VHIO17002

Principal investigator

Dr. F.L. Opdam

Medication

Atezolizumab (anti-PDL1 antibody), futibatinib (FGFR inhibitor), amivantamab

Summary

So-called 'basket studies' are a new type of medical-scientific research to detect subjects with the same type of mutations and treat them with the same research drug, regardless of the specific type of cancer they have.

In basket studies, subjects are divided into different groups or 'baskets', depending on the type of mutation they have. It is then determined which treatments block this mutation (targeted therapies) and which treatments are given to the subjects in the different groups. Aim of the study: The overall aim of the study is to find tailor-made cancer treatments, based on an analysis of the genetic characteristics of tumors.

Research design: 'Basket of Baskets' is a medical-scientific study that consists of two parts. Part A (I-Profiler) is the part of the study in which the tumor tissue is examined for the mutations that occur the tumor. This is done by means of laboratory tests that look at whether one or more mutations are present in the tumor that could be a target for treatment with a specific research drug. Part B (I-Basket) is the therapeutic part of the study. In Part B, we investigate the effect of a specific treatment for subjects with the same type of mutation in their tumors."

Read more on clinicaltrials.gov

Patient population

Tumor characteristics : POLE mutation, POLD1 mutation, Intermediate mutational burden (≥ 12-16 mutations/Mb), PDL-1 amplified, FGFR1-3 mutation, FGFR1-3 amplification, FGFR1+, FGFR2+.

Notes:

Cohort 1:

• Arm 1A: BRCA1 or BRCA2 mutations – closed
• Arm 1B: MLH1, MSH2, MSH6, or PMS2 mutations – closed
• Arm 1C: tumors with POLE mutation, POLD1 mutation – closed
• Arm 1D: hypermutated tumors – closed
• Arm 1E: tumors with other mutations in DNA repair genes – closed
• Arm 1F: tumors with amplified PDL1 – closed
• Arm 1G: CDK12 mutation – closed

Cohort 2:

• Arm 2A: FGFR1-3 mutation – closed
• Arm 2B: FGFR1-3 mutation, VUS only – open
• Arm 2C: FGFR1-3 amplification – open
• Arm 2D: FGFR1 amplification – closed

Cohort 3:

• Arm 3A: MET mutation, MET+ – open
• Arm 3B: WITH amplification – open
• Arm 3C: EGFR mutation – open