Study design and patients
Tumors, tumor, tumors, cholangiocarcinoma
TUMOR, SOLID TUMORS, TUMORS, PANCREATIC CANCER, TUMORS, CHOLANGIOCARCINOMA
KAMELEON was a multicenter, exploratory, non‐randomized, single‐arm, phase II study (NCT02999672). It was investigator‐initiated, but eventually received corporate sponsorship (Roche). KAMELEON, which was conducted at 10 sites across Italy, Spain, and the Netherlands, sought to determine the best tumor response following treatment with T‐DM1 in patients with HER2‐overexpressing solid tumors. Eligible adults (≥18 years) had HER2‐positive locally advanced (unresectable and not treatable with curative intent) or metastatic UBC or locally advanced or metastatic pancreatic cancer/cholangiocarcinoma measurable per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.In the pre‐trial IHC analyses, 25.0% (11/44) of patients with UBC, 0% (0/62) with pancreatic cancer, and 7.1% (3/42) with cholangiocarcinoma had tumors exhibiting complete membrane staining in ≥30% of stained cells. Since HER2 heterogeneity is prevalent in UBCThis study was performed in compliance with the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice, and applicable national and local regulatory requirements. The study protocol was approved by the Independent Ethics Committee or Institutional Review Board at each participating site. Written informed consent was obtained from patients for the clinical and exploratory biomarker analyses.