Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma of Unknown Primary
- Anal Carcinoma
- Lung Adenocarcinoma EGFR-mutated/ ALK Traslocation
- Thyroid Carcinoma
- Uterine Endometrial Carcinoma
- Lung Adenocarcinoma
- Bladder Carcinoma
- Cervical Carcinoma
- Cholangiocarcinoma
- Uveal Melanoma
- Stomach Adenocarcinoma
- Pancreatic Adenocarcinoma
- Small Cell Lung Cancer
- Colorectal Adenocarcinoma
- MSI-H Colorectal Cancer
- Other Histology
- Esophageal Adenocarcinoma
- Ovarian Serous Cystadenocarcinoma
- Prostate Adenocarcinoma
- Uterine Carcinosarcoma
- Lung Squamous Cell Carcinoma
- Sarcoma
- Triple -Negative Breast Cancer
- Squamous Esophageal Carcinoma
- Kidney Clear Cell Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Mesothelioma
- Hepatocellular Carcinoma
- HER2 Positive Breast Cancer
- Melanoma
- Hormone Receptor Positive / HER2-negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
A molecular pre-screening will be performed to know PD1 messenger RNA (mRNA) expression levels on a tumor sample using the nCounter-based technology. This will be centrally performed at Hospital Clinic of Barcelona. If the tumor is PD1-high (Cohort 1), as defined by the pre-specified cutoff, patient...
A molecular pre-screening will be performed to know PD1 messenger RNA (mRNA) expression levels on a tumor sample using the nCounter-based technology. This will be centrally performed at Hospital Clinic of Barcelona. If the tumor is PD1-high (Cohort 1), as defined by the pre-specified cutoff, patients (a total of 111) will receive spartalizumab 400 mg every four weeks. A cohort of 30 patients with PD1-low advanced solid tumors where the efficacy of PD1 inhibitors has been previously established (i.e. with a FDA or EMA monotherapy indication approved) will also be recruited (cohort 2). One of the aims of the study is to show the value of the biomarker independently of the tumor histology. Thus, a wide variety of cancer-types (30 different types) will be represented.
Tracking Information
- NCT #
- NCT04802876
- Collaborators
- Novartis
- Investigators
- Not Provided
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