Actively Recruiting
A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-20
34
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of adenoid cystic carcinoma, including cancers from non-salivary gland primary sites
- Recurrent and/or metastatic disease not suitable for curative treatment
- At least 4 weeks since last systemic treatment and 2 weeks since radiotherapy with recovery from related side effects
- Measurable disease by RECIST V1.1 criteria
- Evidence of new or worsening tumor or symptoms within 6 months prior to enrollment
- Age 18 years or older
- ECOG performance status 0 or 1, or Karnofsky score 70% or higher
- Availability of tumor tissue for research purposes, or approval by the Investigator if not available
- Screening lab tests meeting specified blood counts and organ function levels
- Willingness to sign informed consent
- Male participants agree to use contraception and avoid sperm donation during treatment and for 4 months after
- Female participants agree not to donate eggs during the study and for 3 weeks after last dose
- Female participants must not be pregnant or be of non-childbearing potential, or if childbearing potential, must use effective contraception throughout treatment and 2 months after
You will not qualify if you...
- Untreated brain metastases; treated brain metastases must be stable without progression for at least 4 weeks and no steroid use for 14 days prior to treatment
- Prior malignancy treated within 2 years before study drug start, except certain skin and in situ cancers
- Systemic anti-cancer therapy within 4 weeks of starting study treatment
- Grade 2 or higher peripheral neuropathy
- Dry eyes, keratitis, keratopathy, or active conjunctivitis
- Significant heart conditions within past 6 months
- Active infection requiring systemic treatment
- Known HIV infection or active hepatitis B or C infection
- History or current pneumonitis or interstitial lung disease requiring steroids
- Renal failure requiring dialysis
- Breastfeeding during treatment and for 3 weeks after last dose
- Any other medical condition or abnormality that could interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alan Ho, MD, PhD
CONTACT
W
Winston Wong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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