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