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New treatment option for Adenoid Cystic Carcinoma
Official title A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
ClinicalTrials.gov ID: NCT06891560
What this study is testing
What is Enfortumab Vedotin?
Enfortumab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenoid cystic carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are...
- 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...
- Patients must have RECIST V1.1 measurable disease, defined as at least one nonnodal lesion measuring ≥ 20 mm with conventional techniques or as ≥10mm...
- Patients must have documentation of a new or progressive lesion on radiologic imaging study performed within 6 months prior to study enrollment...
You likely can't join if
- Untreated brain metastasis (people with treated brain metastases will be eligible, provided that they are radiographically stable, i.e. without...
- 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 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- Age ≥ 18 years of age on the day of signing informed consent.
- 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...
- 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...
- 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...
- 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.
What rules you out
- Untreated brain metastasis (people 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.