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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tebentafusp
DrugAn anti-cancer medication used to treat uveal melanoma. Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Tebentafusp (IMCgp100)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in ctDNA response
ctDNA response (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured by tumor-informed ctDNA assay.
Time frame
At Baseline, at Week 10 of each 12-week cycle, Up to 24 months]Secondary outcomes
1
Objective Response Rate (ORR)
ORR as assessed imRECIST. Percentage of patients with partial response (PR) or complete response (CR) to the treatment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame
Up to 36 months2
Overall Survival (OS)
Median length of time from start of treatment that patients remain alive.
Time frame
Up to 5 years3
1-year Overall Survival (OS)
The percentage of patients alive at one year after start of treatment.
Time frame
At one year (post start of treatment)4
2-year Overall Survival (OS)
The percentage of patients alive at two years after start of treatment.
Time frame
At two years (post start of treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov