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Adenoid Cystic CarcinomaPhase 2NCT06891560

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

A Phase 2 study testing Enfortumab Vedotin in people with Adenoid Cystic Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenoid Cystic Carcinoma
What is being tested?
Enfortumab Vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
7 sitesUnited States
Study dates
31 Mar 2025to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • ECOG performance status 0 or 1 (or Karnofsky ≥ 70%).
  • Patients must have tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or at least 20 unstained slides are acceptable (paraffin block or at 30 unstained slides would be ideal). Patients without available tissue for submission may still be eligible if approved by the Principal Investigator. Additional tissue collection is not a requirement for this study.
  • Screening laboratory values must meet the following criteria:
  • Neutrophils ≥ 1500/μL
  • Platelets ≥ 100x10^3/μL
  • Hemoglobin > 9.0 g/dL (without packed red blood cell (pRBC) transfusion within the last 2 weeks)
  • AST and ALT ≤ 2.5 x ULN (if liver metastases are present, AST and ALT ≤ 5x ULN)
  • Total Bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 x ULN (except participants with Gilbert Syndrome, who can have a total bilirubin < 3.0 mg/dL)
  • Serum creatinine ≤ 1.5 x ULN OR creatinine clearance (CrCl) ≥ 40 mL/min per the Cockcroft-Gault formula if creatinine is >1.5 x ULN
  • Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
  • Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
  • Participants must be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial specific procedure.
  • Male participants must agree to use adequate contraception and refrain from donating sperm from start of therapy through 4 months after last dose of trial treatment.
  • Female participants must agree not to donate ova starting at screening and throughout the study period, and for at least 3 weeks after the final dose of study drug.
  • A female participant is eligible to participate if 1) she is not pregnant (for women of child-bearing potential, a pregnancy test must be negative within 72 hours prior to initiation; if a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required) OR 2) she is not a woman of child bearing potential as defined by one of the following criteria:
  • Pre-menopausal with one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy
  • Postmenopausal females defined as no menses for 12 months without an alternative medical cause. However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.
  • A woman of childbearing potential must use highly effective contraception from the start of therapy through 2 months after the last dose of study medication.

Who cannot join

  • 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).
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  • 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.
  • Breast feeding is not allowed from the start of treatment through 3 weeks after the last dose of study drug.
  • Has a history or current evidence of any medical or other condition, therapy or laboratory abnormality which, in the opinion of the investigator, might confound the results of the study, or preclude participation in a clinical study.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alan Ho, MD, PhD contact

646-541-7062

hoa@mskcc.org

Winston Wong, MD contact

646-608-4245

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Alan Ho, MD. PhD, 646-541-7062

    Recruiting

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

    Commack, New York, 11725

    Alan Ho, MD, PhD, 646-541-7062

    Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    East White Plains, New York, 10604

    Alan Ho, MD, PhD, 646-541-7062

    Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

    Alan Ho, MD, PhD, 646-541-7062

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

    Alan Ho, MD, PhD, 646-541-7062

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Alan Ho, MD. PhD, 646-541-7062

    Winston Wong, MD, 646-608-4245

    Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York, 11553

    Alan Ho, MD, PhD, 646-541-7062

    Recruiting

Other trials in United States

About this study

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

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).

Being tested
Enfortumab Vedotin
Keywords
Enfortumab Vedotin, 24-215
Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enfortumab VedotinDrug

    intravenously on Days 1, 8 and 15 of a 28-day cycle-dose can be done up to +/-3 days after the scheduled day of administration

Study groups in NCT06891560
Study groupRoleWhat they receive
Enfortumab VedotinExperimentalParticipants 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.
Receives: Drug: Enfortumab Vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. best overall response rate

    BOR; CR+PR by RECIST v1.1

    Measured: 1 year

Secondary outcomes (1)

  1. progression-free survival (PFS)

    PFS will be estimated using Kaplan-Meier methodology, with time origin at the start of the treatment. Patients will be followed until progression of disease or death, whichever comes first.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start31 Mar 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open label phase II clinical trial.
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891560
Sponsor's protocol ID
24-215
Status last verified
Sep 2026
First submitted
18 Mar 2025
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enfortumab Vedotin in people with Adenoid Cystic Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alan Ho, MD, PhD (646-541-7062, hoa@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

best overall response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06891560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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