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Antibody-drug conjugate
Enfortumab Vedotin for Advanced Cancer
Phase 2
Recruiting
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
ECOG performance status of 0 or 1
Subject has ECOG performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is effective and safe.
Who is the study for?
Adults with various advanced or metastatic cancers (like breast, lung, gastric, and head & neck cancer) who have measurable disease and are in good physical condition (ECOG 0-1). They must have normal organ function tests, no recent second malignancies or severe neuropathy, not be on active infection treatment, and without HIV or hepatitis B/C. Prior treatments should be completed at least 2 weeks before the trial.Check my eligibility
What is being tested?
The study is testing enfortumab vedotin's effectiveness against tumors by looking at response rates and overall survival. For one group (cohort 9), they're also adding pembrolizumab to see if it improves outcomes. Participants will be monitored for how well their tumors respond to these drugs as well as for safety and tolerability.See study design
What are the potential side effects?
Enfortumab vedotin may cause side effects like fatigue, hair loss, nausea, rash or blood sugar changes due to its action on cancer cells. Pembrolizumab can lead to immune-related issues such as inflammation of organs but might also cause tiredness or skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is hormone receptor positive and HER2 negative.
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My kidney function, measured by creatinine clearance or GFR, is adequate.
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I have available tumor tissue samples from my cancer.
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My cancer cannot be cured with surgery or radiation.
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My breast cancer is triple negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 9: Confirmed Overall Response Rate (ORR) (Complete Response (CR) and Partial Response (PR)) per RECIST V1.1 per investigator assessment
Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response (CR) and Partial Response(PR)) per RECIST V1.1 per investigator assessment
Secondary outcome measures
Cohort 9: Disease Control Rate (DCR) per RECIST V1.1 as per investigator assessment
Cohort 9: Duration of Overall Survival (OS)
Cohort 9: Duration of Progression Free Survival (PFS) per RECIST V1.1 as per investigator assessment
+15 moreTrial Design
9Treatment groups
Experimental Treatment
Group I: Cohort 9: Head and neck squamous cell carcinoma (HNSCC)Experimental Treatment2 Interventions
Participants will receive enfortumab vedotin as an IV infusion on days 1 and 8 of each 21-day cycle. Pembrolizumab will be administered as an IV infusion on day 1 of each 21-day cycle.
Group II: Cohort 8: Esophageal squamous cell carcinoma (ESCC)Experimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Group III: Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinomaExperimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Group IV: Cohort 6: Gastric or GEJ or esophageal cancerExperimental Treatment1 Intervention
Participants enrolled into Cohort 6 will be reallocated based on disease type and histology into Cohorts 7 or 8.
GEJ= gastroesophageal junction
Group V: Cohort 5: Head and neck cancerExperimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Group VI: Cohort 4: Non-squamous non-small cell lung cancerExperimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Group VII: Cohort 3: Squamous non-small cell lung cancerExperimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Group VIII: Cohort 2: Triple negative breast cancer (TNBC)Experimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Group IX: Cohort 1: HR+/HER2- breast cancerExperimental Treatment1 Intervention
Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
HR+/HER2- = Hormone receptor-positive/ human epidermal growth factor receptor 2-negative
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
enfortumab vedotin
2014
Completed Phase 1
~220
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,737 Total Patients Enrolled
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,742 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
