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