Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiwakar Davar
About this trial
This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.
Eligibility criteria
Qualifiers
If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A*0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method.
If the patient is known to be HLA-A*0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI and Sponsor-Investigator prior to enrollment.
Multiplex real-time PCR based testing performed by entities including but not limited to Labcorp, and American Red Cross.
HLA testing as part of peripheral blood molecular profiling technology including but not limited to Caris Life Sciences Molecular Profiling Technology.
Disqualifiers
History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment.
QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.
NOTE: If the initial automated QTcF interval is > 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes), should be manually determined by a medically qualified person.
Trial design
Treatments tested in this trial
- Tebentafusp
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov