NCT04802876

Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: SOLTI Breast Cancer Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• MSI-H Colorectal Cancer
• Melanoma
• Anal Carcinoma
• Mesothelioma
• Triple Negative Breast Cancer
• Lung Adenocarcinoma
• Cholangiocarcinoma
• Cervical Carcinoma
• Kidney Clear Cell Carcinoma
• Stomach Adenocarcinoma
• Esophageal Adenocarcinoma
• Uterine Adenocarcinoma
• Head and Neck Squamous Cell Carcinoma
• Sarcoma
• Lung Squamous Cell Carcinoma
• Urothelial Carcinoma
• Thyroid Carcinoma
• Hepatocellular Carcinoma
• Uveal Melanoma
• HER2-positive Breast Cancer
• Pancreatic Adenocarcinoma
• Squamous Esophageal Carcinoma
• Epithelial Ovarian Cancer
• Uterine Carcinosarcoma
• Small Cell Lung Cancer
• Hormone Receptor Positive / HER2-negative Breast Cancer
• Lung Adenocarcinoma EGFR-mutated/ ALK Traslocation
• Colorectal Adenocarcinoma
• Prostate Adenocarcinoma
• Carcinoma of Unknown Primary
• Other Histology

Interventions

Type	Name	Description
DRUG	Spartalizumab	Spartalizumab (PDR001) 400mg will be given intravenously every 28 days
DRUG	Tislelizumab	Tislelizumab 300mg will be given intravenously every 28 days

Timeline

• Start date: 2021-04-12
• Primary completion: 2025-09-30
• Completion: 2027-03-31
• First posted: 2021-03-17
• Last updated: 2025-03-21

Locations

1 site across 1 country: Spain