Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Phase I Study of Safety, Tolerability, and Efficacy of Tebentafusp Using a Step-Up Dosing Regimen and Expansion in Patients With Metastatic Uveal Melanoma.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
59 citing papers in PubMed, 5 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Tebentafusp in Metastatic Uveal Melanoma: A Meta-analysis.Targeted oncology · 2026Pooled it
- Clinical outcomes of tebentafusp in metastatic uveal melanoma: a systematic review and single-arm meta-analysis.Frontiers in medicine · 2026Pooled it
- Efficacy and Safety of Tebentafusp in Uveal Melanoma: A Systematic Review and Single-Arm Meta-Analysis.Asian Pacific journal of cancer prevention : APJCP · 2025Pooled it
- Evaluating the efficacy and safety of tebentafusp in the treatment of metastatic uveal melanoma: a 2025 update systematic review and meta-analysis.Frontiers in oncology · 2025Pooled it
- Efficacy and safety of tebentafusp in patients with metastatic uveal melanoma: A systematic review and meta-analysis.Human vaccines & immunotherapeutics · 2024Pooled it
- Phase 1/2 study of IMC-C103C, a T cell receptor bispecific (MAGE-A4×CD3) ImmTAC targeting MAGE-A4-expressing malignancies.Journal for immunotherapy of cancer · 2026Trial
- Evolution of the tumor immune landscape during treatment with tebentafusp, a T cell receptor-CD3 bispecific.Cell reports. Medicine · 2025Trial
- Long-term survival follow-up for tebentafusp in previously treated metastatic uveal melanoma.Journal for immunotherapy of cancer · 2024Trial
- Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma.The New England journal of medicine · 2023Trial
- Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial.Nature medicine · 2022Trial
- Tebentafusp (IMCgp100), a first in class immune-mobilizing monoclonal T-cell receptors against cancer (ImmTAC) for HLA-A*02:01 positive uveal melanoma: Product review.Human vaccines & immunotherapeutics · 2026Review
- An anti-PMEL antibody-drug conjugate with a GNature medicine · 2026Article
- Dermatologic Adverse Events Associated with T-Cell Engager Therapy.American journal of clinical dermatology · 2026Review
- [Chinese Expert Consensus on Delta-like Ligand 3-T Cell Engager Therapy for SCLC].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2026Review
- Multi-omics data reveal B cell regulated immune heterogeneity of MIF signaling pathway in uveal melanoma.Cancer cell international · 2026Article
- Safety and biologic activity of a bispecific T cell receptor targeting HIV Gag in males living with HIV: a first-in-human trial.Nature communications · 2026Article
- Article
- Bispecific T-Cell Engagers, Cell Therapies, and Other Non-Checkpoint Immunotherapies for Metastatic Uveal Melanoma: A Narrative Review.Journal of clinical medicine · 2026Review
- Customized Marketing Strategies for Cancer Immunocyte Therapy Based on its Distinctive Attributes.Cancer management and research · 2026Review
- Clinical Development of T-Cell Bispecific Antibodies: Review, Challenges, and Prospective Solutions in Solid Tumor.Methods in molecular biology (Clifton, N.J.) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 9 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis phase I study aimed to define the recommended phase II dose (RP2D) of tebentafusp, a first-in-class T-cell receptor/anti-CD3 bispecific protein, using a three-week step-up dosing regimen, and to assess its safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity in patients with metastatic uveal melanoma (mUM).
methodsIn this open-label, international, phase I/II study, HLA-A*02 or HLA-A*02:01+ patients with mUM received tebentafusp 20 μg once in week 1 and 30 μg once in week 2. Dose escalation (starting at 54 μg) began at week 3 in a standard 3 + 3 design to define RP2D. Expansion-phase patients were treated at the RP2D (20-30-68 μg). Blood and tumor samples were collected for pharmacokinetics/pharmacodynamics assessment, and treatment efficacy was evaluated for all patients with baseline efficacy data as of December 2017.
resultsBetween March 2016 and December 2017, 42 eligible patients who failed a median of two previous treatments were enrolled: 19 in the dose escalation cohort and 23 in an initial dose expansion cohort. Of the dose levels investigated, 68 μg was identified as the RP2D. Most frequent treatment-emergent adverse events regardless of attribution were pyrexia (91%), rash (83%), pruritus (83%), nausea (74%), fatigue (71%), and chills (69%). Toxicity attenuated following the first three doses. The overall response rate was 11.9% (95% CI, 4.0 to 25.6). With a median follow-up of 32.4 months, median overall survival was 25.5 months (range, 0.89-31.1 months) and 1-year overall survival rate was 67%. Treatment was associated with increased tumor T-cell infiltration and transient increases in serum inflammatory mediators.
conclusionUsing a step-up dosing regimen of tebentafusp allowed a 36% increase in the RP2D compared with weekly fixed dosing, with a manageable side-effect profile and a signal of efficacy in mUM.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.