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A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

Phase II Trial of Enfortumab Vedotin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma

NCT06891560•Memorial Sloan Kettering Cancer Center

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
•Patients must have recurrent and/or metastatic disease not amenable to other curative intent therapy.
•At least 4 weeks must have elapsed since the end of prior systemic treatment and/or 2 weeks since completion of radiotherapy with resolution of all treatment related toxicity to NCI CTCAE Version 5.0 grade \<1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment.
•Patients must have RECIST V1.1 measurable disease, defined as at least one nonnodal lesion measuring ≥ 20 mm with conventional techniques or as ≥10mm with CT scan, MRI, or calipers by clinical exam in the longest dimension AND/OR a nodal lesion measuring ≥ 15 mm in the shortest dimension. Tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment.
•Patients must have documentation of a new or progressive lesion on radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within 6 months prior to study enrollment. Note: This assessment will be performed by the treating investigator and evidence of progression by RECIST criteria is not required.
•Age ≥ 18 years of age on the day of signing informed consent.
•ECOG performance status 0 or 1 (or Karnofsky ≥ 70%).
•Screening laboratory values must meet the following criteria:
•* Neutrophils ≥ 1500/μL
•* Platelets ≥ 100x10\^3/μL
+13 more criteria

Exclusion Criteria

•Untreated brain metastasis (subjects with treated brain metastases will be eligible, provided that they are radiographically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging \[note that the repeat imaging should be performed during study screening\], clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment).
•Prior malignancy if diagnosed and treated within 2 years of trial drug initiation. Patients may be included if they have completed therapy for a prior malignancy \>2 years prior to drug initiation and are currently no evidence of disease (NED). Exception: Participants with non-melanoma skin cancer or carcinoma in situ (breast DCIS, or cervical CIS) that have undergone potentially curative therapy at any time are not excluded from trial participation.
•Prior systemic anti-cancer therapy within 4 weeks of start of study treatment.
•≥ Grade 2 peripheral neuropathy per CTCAE v5.0 criteria.
•Dry eyes, keratitis, keratopathy, and active conjunctivitis.
•New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months (baseline echocardiogram is not required unless clinically indicated).
•Active infection, defined as any infection requiring systemic treatment
•Subject is known to be positive for Human Immunodeficiency Virus (HIV) or active Hepatitis C Virus (HCV) or active hepatitis B (HBV) infection (positive viral load). Testing for HIV, HCV, or HBV prior to initiation of the study drug is not required. If patient's have a known history of treated HCV, then a viral load is required to confirm clearance of infection.
•Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
•Renal failure requiring active hemo- or peritoneal dialysis.
+2 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

March 31, 2025

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2027

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Adenoid Cystic Carcinoma

Interventions

Enfortumab Vedotin

DRUG

Contacts

Alan Ho, MD, PhD

CONTACT

646-541-7062 hoa@mskcc.org

Winston Wong, MD

CONTACT

646-608-4245

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RECRUITINGEARLY_PHASE1

Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

Inclusion Criteria

Exclusion Criteria

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