drugset / Trial / NCT03070392
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.
Timeline
- Start
- 2017-10-16
- Primary completion
- 2020-10-13
- Completion
- 2025-09-17
Publications
- Piperno-Neumann S, Rutkowski P, Hassel JC, Butler MO, Schlaak M, Sullivan RJ, Dummer R, Kirkwood JM, Sacco JJ, Shoushtari AN, Piulats JM, Salama AKS, Orloff MM, Joshua AM, Ochsenreither S, Gastaud L, Curti BD, Demidov LV, Milhem MM, Chmielowski B, Kendra KL, Ascierto PA, Bernicker EH, Carvajal RD, Collins L, Lockwood S, Patel JM, Hamid OA, Baurain JF, Nathan PD. Five-year survival with tebentafusp in metastatic uveal melanoma. Ann Oncol. 2026 May 19:S0923-7534(26)00879-3. doi: 10.1016/j.annonc.2026.05.695. Online ahead of print.
- Hassel JC, Piperno-Neumann S, Rutkowski P, Baurain JF, Schlaak M, Butler MO, Sullivan RJ, Dummer R, Kirkwood JM, Orloff M, Sacco JJ, Ochsenreither S, Joshua AM, Gastaud L, Curti B, Piulats JM, Salama AKS, Shoushtari AN, Demidov L, Milhem M, Chmielowski B, Kim KB, Carvajal RD, Hamid O, Collins L, Ranade K, Holland C, Pfeiffer C, Nathan P. Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2023 Dec 14;389(24):2256-2266. doi: 10.1056/NEJMoa2304753. Epub 2023 Oct 21.
- Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dacarbazine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tebentafusp | Protein / enzyme biologic | 68 ug | Intravenous |