Actively Recruiting
Phase II Trial of Enfortumab Vedotin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-20
34
Participants Needed
7
Research Sites
N/A
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
Researchers are evaluating enfortumab vedotin as a potential treatment for people with adenoid cystic carcinoma (ACC), a type of cancer that may be recurrent or metastatic. This phase II trial aims to assess whether this drug is effective and safe for individuals whose cancer cannot be cured by other therapies. The study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on patients with measurable disease and recent progression or worsening symptoms. Participants receive enfortumab vedotin intravenously on Days 1, 8, and 15 of each 28-day treatment cycle. The dosing schedule allows for a window of plus or minus three days around each administration day. This treatment continues through multiple cycles as determined by the study protocol. There are no placebo groups; all participants receive the study drug. During the trial, participants will undergo regular assessments including imaging to measure tumor response, laboratory tests to monitor health status, and documentation of any side effects. The main outcome the researchers will evaluate is the best overall response rate within one year. They will also observe progression-free survival over the same period. Participants are expected to sign informed consent and adhere to contraception requirements if applicable. Safety and treatment effects will be closely monitored throughout the study period.
CONDITIONS
Brief Title
A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma, including cancers from non-salivary gland sites.
- Patients must have recurrent and/or metastatic disease not suitable for curative therapy.
- At least 4 weeks since prior systemic treatment and 2 weeks since radiotherapy with resolved toxicity to mild levels.
- Patients must have measurable disease by RECIST V1.1 criteria.
- Documentation of new or progressive lesion or worsening disease symptoms within 6 months prior to enrollment.
- Age 18 years or older at informed consent.
- ECOG performance status 0 or 1 or Karnofsky score at least 70%.
- Availability of tumor tissue for correlative studies.
- Screening labs meeting specified blood counts and organ function criteria.
- Willingness to sign informed consent.
- Male participants must use contraception and avoid sperm donation during and 4 months after treatment.
- Female participants must not donate ova during and at least 3 weeks after treatment.
- Female participants must not be pregnant or be non-childbearing as defined, and use effective contraception during and 2 months after treatment.
You will not qualify if you...
- Untreated brain metastases; treated brain metastases must be stable for at least 4 weeks without steroids.
- Prior malignancy diagnosed and treated within 2 years before study drug start, except certain skin or in situ cancers.
- Systemic anti-cancer therapy within 4 weeks before study treatment.
- Grade 2 or higher peripheral neuropathy.
- Eye conditions including dry eyes, keratitis, keratopathy, or active conjunctivitis.
- Significant heart conditions including recent heart attack or severe heart failure.
- Active infection requiring systemic treatment.
- Known active HIV, hepatitis B or C infection.
- History or current pneumonitis or interstitial lung disease requiring steroids.
- Renal failure requiring dialysis.
- Breastfeeding during study and 3 weeks after last dose.
- Any other medical or laboratory condition that may interfere with study participation as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive enfortumab vedotin intravenously on Days 1, 8, and 15 of each 28-day cycle.
3 visits per cycle (in-person)
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
W
Winston Wong, MD
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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