Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
NCT04802876 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184
Last updated 2025-03-21
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.
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
- DRUG
-
Spartalizumab
Spartalizumab (PDR001) 400mg will be given intravenously every 28 days
- DRUG
-
Tislelizumab
Tislelizumab 300mg will be given intravenously every 28 days
Sponsors & Collaborators
- collaborator INDUSTRY
-
SOLTI Breast Cancer Research Group
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-12
- Primary Completion
- 2025-09-30
- Completion
- 2027-03-31
Countries
- Spain
Study Locations
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