Endometrial CancerPhase 2EV-4-ECNCT07139977
Study of EV for Recurrent Endometrial Carcinoma
A Phase 2 study testing Enfortumab Vedotin in people with Endometrial Cancer, run by William Bradley at 1 site in United States.
Trial summary
This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Enfortumab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to 31 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient of age ≥18 years.
- Recurrent and progressive endometrial cancer, all stages at primary diagnosis. The histology types will be pending the preclinical assessments, but can include:
- Endometrioid endometrial carcinoma
- Serous endometrial carcinoma
- Prior standard of care of surgical intervention, including hysterectomy.
- Evidence of disease progression on or following the most recent line of therapy prior to screening. Therapy must include platinum-based chemotherapy. If the patient is eligible for immunotherapy, this must have been provided. Patient may have received either radiation therapy or hormone therapy, neither of which will be considered a line of therapy. Chemotherapy during radiotherapy will not be considered a line of therapy.
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- Maximum of three prior lines of therapy. Neo-adjuvant and postsurgical therapy, if provided, will be counted as 1 line of therapy. Therapy given in a maintenance fashion after primary treatment will not be counted as a line of therapy.
- IHC expression of nectin-4.
- Toxicity from prior treatment recovered to G1 or G0.
- ECOG status of 1 or 0.
- At least 1 measurable target lesion according to RECIST v1.1, including the following criteria:
- Non-nodal lesion that measures ≥ 1.0 cm in the longest diameter.
- Lymph node (LN) lesion that measures as ≥ 1.5 cm in the short axis.
- The lesion is suitable for repeat measurement using computed tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of subsequent growth after treatment.
- Documented tumor status for MSI and MMR.
- In the opinion of the investigator, the patient must have a life expectancy of at least 12 weeks and be well enough to receive experimental therapy.
- Adequate organ function as determined by laboratory tests defined in the table below at screening.
- Hematological: Absolutely neutrophil count (ANC)≥ 1500/μL, Platelets ≥ 100,000/μL, Hemoglobin ≥ 9.0 g/dL or 5.6 mmol/L, No erythropoietin dependency or packed red blood cell transfusion within last 2 weeks.
- Renal: Creatinine, OR ≤ 1.5 x ULN, Creatinine clearance as calculated per institutional standard ≥ 30 mL/min for patients with creatinine > 1.5 × institutional ULN Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ≤ 3 ULN for participants with Gilbert's syndrome. AST, ALT ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastases
- Ability to understand a written informed consent document, and the willingness to sign it.
- Pregnancy: It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Nonsterilized female patients of reproductive age and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below. Female patients must meet one of the following:
- Postmenopausal for at least one year before the screening visit, or
- Surgically sterile, or
- If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of study drug, AND
- Must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, or
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.) Male patients/partners of patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:
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- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR
- Must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
Who cannot join
- Diagnosis of endometrial sarcoma (leiomyosarcoma, endometrial stromal sarcoma, high-grade sarcoma).
- Diagnosis of non-endometrioid and non-serous endometrial cancer. Mixed tumors involving histologic types other than serous and endometrioid will not be eligible.
- Tumor sample does not express nectin-4 (local IHC testing).
- Symptomatic CNS metastases or leptomeningeal metastases. Patients with symptomatic brain metastasis must be treated and must be stable for at least 4 weeks prior to study treatment.
- Active second malignancy with anti-cancer treatments (except for treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months.
- Sensory or motor neuropathy ≥ G2
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- Prior history of significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA)Class II, unstable angina, myocardial infarction, or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability.
- Active infection requiring systemic IV antibiotics within 14 days, or oral antibiotics within 7 days, prior to administration of study drugs. Regular treatment of urinary tract infection (UTI) and/or topical treatment are allowed.
- Uncontrolled diabetes defined as HgbA1c of ≥ 8%.
- Hepatitis B, C, or HIV infection.
