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

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ClinicalTrials.gov Identifier: NCT03767075
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : October 6, 2020
Sponsor:
Collaborators:
Roche Pharma AG
Iqvia Pty Ltd
Information provided by (Responsible Party):
Vall d'Hebron Institute of Oncology

Tracking Information
First Submitted Date  ICMJE November 14, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date October 6, 2020
Actual Study Start Date  ICMJE December 10, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Overall response rate by RECIST 1.1 [ Time Frame: 12 weeks ]
For the purposes of the primary endpoint of this study, subjects will be evaluated for response and progression using the new international criteria proposed by the revised RECIST guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Mean progression free survival (PFS by RECIST 1.1) of the subjects participating in iBASKET [ Time Frame: through study completion, an average of 3 years. ]
  • Progression Free Survival (PFS by RECIST 1.1) [ Time Frame: 6 months. ]
  • Mean overall survival of subjects treated with targeted therapy in iBASKET [ Time Frame: through study completion, an average of 3 years. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
Official Title  ICMJE Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours
Brief 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

Detailed Description

Basket studies are a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies, depending on the mutation types, patients are classified into "baskets". Targeted therapies that block that mutation are then identified and assigned to baskets where patients are treated accordingly.

This protocol has two parts: part A (iPROFILER), which includes the common procedures for tumor molecular profiling and treatment recommendation, and part B (iBASKET), which corresponds to the therapeutic portion The purpose of part A (iPROFILER) of this study is to test participants' tumour tissue in order to identify whether their tumour has certain mutations in cancer-related genes. It is known that gene mutations of tumours contribute to their origin and growth and determine whether the tumour will respond to particular cancer drugs. This test will provide information about potential targeted therapies that specifically attack those gene mutations. The purpose of part B (iBASKET) of this study is to offer participants a personalised anti-cancer treatment based on the gene mutations that are found in their tumour. Participants taking part in this module 1 of part B (iBASKET), in genomically selected populations, will receive atezolizumab 1200mg intravenously every 3 weeks, following the analysis of their tumour in part A (iPROFILER). Participants will be able to take atezolizumab for as long as their tumour doesn't grow and for as long as they don't have any side-effects which prevent them from continuing treatment.

The study will have a 2-year recruitment period. The aim of the study is to determine which genomically selected populations respond effectively to the targeted treatment, atezolizumab. Approximately 1000 participants will be enrolled into part A (iPROFILER), with approximately 100 participants being recruited into module 1 of part B (iBASKET)."

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
  • Part A includes a molecular profiling program for subjects with advanced solid tumors (iPROFILER) and a molecular tumor board to select the most appropriate treatment based on the molecular alterations found in the iPROFILER.
  • Part B includes iBASKET, a modular investigator initiated basket study for subjects with selected molecular alterations.
Masking: None (Open Label)
Masking Description:
no masking is used. All involved know the identity of the intervention assignment
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE Drug: Arm 1 - atezolizumab
Module 1 - 1200mg, IV, every 3 weeks, until progression or unacceptable toxicity develops.
Study Arms  ICMJE Experimental: Module 1 Arm 1 - atezolizumab

Genomically selected populations will all receive the same drug (6 groups of mutation will be evaluated)

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

Subjects will be recruited and allocated to arms according to their biomarker profile. It is assumed that 1000 subjects will need to be screened in part A in order to enroll 100 patients in part B of module 1.

Intervention: Drug: Arm 1 - atezolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xenia Villalobos Alberú, PhD +34 932 543 450 ext 8625 xvillalobos@vhio.net
Contact: Susana Muñoz +34 934 893 000 ext 2432 smunoz@vhio.net
Listed Location Countries  ICMJE France,   Germany,   Netherlands,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03767075
Other Study ID Numbers  ICMJE VHIO17002
2017-005108-89 ( EudraCT Number )
MO39164 ( Other Identifier: Roche Internal Identifier )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vall d'Hebron Institute of Oncology
Study Sponsor  ICMJE Vall d'Hebron Institute of Oncology
Collaborators  ICMJE
  • Roche Pharma AG
  • Iqvia Pty Ltd
Investigators  ICMJE
Study Chair: Jordi Rodon, MD MD Anderson
PRS Account Vall d'Hebron Institute of Oncology
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP