Drugs / Tebentafusp

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Kimmtrak 2022-04-01 europa.eu
Approved US (FDA) KIMMTRAK 2022-01-25 fda.gov

Trials 18 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT01209676 Sep 2010 → Mar 2013 melanoma University of Pennsylvania Completed No outcome recorded
Phase 11 trial
Phase 1 NCT01211262 Sep 2010 → Feb 2016 melanoma Immunocore Ltd Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT06626516 Oct 2025 → Oct 2030 expected uveal melanoma Thomas Jefferson University Recruiting No outcome recorded
Phase 1/2 NCT04262466 Feb 2020 → Oct 2026 expected cancer Immunocore Ltd Active not recruiting No outcome recorded
Phase 1/2 NCT02570308 Feb 2016 → Mar 2020 uveal melanoma Immunocore Ltd Completed No outcome recorded
Phase 1/2 NCT02535078 Nov 2015 → Jun 2023 melanoma Immunocore Ltd Withdrawn No outcome recorded
Phase 29 trials
Phase 2 NCT07276386 Dec 2025 → Dec 2030 expected uveal melanoma H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 2 NCT06942442 Oct 2025 → Oct 2030 expected MHC class I deficiency 2, clear cell sarcoma Sarcoma Alliance for Research through Collaboration Recruiting No outcome recorded
Phase 2 NCT06414590 Sep 2025 → Aug 2027 expected uveal melanoma Thomas Jefferson University Recruiting No outcome recorded
Phase 2 NCT06070012 Aug 2025 → Sep 2028 expected uveal melanoma Diwakar Davar Recruiting No outcome recorded
Phase 2 NCT07057596 Jul 2025 → Dec 2027 expected uveal melanoma Spanish Melanoma Group Recruiting No outcome recorded
Phase 2 NCT06627244 Feb 2025 → Feb 2028 expected uveal melanoma University of Miami Recruiting No outcome recorded
Phase 2 NCT05315258 Jul 2022 → Dec 2026 expected cutaneous melanoma, uveal melanoma University of Oxford Active not recruiting No outcome recorded
Phase 2 NCT03070392 Oct 2017 → Oct 2020 uveal melanoma Immunocore Ltd Completed No outcome recorded
Phase 2 NCT02889861 Jan 2017 → Apr 2019 melanoma Immunocore Ltd Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT06246149 Nov 2024 → Nov 2032 expected uveal melanoma European Organisation for Research and Treatment of Cancer - EORTC Recruiting No outcome recorded
Phase 3 NCT05549297 Dec 2022 → Mar 2028 expected melanoma Immunocore Ltd Recruiting No outcome recorded
Phase not stated1 trial
NCT04960891 uveal melanoma Immunocore Ltd Available No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT05785754 Background Jun 2023 → Dec 2026 expected DynamiCure Biotechnology Recruiting No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 20 sources stand behind the page.

FieldValueCited text
Known as tebentafusp “IMCgp100 (tebentafusp, Kimmtrak)” NCT03070392
12

NCT06627244

NCT07276386

NCT06070012

NCT05785754

NCT06246149

NCT06942442

NCT05315258

NCT04262466

NCT05549297

NCT02535078

NCT04960891

NCT07057596

Known as IMCgp100 “This study was a mixed phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent” NCT02535078
5

NCT02889861

NCT03070392

NCT01209676

NCT02570308

NCT01211262

Known as IMMTAC IMCGP100 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297990
Known as ImmTAC IMCgpgp 100 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297990
Known as Kimmtrak “IMCgp100 (tebentafusp, Kimmtrak)” NCT03070392
Known as Tebentafusp-Tebn ClinicalTrials.gov intervention name — accepted as the source's own label NCT06626516
1

NCT06414590

Action Activate “an anti-CD3 fragment that is meant to bind to and activate the T cells” NCT01209676
Modality Protein / enzyme biologic “a monoclonal T cell receptor anti-CD3scFv fusion protein” NCT01209676
Route Other “single intratumoral dose” NCT01209676
Target PMEL “Melanocyte protein PMEL binding agent” CHEMBL4297990