Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

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