Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03070392 | Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma | PHASE2 | COMPLETED | 378 | — | — | Oct 16, 2017 | Sep 17, 2025 | Mar 17, 2026 | 57 | United States, Australia +12 |
| NCT02570308 | A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma | PHASE1 | COMPLETED | 146 | — | — | Feb 29, 2016 | Oct 17, 2022 | Mar 21, 2023 | 26 | United States, Canada +3 |
Overall survival is defined as the time from randomization to date of death due to any cause.
Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria.
Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline.
| Arm | Type | Description |
|---|---|---|
| IMCgp100 (tebentafusp, Kimmtrak) | EXPERIMENTAL | Biologic:IMCgp100 (Soluble gp 100-specific T cell receptor with anti - CD3 scFV: IMCgp100) |
| Investigator's Choice | ACTIVE_COMPARATOR | 1 of 3 Investigator's Choice options: Systemic Dacarbazine 1 of 3 Investigator's Choice options: Systemic Ipilimumab 1 of 3 Investigator's Choice options: Systemic Pembrolizumab |
| Dose escalation | EXPERIMENTAL | Dose escalation cohorts of the intra-patient escalation regimen. |
| Dose expansion | EXPERIMENTAL | Dose expansion cohort with the recommended phase 2 dose of the intra-patient dose escalation regimen. |
| Name | Type | Description |
|---|---|---|
| IMCgp100 | BIOLOGICAL | IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity |
| Dacarbazine | DRUG | Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity |
| Ipilimumab | BIOLOGICAL | Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity |
Inclusion Criteria 1. Male or female participants age ≥ 18 years of age at the time of informed consent 2. Ability to provide and understand written informed consent prior to any study procedures 3. Histologically or cytologically confirmed metastatic UM 4. Must meet the following criteria related ...