Actively Recruiting
A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
Led by Vall d'Hebron Institute of Oncology · Updated on 2024-04-25
1000
Participants Needed
8
Research Sites
411 weeks
Total Duration
On this page
Sponsors
V
Vall d'Hebron Institute of Oncology
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of atezolizumab in each of the arms of the module. All patients in genomically selected populations will receive atezolizumab 1200 mg IV every 3 weeks. The objective of module 2 wil be to determine the overall response rate (ORR) at 16 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of futibatinib in each of the arms of the module. All patients in genomically selected populations will receive will receive futibatinib, 20 mg, once daily (QD) in 28-day cycles. The objective of module 3 wil be to determine the overall response rate (ORR) at 12 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of amivantamab in each of the arms of the module. All patients in genomically selected populations will receive amivantamab 1050 mg intravenously (IV) for body weight \< 80 kg and 1400 mg for body weight \>= 80 kg mg once weekly in Cycle 1 (with a split dose on Days 1-2) and then every 2 weeks in subsequent cycles (28-day cycles).
CONDITIONS
Official Title
A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed metastatic or unresectable malignancy that has progressed after standard therapy or has no standard therapy available
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST 1.1
- Sufficient tumor tissue available for molecular analysis via biopsy or archival samples
- Adequate hematological, renal, and hepatic function
- Adequate coagulation function if tumor biopsy is required
- Willingness to participate in a clinical trial with matched therapy based on tumor molecular profile
- For women of childbearing potential: negative pregnancy test within 72 hours before treatment start and agreement to use effective contraception or true abstinence during and for 6 months after treatment
- Women must agree not to donate eggs during the study and for 6 months after last dose
- Men must agree not to donate sperm during the study and for 6 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of leptomeningeal disease
- Unstable brain metastases or symptomatic brain metastases not treated or stable for less than 6 months
- Untreated spinal cord compression
- Uncontrolled illnesses such as active infection, congestive heart failure, low left ventricular ejection fraction, unstable angina, cardiac arrhythmia, or psychiatric/social issues affecting compliance
- Inability to swallow tablets or capsules
- Known HIV, hepatitis B or C infection
- History of malabsorption
- Pregnancy or breastfeeding
- Receipt of anticancer therapy or investigational agents within 3 weeks prior to study treatment initiation (with some exceptions)
- Recent major surgery or invasive procedure within 15 days before first dose
- Unstable symptomatic brain metastases
- Meningeal or leptomeningeal carcinomatosis
- Significant cardiovascular disease such as severe heart failure, recent myocardial infarction, unstable angina, or arrhythmias
- Another primary malignancy within 2 years unless low risk of relapse
- Contraindications listed in the product information of study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
2
Deutsches Krebsforschungszentrum (NCT/DKFZ)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
3
Universitätsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
4
Instituto Nazionale dei Tumori di Milano
Milan, Italy, 20133
Actively Recruiting
5
Nederland Kanker Instituut (NKI)
Amsterdam, Netherlands, 1066
Actively Recruiting
6
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
7
Karolinska University Hospital Solna
Stockholm, Sweden, 17176
Actively Recruiting
8
Cancer Research UK Cambridge Centre
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
M
Marta Carboneras
CONTACT
S
Susana Muñoz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here