A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
ConditionAdenoid Cystic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Enfortumab Vedotin
Drugintravenously 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
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Enfortumab VedotinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
best overall response rate
BOR; CR+PR by RECIST v1.1
Time frame
1 yearSecondary outcomes
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.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Astellas Pharma US, Inc.
Collaborator
Source ClinicalTrials.gov