Enfortumab Vedotin for Adenoid Cystic Carcinoma

Recruiting at 7 trial locations

Overseen By David Pfister, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Brain metastasis, Prior malignancy, 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: 3

Duration: 12 months

34 Participants Needed

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 determine its safety and effectiveness in treating adenoid cystic carcinoma (ACC), a cancer that can occur in various parts of the body, including the salivary glands. Participants will receive the treatment through an IV on a specific schedule. Suitable candidates have confirmed ACC that has recurred or spread and have exhausted other curative treatment options. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

The trial requires that at least 4 weeks have passed since your last systemic treatment before starting the study drug. This suggests you may need to stop certain medications, but the protocol does not specify all details about other medications you might be taking.

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

Research has shown that enfortumab vedotin has undergone safety testing, yielding promising results. Almost all patients in the studies experienced side effects, but most were mild to moderate, indicating that the treatment is generally manageable. Although some risks exist, the side effects are not severe for most individuals. The treatment's approval for other conditions further supports its safety for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Enfortumab Vedotin is unique because it targets cancer cells differently than standard treatments for adenoid cystic carcinoma, which typically include surgery, radiation, and chemotherapy. Unlike these traditional options, Enfortumab Vedotin is an antibody-drug conjugate that specifically seeks out and attaches to cancer cells, delivering a potent chemotherapy agent directly to them. This targeted approach not only aims to increase the effectiveness of the treatment but also potentially reduces the side effects associated with traditional chemotherapy, as it spares more of the healthy cells. Researchers are excited about this treatment because it represents a new way of tackling the disease, potentially offering better outcomes for patients with fewer side effects.

What evidence suggests that enfortumab vedotin might be an effective treatment for adenoid cystic carcinoma?

Research has shown that enfortumab vedotin has helped 44% of patients with advanced bladder cancer, a different type of cancer. This finding suggests it might also benefit those with adenoid cystic carcinoma (ACC), which sometimes shares a similar biological marker called Nectin-4. Approximately 30.7% of ACC cases have Nectin-4, the target of enfortumab vedotin. Participants in this trial will receive enfortumab vedotin to assess its effectiveness specifically in ACC. Although this treatment appears promising, its effectiveness in ACC is still under investigation. Early results in other cancers are encouraging, but further research is needed to confirm its impact on ACC. ^{1 2 3 6 7}

Who Is on the Research Team?

Alan Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This clinical trial is for individuals with adenoid cystic carcinoma, a type of cancer that can occur in various parts of the body. Participants should have this specific diagnosis to be eligible.

Inclusion Criteria

I have or can provide tumor tissue samples for study.

Participants must be willing to sign the written informed consent form

Screening laboratory values must meet specific criteria including Neutrophils, Platelets, Hemoglobin, AST, ALT, Total Bilirubin, Serum creatinine, and Creatinine clearance

Exclusion Criteria

I have brain metastasis that has not been treated.

I haven't had cancer treatment in the last 4 weeks.

I haven't had serious heart issues like heart failure, unstable angina, heart attack, or dangerous arrhythmias in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with enfortumab vedotin intravenously on Days 1, 8, and 15 of a 28-day cycle

12 months

3 visits per 28-day cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enfortumab Vedotin

Trial Overview The study is testing enfortumab vedotin's effectiveness and safety as a treatment option for those suffering from adenoid cystic carcinoma.

How Is the Trial Designed?

Group I: Enfortumab Vedotin Experimental Treatment 1 Intervention

Participants are treated with enfortumab vedotin at the FDA-approved dose and schedule of intravenously on Days 1, 8 and 15 of a 28-day cycle.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Astellas Pharma US, Inc.

Industry Sponsor

Trials

90

Recruited

12,900+

Naoki Okamura

Astellas Pharma US, Inc.

Chief Executive Officer since 2023

Not available

Tadaaki Taniguchi

Astellas Pharma US, Inc.

Chief Medical Officer since 2023

MD, PhD

Published Research Related to This Trial

Enfortumab vedotin, an antibody drug conjugate for advanced urothelial carcinoma, can cause extravasation leading to serious skin reactions like bullae and cellulitis, as seen in two reported cases.

Both patients successfully managed their cellulitis conservatively and resumed treatment without further complications, suggesting that with proper management, the risks associated with extravasation can be mitigated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug extravasation with Enfortumab vedotin. Grant, CR., de Kouchkovsky, D., Kalebasty, AR., et al.[2023]

Enfortumab vedotin showed a 44% overall response rate in a phase II trial involving 125 patients with locally advanced or metastatic urothelial carcinoma who had previously undergone platinum-based chemotherapy and PD-1 or PD-L1 checkpoint inhibitor treatment.

While nearly all patients experienced treatment-related adverse events, most of these side effects were mild to moderate, indicating a manageable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enfortumab Vedotin Checks Urothelial Cancer. [2020]

Enfortumab vedotin, a treatment for advanced bladder cancer, can cause severe skin reactions, with a case report highlighting a patient who developed toxic epidermal necrolysis shortly after starting the drug.

The case emphasizes the need for careful monitoring of skin reactions and suggests that if such reactions occur, treatment may need to be reduced or stopped to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxic epidermal necrolysis after the administration of enfortumab vedotin for urinary bladder urothelial carcinoma. Mimura, Y., Kobayashi, A., Utazu, H., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06891560

NCT06891560 | A Study of Enfortumab Vedotin in People ... The purpose of this study is to find out whether enfortumab vedotin is an effective and safe treatment for people with adenoid cystic carcinoma (ACC).

2. withpower.com withpower.com/trial/phase-2-carcinoma-2-2025-ffca8

Enfortumab Vedotin for Adenoid Cystic Carcinoma Enfortumab vedotin showed a 44% overall response rate in a phase II trial involving 125 patients with locally advanced or metastatic urothelial carcinoma who ...

3. mskcc.org mskcc.org/cancer-care/clinical-trials/24-215

A Phase 2 Study of Enfortumab Vedotin in People With ... Researchers want to see how well enfortumab vedotin works in people with adenoid cystic carcinoma. This cancer most often starts in the salivary glands.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10495532/

Nectin-4 is frequently expressed in primary salivary gland ... A moderate or high Nectin-4 expression was found in 25.9% of salivary duct carcinomas (SaDu) and in 30.7% of adenoid cystic carcinomas (ACC).

5. urotoday.com urotoday.com/ev-302-te/videos/4560-real-world-effectiveness-of-enfortumab-vedotin-in-advanced-urothelial-carcinoma-umang-swami.html

Real-World Effectiveness of Enfortumab Vedotin in ... Real-world data from these 371 patients indicated median overall survival ranging from 7.2 to 11 months, and EV remained effective irrespective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11372787/

Post-marketing drug safety surveillance of enfortumab ... Unfortunately, the cause of death could not be determined by the FAERS data, which may due to the disease progression of cancer or other factors ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0039494

Adenoid Cystic Carcinoma (DBCOND0039494) Associated Data ; NCT04140526. Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC. Docetaxel ...