A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The Global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations.

The objective of module 1 will be to determine the overall response rate by RECIST 1.1 of atezolizumab in several arms. Subjects will be separated into arms depending on the mutations of their tumour. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vall d'Hebron Institute of Oncology
• Collaborators: IQVIA; Iqvia Pty Ltd; Roche Pharma AG
• Treatments: Antibodies, Monoclonal; Atezolizumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed malignancy that is metastatic or unresectable,

• who have progressed to standard therapy,

• who are receiving a standard anticancer treatment but no subsequent approved treatment would be available upon progression,

• who are unable to receive standard therapy, or

• for whom standard therapy does not exist

• ECOG performance status of 0 or 1.

• 18 year-old or older.

• Measurable disease according to RECIST 1.1.

• Enough tumor tissue for molecular analysis

• Patients providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 20 to 28 slides depending on the sample tumor cellularity. If there is not enough archival tissue to meet this criterion, the patient must undergo a tumor biopsy.

• Patients providing fresh frozen tissue must provide 4 core biopsies or equivalent. Fresh frozen tissue must be preferentially collected from a tumor biopsy; hence, patients must have disease amenable to be biopsied. Otherwise, the patient should have fresh frozen tumor tissue stored in a biobank or biorepository.

• Efforts will be made to provide fresh frozen tissue in at least one quarter of the participating patients.

• The proportion of patients that might provide fresh frozen tissue might change based on the results from the molecular analysis.

• Since some of the tests are performed in FFPE tissue, patients providing fresh frozen tissue from a recent biopsy will have part of the sample processed in formalin-fixed paraffin embedded tissue (FFPE) as per Laboratory manual.

• Adequate hematological, renal and hepatic function:

• For patients requiring a tumor biopsy, patients must have adequate coagulation function

• Quick time ≥ 60%

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Known brain metastases or leptomeningeal disease

• Spinal cord compression not definitively treated with surgery and/or radiation.

• Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF < 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Inability to swallow tablets or capsules

• Known HIV, hepatitis B or hepatitis C infection.

• Known history of malabsorption.

• Pregnant and lactating women