# IMCgp100-202

Source: https://onco.cc/trials/imcgp100-202/  
OnCo record `imcgp100-202` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first drug ever to extend life in metastatic uveal melanoma, and the first T-cell receptor-based medicine to win a phase 3.

## Summary

IMCgp100-202, trial NCT03070392 sponsored by Immunocore and reported in 2021, produced the first drug ever to extend life in metastatic uveal melanoma and the first T-cell receptor-based medicine to win a phase 3. It randomised 378 untreated HLA-A*02:01-positive patients to tebentafusp or investigator's choice of pembrolizumab, ipilimumab or dacarbazine and met its primary overall survival endpoint despite a low response rate, showing that circulating tumour DNA reduction and slowed growth matter more than RECIST shrinkage for this class; approval followed in January 2022, with cytokine release syndrome and rash manageable through step-up dosing. There is no second randomised trial, and whether the approach transfers to cutaneous melanoma, as PRISM-MEL-301 tests, is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03070392
- Phase: 2
- Setting: Untreated HLA-A*02:01-positive metastatic uveal melanoma: tebentafusp vs investigator's choice (pembrolizumab, ipilimumab, or dacarbazine)
- Sponsor: Immunocore
- Enrolled: 378
- Result: OS 21.7 vs 16.0 months; HR 0.51.
- Outcomes: Overall survival: Tebentafusp 21.7 months vs Investigator's choice 16 months, HR 0.51
- Replication: Supported by a phase 2 in previously treated uveal melanoma; no second randomised trial.

## Sources

- ClinicalTrials.gov NCT03070392: https://clinicaltrials.gov/study/NCT03070392
- NEJM 2021: https://www.nejm.org/doi/full/10.1056/NEJMoa2103485

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD3](https://onco.cc/targets/cd3/), [gp100 (PMEL)](https://onco.cc/targets/gp100/)
- drugs: [Tebentafusp](https://onco.cc/drugs/tebentafusp/)
- companies: [Immunocore](https://onco.cc/companies/immunocore/)
- people: [Paul Nathan](https://onco.cc/people/paul-nathan/), [Richard D. Carvajal](https://onco.cc/people/richard-carvajal/)
- key papers: [Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma](https://onco.cc/key-papers/paper-imcgp100-202-n-engl-j-med-2021/), [Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma](https://onco.cc/key-papers/paper-imcgp100-202-n-engl-j-med-2023-update/)
- trials: [FOCUS](https://onco.cc/trials/nct02678572/)

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