- Have not recovered to CTCAE v5.0 Grade 0 or 1 (except chemotherapy related grade 2 peripheral neuropathy, or grade 2 endocrinopathy with adequate replacement therapy) from any toxicity and/or complications from major surgery or prior cancer therapeutics before starting therapy.
- Ongoing treatment for EC, including radiation therapy, hormonal therapy, chemotherapy, immunotherapy, or any investigational therapy, unless they have been discontinued at least 4 weeks prior to screening and there is no plan to re-initiate during the study. radiation therapy is allowed prior to and during study drug administration as long as there are no acute toxicities.
- Active intestinal obstruction.
- Known psychiatric or substance use disorders that would interfere with cooperation with the requirements of the trial.
- Any conditions that required systemic immunosuppression therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) within 7 days prior to the first dose of study drug.
- Pregnant or lactating patients.
- In the opinion of the Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or make study participation, not in the best interest of the patient. The Investigator should discuss with the Sponsor and/or study leaders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Sukanya Skandarajah, 4148055337, sskandarajah@mcw.edu
Subana Paul, 4148058594, supaul@mcw.edu
About this study
Official title: Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma
This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.
Read the detailed description
This is an open-label, single-arm Phase II trial evaluating the efficacy and safety of enfortumab vedotin monotherapy in up to 12 patients with advanced or metastatic endometrial carcinoma who have progressed after prior chemotherapy and anti-PD-1 or other immunotherapy. Treatment will continue for up to 12 months or until disease progression per RECIST v1.1, unacceptable toxicity, or patient withdrawal.
Patients with stable disease or objective response may remain on therapy unless discontinued due to toxicity or patient choice. Those who discontinue treatment for reasons other than progression will be followed for disease status until progression.
- Conditions
- Endometrial Cancer
- Being tested
- Enfortumab Vedotin
- Keywords
- endometrial cancer, endometrioid, serous endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab VedotinDrug
Enfortumab vedotin is an ADC comprised of a fully human IgG1Κ antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable linker. Enfortumab vedotin is thought to induce anti-tumor activity by binding to the nectin-4 protein on the surface of cancer cells, leading to internalization, proteolytic cleavage of the linker, and intracellular release of MMAE that subsequently disrupts tubulin polymerization and leads to mitotic arrest and apoptosis of the tumor cell.
| Study group | Role | What they receive |
|---|---|---|
| Enfortumab vedotin: 1.25 mg/kg on days 1,8, and 15 of the 28 day cycle | Experimental | Single arm trial Receives: Drug: Enfortumab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the overall response rate (ORR)
Overall response rate (ORR) of enfortumab vedotin treatment for patients with endometrioid or serous endometrial cancer, i.e., proportion of patients with a complete or partial response as per RECIST v1.1.
Measured: 24 months
Evaluate the safety of enfortumab vedotin treatment
Incidence of adverse events (AEs) and serious adverse event (SAEs) as defined by NCI CTCAE v5.
Measured: 24 months
Secondary outcomes (4)
Characterize the Duration of Response (DOR)
Duration of response (DOR), i.e., the time from date of initial response to therapy by RECIST v1.1 to subsequent disease progression, relapse or death.
Measured: 30 months
Estimate overall survival (OS)
Median overall survival (OS), i.e., the time from date of treatment to the date of death due to any reason.
Measured: 24 months
Estimate progression-free survival (PFS)
the time from date of treatment to the date of disease progression or death, as assessed per RECIST v1.1.
Measured: 12 months
Duration of response (DOR) by MMR status.
Subgroup analysis of response by MMR status (i.e., proficient or deficient), and by TCGA sub-type, 1. Ultramutated (POLE), 2. Hypermutated (MSI), 3. Copy Number low (endometrioid), 4. Copy-Number high (serous like).
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start10 Jul 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Bradley
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, William Bradley, Medical College of Wisconsin
- Investigators
- William Bradley, MD, Principal investigator, Medical College of Wiscnson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139977
- Sponsor's protocol ID
- PRO00055484
- Acronym
- EV-4-EC
- Status last verified
- May 2026
- First submitted
- 18 Aug 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-site, Investigator-Initiated Trial (IIT). There are no plans to share individual participant data beyond the study site.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT07139977
- Acronym / sponsor ID
- EV-4-EC / PRO00055484
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, endometrioid, serous endometrial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- William BradleyUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.