68,837 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active hepatitis B or C.I am legally an adult and can sign the consent form.I am fully active or can carry out light work.My diabetes has been under control for the last 3 months.You have a medical condition that can be measured using the RECIST Version 1.1 criteria.Your blood tests were taken at the start of the study. If you had a blood transfusion recently, the tests must be taken at least 28 days after the transfusion.Your blood test shows normal levels of bilirubin, or slightly elevated levels if you have Gilbert's disease.I haven't had cancer treatments like chemotherapy or immunotherapy in the last 2 weeks.I have been treated with enfortumab vedotin or similar drugs before.Your body must have a certain amount of infection-fighting white blood cells called neutrophils, which should be at least 1.0 billion per liter.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with HIV.I am currently on medication for an infection.I can provide tumor samples from previous surgeries or I am willing to undergo a biopsy.My cancer is in the stomach, GEJ, or esophagus.I have an active eye infection or corneal ulcer.My lung cancer is non-squamous non-small cell type.I have head and neck cancer.I am allergic to enfortumab vedotin or similar drugs.My breast cancer is hormone receptor positive and HER2 negative.There are additional requirements specific to the group you are being considered for.My kidney function, measured by creatinine clearance or GFR, is adequate.I have had a stroke, heart attack, or severe heart symptoms in the last 6 months.I have not had major surgery in the last 4 weeks.I am experiencing notable side effects from previous treatments.I have available tumor tissue samples from my cancer.Your hemoglobin levels are at least 9 grams per deciliter.I am legally considered an adult where I live.You must use additional birth control methods, regardless of gender.My cancer cannot be cured with surgery or radiation.I have moderate to severe nerve damage affecting my senses or movement.I have not been diagnosed with another cancer or have any remaining cancer from a past diagnosis in the last 3 years.Your platelet count needs to be at least 100 billion per liter.My breast cancer is triple negative.My cancer has spread to my brain.You have a medical condition that makes you unable to participate in the study.My condition is squamous non-small cell lung cancer.You have a medical condition that is being studied in this clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinoma
- Group 2: Cohort 1: HR+/HER2- breast cancer
- Group 3: Cohort 3: Squamous non-small cell lung cancer
- Group 4: Cohort 5: Head and neck cancer
- Group 5: Cohort 8: Esophageal squamous cell carcinoma (ESCC)
- Group 6: Cohort 9: Head and neck squamous cell carcinoma (HNSCC)
- Group 7: Cohort 2: Triple negative breast cancer (TNBC)
- Group 8: Cohort 4: Non-squamous non-small cell lung cancer
- Group 9: Cohort 6: Gastric or GEJ or esophageal cancer
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.
Does enfortumab vedotin have official clearance from the FDA?
"The safety rating of enfortumab vedotin was assessed to be a 2, as this is a Phase 2 trial with preliminary data backing its security but no evidence confirming efficacy."
Answered by AI
What indications is enfortumab vedotin typically prescribed for?
"Enfortumab vedotin has been identified as a potential therapeutic option for metastatic urothelial cancer and pharmacotherapy."
Answered by AI
Have any further investigations utilized enfortumab vedotin as part of their research?
"The inaugural investigation into enfortumab vedotin was in 2014 at US00019. To date, there are two completed studies and 18 trials actively recruiting participants predominantly around Fort Myers, Florida."
Answered by AI
How many patients can be accepted into this research endeavor?
"Unfortunately, this trial is not accepting candidates at present. It was first posted on March 9th 2020 and the last edit occurred November 24th 2022. If you are seeking alternative sources of research opportunities, there are currently 2380 clinical trails recruiting patients with locally advanced or metastatic malignant solid tumors as well 18 trials for enfortumab vedotin actively enrolling participants."
Answered by AI
Is the enrollment period of this trial still open?
"Unfortunately, this specific medical trial is no longer actively recruiting. It was initially posted on March 9th of 2020 and underwent its last modification on November 24th of 2022. Although it has now closed, there are 2380 studies related to advanced or metastatic malignant solid tumors that remain open for enrollment as well as 18 trials concerning enfortumab vedotin in need of participants."
Answered by AI
Is this endeavor a pioneering venture?
"Presently, there are 18 active enfortumab vedotin trials taking place across 377 cities and 44 countries. Seagen Inc. first tested the medication in a Phase 1 clinical trial back in 2014 which included 213 participants; it was then followed by two additional studies since that time."
Answered by AI
Who else is applying?
What site did they apply to?
Florida Cancer Specialists
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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