Study on Enfortumab Vedotin for Treating Adenoid Cystic Carcinoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT06891560

This clinical trial is testing whether the drug enfortumab vedotin is a safe and effective treatment for people with adenoid cystic carcinoma, a type of cancer that can occur in various parts of the body.

Patient Parameters

Program Overview

The aim of this study is to determine if enfortumab vedotin can be a safe and effective treatment option for individuals with adenoid cystic carcinoma (ACC), a rare type of cancer that can develop in different areas, including the salivary glands. The study will evaluate the drug's ability to treat ACC that has returned or spread and cannot be treated with other curative therapies.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenoid cystic carcinoma, including cases that do not originate from salivary glands.
  • Cancer must have returned or spread and cannot be treated with other curative therapies.
  • At least 4 weeks since last systemic treatment or 2 weeks since last radiotherapy, with recovery from any treatment-related side effects.
  • Must have measurable disease as defined by specific medical criteria.
  • Evidence of new or worsening disease within 6 months prior to joining the study.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 0 or 1.
  • Must provide a tissue sample from the primary tumor or metastases for study purposes.
  • Meet specific blood and organ function criteria based on lab tests.
  • Willing to sign an informed consent form.
  • Men must agree to use contraception and not donate sperm during and for 4 months after treatment.
  • Women must agree not to donate eggs during and for 3 weeks after treatment.
  • Women of childbearing potential must use effective contraception during and for 2 months after treatment.

Exclusion Criteria

  • Untreated brain metastases, unless stable and not requiring steroids.
  • Recent history of another cancer, unless treated and disease-free for over 2 years.
  • Recent systemic anti-cancer therapy within 4 weeks of starting the study.
  • Significant nerve damage or eye conditions.
  • Serious heart conditions or recent heart attack.
  • Active infections requiring treatment.
  • Positive for HIV, active Hepatitis B or C.
  • History of lung disease requiring steroids.
  • Kidney failure requiring dialysis.
  • Breastfeeding during and for 3 weeks after treatment.
  • Any condition that might interfere with the study or pose a risk to the participant.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (All protocol activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (All Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (All Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (All Protocol Activities)11553UniondaleNew York

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