Detailed description
This is an open-label, single-arm Phase II trial evaluating the efficacy and safety of enfortumab vedotin monotherapy in up to 12 patients with advanced or metastatic endometrial carcinoma who have progressed after prior chemotherapy and anti-PD-1 or other immunotherapy. Treatment will continue for up to 12 months or until disease progression per RECIST v1.1, unacceptable toxicity, or patient withdrawal.
Patients with stable disease or objective response may remain on therapy unless discontinued due to toxicity or patient choice. Those who discontinue treatment for reasons other than progression will be followed for disease status until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enfortumab vedotin: 1.25 mg/kg on days 1,8, and 15 of the 28 day cycle | Experimental | Drug: Enfortumab VedotinSingle arm trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Female patient of age ≥18 years.
- Recurrent and progressive endometrial cancer, all stages at primary diagnosis. The histology types will be pending the preclinical assessments, but can include:
- Prior standard of care of surgical intervention, including hysterectomy.
- Evidence of disease progression on or following the most recent line of therapy prior to screening. Therapy must include platinum-based chemotherapy. If the patient is eligible for immunotherapy, this must have been provided. Patient may have received either radiation therapy or hormone therapy, neither of which will be considered a line of therapy. Chemotherapy during radiotherapy will not be considered a line of therapy.
- Maximum of three prior lines of therapy. Neo-adjuvant and postsurgical therapy, if provided, will be counted as 1 line of therapy. Therapy given in a maintenance fashion after primary treatment will not be counted as a line of therapy.
Key exclusion criteria (17 listed)
- Diagnosis of endometrial sarcoma (leiomyosarcoma, endometrial stromal sarcoma, high-grade sarcoma).
- Diagnosis of non-endometrioid and non-serous endometrial cancer. Mixed tumors involving histologic types other than serous and endometrioid will not be eligible.
- Tumor sample does not express nectin-4 (local IHC testing).
- Symptomatic CNS metastases or leptomeningeal metastases. Patients with symptomatic brain metastasis must be treated and must be stable for at least 4 weeks prior to study treatment.
- Active second malignancy with anti-cancer treatments (except for treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enfortumab VedotinEnfortumab vedotin is an ADC comprised of a fully human IgG1Κ antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable linker. Enfortumab vedotin is thought to induce anti-tumor activity by binding to the nectin-4 protein on the surface of cancer cells, leading to internalization, proteolytic cleavage of the linker, and intracellular release of MMAE that subsequently disrupts tubulin polymerization and leads to mitotic arrest and apoptosis of the tumor cell. | Drug | Enfortumab vedotin: 1.25 mg/kg on days 1,8, and 15 of the 28 day cycle |
Primary outcome
Estimate the overall response rate (ORR)
Time frame: 24 months
Overall response rate (ORR) of enfortumab vedotin treatment for patients with endometrioid or serous endometrial cancer, i.e., proportion of patients with a complete or partial response as per RECIST v1.1.
Evaluate the safety of enfortumab vedotin treatment
Time frame: 24 months
Incidence of adverse events (AEs) and serious adverse event (SAEs) as defined by NCI CTCAE v5.
4 secondary outcomes
Characterize the Duration of Response (DOR)
Time frame: 30 months
Estimate overall survival (OS)
Time frame: 24 months
Estimate progression-free survival (PFS)
Time frame: 12 months
Duration of response (DOR) by MMR status.
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. This is a single-site, Investigator-Initiated Trial (IIT). There are no plans to share individual participant data beyond the study site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Bradley, MD principal investigator
Medical College of Wiscnson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enfortumab Vedotin in people with Endometrial Cancer, run by William Bradley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mastaneh Irani (4148056621, mairani@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the overall response rate (ORR) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.