Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tebentafusp · 5 trials · 6 indications
RFS is defined as the time between randomization and local recurrence, distant recurrence, or death, whichever occurs first
OS is the time from randomization to death due to any cause.
ctDNA response (defined as ≥0.3 log reduction) in ctDNA-evaluable patients as measured using Signatera assay.
Progression-free survival (PFS) will be defined as the elapsed time in months from the first date of study treatment until documented disease progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever is earlier. For participants who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
The number of participants experiencing treatment-related adverse events (AEs) and serious adverse events (SAEs) in participants receiving protocol therapy will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5, per physician discretion.
Best response to treatment, with partial molecular response (pMR) defined as a decrease in the allele frequency of the index mutation(s), and complete molecular response (cMR) as no detectable mutation(s)
| Arm | Type | Description |
|---|---|---|
| Tebentafusp | EXPERIMENTAL | Participants will receive tebentafusp 20 mcg on week 1, 30 mcg on week 2, 68 mcg on week 3, and 68 mcg weekly thereafter for 6 months i.e., maximum 26 infusions. |
| Observation | NO_INTERVENTION | - |
| Arm A: Tebentafusp Monotherapy | EXPERIMENTAL | Participants receive tebentafusp as single agent. |
| Arm B: Tebentafusp + Pembrolizumab | EXPERIMENTAL | Participants receive tebentafusp in combination with pembrolizumab. |
| Arm C: Investigator's Choice | EXPERIMENTAL | Participants receive investigator's choice of therapy. |
| Tebentafusp (IMCgp100) | EXPERIMENTAL | Dose: 20mcg W1D; 30mcg W2D1; 68mcg W3D1and subsequent doses Frequency: Weekly on D1 of 12-week cycles |
| Tebentafusp in combination with Radioembolization Group | EXPERIMENTAL | Participants in this group will first be administered Yttrium 90 Trans-Arterial Radioembolization (Y90 TARE) therapy, followed by a 14 to 28 day recovery period. Participants will then be administered Tebentafusp once weekly during every 28-day cycle. Participants may receive up to 24 months or 24 cycles of Tebentafusp therapy. Total participation is about 3 years. |
| Cutaneous melanoma with molecular relapsed disease | EXPERIMENTAL | tebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months. |
| Uveal melanoma with molecular relapsed disease | EXPERIMENTAL | tebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months. |
| Name | Type | Description |
|---|---|---|
| Tebentafusp | DRUG | Tebentafusp will be administered weekly i.v. |
| Tebentafusp with Pembrolizumab | DRUG | Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab |
| Investigators Choice | DRUG | Investigators choice of therapy |
| TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization | RADIATION | Participants will undergo radiographic and 99mTC-labeled macroaggregated albumin (99mTc-MAA) assessment for suitability prior to Y-90 absorbed glass microsphere treatment per institutional procedures. Y-90 trans-arterial radioembolization (TARE) is a standard of care treatment for intrahepatic metastases of uveal melanoma as indicated in the National Comprehensive Cancer Network (NCCN) consensus guidelines (NCCN Guidelines®, 2023). Y-90 absorbed glass microspheres will be administered at least one time prior to initiating Tebentafusp treatment. After the Y90-TARE procedure, participants will have a 14- to 28-day Y-90 TARE Recovery Period. |
Inclusion Criteria: * Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy * Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks ) * High-risk according to eith...