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

Recruiting now · Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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).

Key facts

Study ID: NCT03767075
Run by: Vall d'Hebron Institute of Oncology
People needed: 1000
Starts: 2018-12-10
Expected to finish: 2026-11-01
Last updated by the study team: 2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must have 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.
Patient must have ECOG performance status of 0 or 1.
Subjects must be 18-year-old or older.
Subjects must have measurable disease according to RECIST 1.1.
Subjects must have enough tumour tissue for molecular analysis.
Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 28 to 36 slides depending on the sample tumour cellularity. If there is not enough archival tissue to meet this criterion, the patient must undergo a tumour biopsy.
Subjects providing fresh frozen tissue must provide 5 core biopsies or equivalent.
Fresh frozen tissue must be preferentially collected from a tumour biopsy; hence, subjects must have disease amenable to be biopsied. Otherwise, the patient should have fresh frozen tumour tissue stored in a biobank or biorepository.
Efforts will be made to provide fresh frozen tissue in at least one quarter of the participating subjects. The proportion of subjects 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, subjects providing fresh frozen tissue from a recent biopsy will have part of the sample processed in FFPE as per Laboratory manual.
Subjects must have adequate haematological, renal, and hepatic function.
For subjects requiring a tumour biopsy: subjects must have adequate coagulation function.
Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.

You may not qualify if…

Subjects with leptomeningeal disease should be excluded from this clinical trial.
Subjects with known unstable brain metastases should be excluded from this clinical trial. Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.
Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
Subjects with 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.
Subjects with inability to swallow tablets or capsules.
Subjects with known HIV, hepatitis B or hepatitis C infection.
Subjects with known history of malabsorption.
Eligibilty Criteria (PART B - iBASKET)
Inclusion Criteria:
Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or for which standard therapy does not exist, or subjects may be unable to receive standard therapy.
Patient must have ECOG performance status of 0 or 1.
Subjects must be 18-year-old or older.
Subjects must have measurable disease according to RECIST 1.1.
Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
Tumours must harbour the following alterations.
Subjects must have adequate hematological, renal, and hepatic function.
For subjects requiring a tumour biopsy: subjects must have adequate coagulation function.
A woman of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy test during the study.
A woman must be either of the following:
Not of childbearing potential.
Of childbearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given.
Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method. Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
Ability to understand and the willingness to sign a written informed consent document.

Where it is running

Institut Gustave Roussy — Villejuif, France (enrolling)
Deutsches Krebsforschungszentrum (NCT/DKFZ) — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
Universitätsklinikum Dresden — Dresden, Germany (enrolling)
Instituto Nazionale dei Tumori di Milano — Milan, Italy (enrolling)
Nederland Kanker Instituut (NKI) — Amsterdam, Netherlands (enrolling)
Hospital Vall d'Hebron — Barcelona, Spain (enrolling)
Karolinska University Hospital Solna — Stockholm, Sweden (enrolling)
Cancer Research UK Cambridge Centre — Cambridge, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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