other treatments has EV been tested against in the past?
"EV was first studied in 1997 and there are now 2449 completed studies. 2270 trials are still active, with several of them based in Milwaukee, Wisconsin."
Answered by AI
At how many different sites is this trial being conducted?
"So far, 88 patients have enrolled at locations like the Medical College of Wisconsin (Milwaukee), the Medical University of South carolina/Hollings Cancer Center in Charleston, and Weill Cornell Medical College in New york. There are also 88 other sites where people can enroll."
Answered by AI
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