BoB Trial and its results

As described in the “To know More” section, there are two phases in the BoB trial.

In the first phase (Part A, i-Profiler), tumor tissue is analyzed to assess whether there are genetic mutations that could be a target for the drug that will be administered in the second phase (Part B, i-Basket).

The second phase is the actual clinical trial, in which all patients with a certain mutation are treated with the same drug.

Currently 3 studies have been activated, each dedicated to a specific set of mutations:

1.

• Drug: atezolizumab
• Mode of administration: intravenous
• Posology: 1200 mg, once every 3 weeks
• Number of patients to be recruited (planned): 120
• Patients enrolment status: still ongoing

2.

• Drug: futibatinib
• Mode of administration: orally
• Posology: 20 mg, once daily continuously in 28-day cycles
• Number of patients to be recruited (planned): 80
• Patients enrolment status: still ongoing

3.

• Drug: amivantamab
• Mode of administration: intravenous
• Posology:
  • body weight <80Kg: 1050 mg, once a week in the first cycle and every 2 weeks in subsequent cycles.
  • body weight ≥80Kg: 1400 mg, once a week in the first cycle and every 2 weeks in subsequent cycles.
• Number of patients to be recruited (planned): 69
• Patient enrolment status: still ongoing

The 7 cancer centers, belonging to Cancer Core Europe, and involved in the patient recruitment process are: Gustave Roussy (France), German Cancer Research Center & National Center for Tumor Diseases Heidelberg (Germany), Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (Italy), Netherlands Cancer Institute (Netherlands), Vall d’Hebron Institute of Oncology (Spain), Karolinska Institutet (Sweden), Cancer Research UK Cambridge Centre (United Kingdom).

The BoB trial is active from December 2018 and is estimated to end by November 2026 (May 2025 as the assumed end date of patient recruitment).

For more information, you can visit https://clinicaltrials.gov/study/NCT03767075 or contact your oncologist, or the clinical staff involved in the treatment process.

Results

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