# Phase II study (KAMELEON) of single-agent T-DM1 in patients with HER2-positive advanced urothelial bladder cancer or pancreatic cancer/cholangiocarcinoma

Source: https://onco.cc/key-papers/paper-luca-gianni-cancer-med-2023/  
OnCo record `paper-luca-gianni-cancer-med-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Paper by Luca Gianni indexed on Europe PMC as PubMed record 37119523, in Cancer medicine (2023), one of the most cited records naming an author with this name at Fondazione Michelangelo.

## Summary

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.

Indexed on Europe PMC as PubMed record 37119523 (DOI 10.1002/cam4.5893). Its author list gives "Gianni L" with the affiliation "Michelangelo Foundation, Milan, Italy", which names Fondazione Michelangelo; that is how the record was matched to Luca Gianni, and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Cancer medicine
- Year: 2023
- DOI: 10.1002/cam4.5893
- Authors: de Vries EGE, Rüschoff J, Lolkema M, et al.
- What it means: One of the most cited papers Europe PMC returns for Luca Gianni at Fondazione Michelangelo, so it is a natural starting point for reading their work. The record was linked automatically from the author list and affiliation; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched to the person by surname, initials and an affiliation string naming the institution on the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Two authors sharing a surname, initials and institution cannot be told apart by this method; the person's profile links are the place to confirm authorship.

## Sources

- Cancer Med 2023: https://doi.org/10.1002/cam4.5893
- PubMed: https://pubmed.ncbi.nlm.nih.gov/37119523/
- Europe PMC: https://europepmc.org/article/MED/37119523

## Connected records

- people: [Luca Gianni](https://onco.cc/people/luca-gianni/)
- journals: [Cancer medicine](https://onco.cc/journals/cancer-medicine/)

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