Trial reportCancer medicine2023
Phase II study (KAMELEON) of single-agent T-DM1 in patients with HER2-positive advanced urothelial bladder cancer or pancreatic cancer/cholangiocarcinoma.
Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02999672 (Phase II, Exploratory, Multicenter, Non Randomized, Single Agent Cohort Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors), which is not on this map. Cited by 37 papers, 2 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.
Phase II, Exploratory, Multicenter, Non Randomized, Single Agent Cohort Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- Efficacy and safety of antibody-drug conjugate based therapy in locally advanced or metastatic urothelial carcinoma: a systematic review and network meta-analysis of emerging clinical evidence.Frontiers in immunology · 2026Pooled it
- Efficacy and safety of antibody-drug conjugates in the treatment of urothelial cell carcinoma: a systematic review and meta-analysis of prospective clinical trials.Frontiers in pharmacology · 2024Pooled it
- Phase II study (KAMELEON) of single-agent T-DM1 in patients with HER2-positive advanced urothelial bladder cancer or pancreatic cancer/cholangiocarcinoma.Cancer medicine · 2023Trial
- Advancing antibody drug conjugates in gastrointestinal cancers.British journal of cancer · 2026Review
- Chinese expert consensus on precision testing and molecular diagnosis of pancreatic cancer (2025).British journal of cancer · 2026Article
- Predictive Immunohistochemistry in Cholangiocarcinoma: Current Clinical Utility, Practical Limitations, and Emerging Directions.APMIS : acta pathologica, microbiologica, et immunologica Scandinavica · 2026Review
- Targeting Biliary Tract Cancers with Antibody-Drug Conjugates: Advances in Molecular Targets and Rational Combinations.Cancers · 2026Review
- HER2 and urothelial carcinoma: current understanding and future directions.Nature reviews. Urology · 2026Review
- Review
- Avidity-optimized TCR-T cells target KRAS neoantigens for potent cancer clearance and tumor microenvironment remodeling.Frontiers in immunology · 2026Article
- Bispecific Antibody and Antibody-Drug Conjugate as Novel Candidates for Treating Pancreatic Ductal Adenocarcinoma.Biomolecules · 2025Review
- HER2-Positive Urothelial Carcinoma: Current Evidence on Targeted Agents and Immunotherapy-Based Combinations.Targeted oncology · 2025Review
- Cytokine Therapy in Bladder Cancer: Mechanisms, Efficacy, and Future Prospects.Current issues in molecular biology · 2025Review
- Single-center analysis of a real-world cohort of patients with metastatic urothelial carcinoma evaluated by NGS: molecular landscape and efficacy of targeted therapies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
- Efficacy and safety of antibody-drug conjugates in the treatment of advanced urological cancers: a systematic review and a meta-analysis.Frontiers in pharmacology · 2025Review
- A radiomics-based interpretable machine learning model to predict the HER2 status in bladder cancer: a multicenter study.Insights into imaging · 2024Article
- Prognostic and Predictive Roles of HER2 Status in Non-Breast and Non-Gastroesophageal Carcinomas.Cancers · 2024Review
- New Advances in Metastatic Urothelial Cancer: A Narrative Review on Recent Developments and Future Perspectives.International journal of molecular sciences · 2024Review
- Review
- Extrahepatic Cholangiocarcinoma: Genomic Variables Associated With Anatomic Location and Outcome.JCO precision oncology · 2024Article
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 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The antibody-drug conjugate trastuzumab emtansine (T-DM1) is approved for human epidermal growth factor receptor 2 (HER2/ERBB2)-positive breast cancer. We aimed to study tumor HER2 expression and its effects on T-DM1 responses in patients with HER2-positive urothelial bladder cancer (UBC) or pancreatic cancer (PC)/cholangiocarcinoma (CC). In the phase II KAMELEON study (NCT02999672), HER2 status was centrally assessed by immunohistochemistry, with positivity defined as non-focal homogeneous or heterogeneous overexpression of HER2 in ≥30% of stained cells. We also performed exploratory biomarker analyses (e.g., gene-protein assay) on tissue samples collected from study participants and consenting patients who failed screening. Of the 284 patients successfully screened for HER2 status (UBC, n = 69; PC/CC, n = 215), 13 with UBC, four with PC, and three with CC fulfilled eligibility criteria. Due to recruitment difficulty, the sponsor terminated KAMELEON prematurely. Of the five responders in the UBC cohort (overall response rate, 38.5%), HER2 expression was heterogeneous in two and homogeneous in three. The one responder in the PC/CC cohort had PC, and the tumor displayed homogeneous expression. In the biomarker-evaluable population, composed of screen-failed and enrolled patients, 24.3% (9/37), 1.5% (1/66), and 8.2% (4/49) of those with UBC, PC, or CC, respectively, had HER2-positive tumors. In a gene-protein assay combining in situ hybridization with immunohistochemistry, greater HER2 homogeneity was associated with increased ERBB2 amplification ratio. In conclusion, KAMELEON showed that some patients with HER2-positive UBC or PC can respond to T-DM1 and provided insight into the prevalence of HER2 positivity and expression patterns in three non-breast tumor types.
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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.