Enfortumab Vedotin for Endometrial Cancer

(EV-4-EC Trial)

Overseen By Sukanya Skandarajah, Research Operations Manager

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: William Bradley

Must not be taking: Immunosuppressants, Antibiotics

Disqualifiers: Endometrial sarcoma, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests enfortumab vedotin, an antibody-drug conjugate, to evaluate its effectiveness for women with advanced endometrial cancer that has progressed after other treatments, including immunotherapy. The trial aims to determine the drug's safety and effectiveness over up to one year. Women whose endometrial cancer has returned or worsened after previous treatments, such as surgery and chemotherapy, may qualify. Participants will receive the drug on a structured schedule and undergo close monitoring for response and health. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, ongoing treatment for endometrial cancer must be stopped at least 4 weeks before screening, and there should be no plan to restart it during the study.

Is there any evidence suggesting that enfortumab vedotin is likely to be safe for humans?

Research has shown that enfortumab vedotin has been tested in other cancers, such as bladder cancer, with most patients tolerating the treatment without severe side effects. One study tested enfortumab vedotin with another drug, KEYTRUDA, for varying durations, providing insights into its long-term safety.

When a treatment reaches a Phase 2 study, like enfortumab vedotin for endometrial cancer, it indicates existing evidence of safety from earlier studies. This phase focuses more on the treatment's effectiveness while still monitoring safety closely. It's important to remember that every treatment can have side effects, and these trials help identify what those might be and how often they occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometrial cancer?

Unlike the standard treatments for endometrial cancer, which often involve surgery, radiation, and chemotherapy, Enfortumab Vedotin offers a novel approach by targeting a specific protein found on cancer cells. This drug is an antibody-drug conjugate, meaning it combines an antibody with a cancer-killing agent to deliver treatment directly to cancer cells, potentially minimizing damage to healthy cells. Researchers are excited about Enfortumab Vedotin because it may provide a more targeted treatment option with fewer side effects, and it could be effective in cases where other treatments have failed.

What evidence suggests that enfortumab vedotin might be an effective treatment for endometrial cancer?

Research has shown that enfortumab vedotin, a type of targeted cancer treatment, holds potential for treating certain cancers. In earlier studies, it shrank or controlled cancer in 37.1% of patients with tumors expressing HER2, a specific protein. This drug delivers a cancer-fighting substance directly to cancer cells, helping to protect healthy cells. Although information on its effects on endometrial cancer remains limited, these early results are promising. Further research, including this single-arm trial, will help confirm these findings. ^{1 2 6 7 8}

Who Is on the Research Team?

William Bradley, MD

Principal Investigator

Medical College of Wiscnson

Are You a Good Fit for This Trial?

This trial is for up to 12 patients with advanced endometrial cancer that has progressed despite prior treatments, including immunotherapy. Participants will receive treatment for up to a year and be monitored over time.

Inclusion Criteria

At least 1 measurable target lesion according to RECIST v1.1

Ability to understand and sign a written informed consent document

My cancer's MSI/MMR status is documented.

Exclusion Criteria

I have had serious heart problems in the last year.

I have brain or spinal cord cancer symptoms.

I do not have severe nerve damage that affects my senses or movements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enfortumab vedotin monotherapy for up to 12 months or until disease progression, unacceptable toxicity, or patient withdrawal

12 months

Visits on days 1, 8, and 15 of each 28-day cycle

Follow-up

Participants are monitored for disease status and overall survival after treatment discontinuation

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Enfortumab Vedotin

Trial Overview

The study is examining the effectiveness and safety of a drug called enfortumab vedotin in individuals with recurrent endometrial carcinoma who have undergone previous therapies.

How Is the Trial Designed?

Group I: Enfortumab vedotin: 1.25 mg/kg on days 1,8, and 15 of the 28 day cycle Experimental Treatment 1 Intervention

Single arm trial

Who Is Running the Clinical Trial?

William Bradley

Lead Sponsor

Astellas Pharma Inc

Industry Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

Top Products

- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention

Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07139977

Study of EV for Recurrent 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 ...

2.

withpower.com

withpower.com/trial/phase-2-endometrial-neoplasms-10-2025-e4637

Enfortumab Vedotin for Endometrial Cancer (EV-4-EC Trial)

This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11898814/

Development of Antibody–Drug Conjugates for ...

Preliminary results from the ongoing phase I trial (NCT05263479) showed that 44 patients, including one with endometrial cancer, received HS-20089, with a ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1048891X25010989

Antibody-drug conjugates in gynecologic cancer

The trial demonstrated an objective response rate of 37.1% and durable responses in patients with HER2-expressing (immunohistochemistry [IHC] 3+ or IHC 2+) ...

5.

international-journal-of-gynecological-cancer.com

international-journal-of-gynecological-cancer.com/article/S1048-891X(25)00122-7/fulltext

The clinical landscape of antibody-drug conjugates in ...

Clinical outcomes remain challenging in advanced or recurrent endometrial cancer due to tumor heterogeneity and therapy resistance. Antibody-drug conjugates ...

6.

keytrudahcp.com

keytrudahcp.com/safety/adverse-reactions/urothelial-cancer-first-line-combination-therapy/

Safety Data and Adverse Reactions for KEYNOTE-A39

Among patients who received KEYTRUDA and enfortumab vedotin, the median duration of exposure to KEYTRUDA was 8.5 months (range: 9 days to 28.5 months). Fatal ...

7.

merck.com

merck.com/news/merck-advances-oncology-innovation-highlighting-progress-in-new-tumor-types-and-earlier-stages-of-disease-at-esmo-2025/

Merck Advances Oncology Innovation, Highlighting ...

EV-103 cohort K: Efficacy and safety of enfortumab vedotin (EV) with or without pembrolizumab (P) in cisplatin (cis)-ineligible pts with ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.19.01140

Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma ...

Enfortumab vedotin demonstrated a clinically meaningful response rate with a manageable and tolerable safety profile in patients with locally advanced or ...