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Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors — ACROPOLI  

Hepatocellular Carcinoma Clinical Trial

Official title:
Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Defined by a Single and Pre-specified Cutoff

Clinical Trial Summary

This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors.

Clinical Trial Description

Patients will sign a molecular pre-screening consent form across centers in Spain that will allow determination of PD1 mRNA expression on a tumor sample using the nCounter-based technology. This will be centrally performed at Hospital Clinic of Barcelona. In this trial, three patient cohorts are planned: - Cohort 1: patients with PD1-high tumors, as defined by the pre-specified cutoff, who will be treated with spartalizumab in monotherapy (400mg/IV every 28 days). - Cohort 2: patients with PD1-low advanced solid tumors where the efficacy of PD1 / PD-L1 inhibitors has been previously established (i.e. with a FDA or EMA monotherapy indication approved) will also be recruited and treated with spartalizumab in monotherapy (400mg/IV every 28 days). - Cohort 3: patients with PD1-high tumors, as defined by the pre-specified cutoff, who will be treated with tislelizumab in monotherapy (300mg/IV every 28 days). ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Adenocarcinoma of Lung
  • Anal Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma of Unknown Primary
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Squamous Cell
  • Carcinosarcoma
  • Cervical Carcinoma
  • Cholangiocarcinoma
  • Colorectal Adenocarcinoma
  • Epithelial Ovarian Cancer
  • Esophageal Adenocarcinoma
  • Esophageal Neoplasms
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • HER2-positive Breast Cancer
  • Hormone Receptor Positive / HER2-negative Breast Cancer
  • Kidney Clear Cell Carcinoma
  • Lung Adenocarcinoma
  • Lung Adenocarcinoma EGFR-mutated/ ALK Traslocation
  • Lung Squamous Cell Carcinoma
  • Melanoma
  • Mesothelioma
  • MSI-H Colorectal Cancer
  • Other Histology
  • Pancreatic Adenocarcinoma
  • Prostate Adenocarcinoma
  • Sarcoma
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Esophageal Carcinoma
  • Stomach Adenocarcinoma
  • Thyroid Carcinoma
  • Thyroid Neoplasms
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Urothelial Carcinoma
  • Uterine Carcinosarcoma
  • Uveal Melanoma
Clinical Trial Details
NCT number NCT04802876
Study type Interventional
Source SOLTI Breast Cancer Research Group
Contact Fernando Salvador, PhD
Phone +34 616 19 44 78
Email fernando.salvador@gruposolti.org
Status Recruiting
Phase Phase 2
Start date April 12, 2021
Completion date March 31, 2027
View Details
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