The FUTURE trial is a prospective, multicentre, exploratory, open-label phase II platform trial. Its goal is to evaluate the efficacy, feasibility and safety of futibatinib combined with immunotherapeutic, targeted or chemotherapeutic agents in colorectal and other solid tumors and to additionally identify biomarkers that correlate with clinical outcome.
Patient* provides signed informed consent.
Patient is ≥ 18 years at the time of given informed consent.
Specific for FUTURE-001: Patient must agree to participation in the accompanying translational research program.
Specific for FUTURE-001: Patient did not receive previous therapy in palliative setting (1st line situation).
Specific for FUTURE-001: Patient has curative colorectal cancer.
Patient received previous FGFR-addressed therapy with an FGFR inhibitor.
Patient has known presence of tumors other than the entity investigated in the respective cohort (FUTURE-001: colorectal cancer) or a secondary tumor other than squamous or basal cell carcinomas of the skin or in situ carcinomas of the cervix which have been effectively treated. The sponsor decides to include patients who have received curative treatment and have been disease-free for at least 5 years
Patient has known untreated or symptomatic CNS or leptomeningeal metastases.
Single group
Futibatinib orally administered
DrugFutibatinib will be administered 20mg orally, once daily, continously
Tislelizumab (i.v. 200mg)
DrugTislelizumab (i.v. 200mg) will be administered on day 1 and day 22 of a 6-week cycle
Overall Response Rate (ORR) according to RECIST v1.1
ORR, defined as rate of patient who achieved complete or partial response (CR+PR) according to RECIST v1.1 as best response
Duration of Response (DoR)
(DoR), defined as time from response initiation (when either CR or PR is first determined) to date of progression or death to any cause
Progression-free survival (PFS) according to RECIST v1.1
defined as time from date of enrollment to date of progression acc. to RECIST v1.1 or death due to any cause
Overall Survival (OS)
time from date of enrollment date of death due to any cause
Safety
assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0
Identifcation of molecular biomarkers
to perform correlation analysis between selected molecular parameters and clinical data to identify molecular biomarkers predictive for clinical outcome
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Universitätsmedizin Mainz, I. Medizinische Klinik, Forschungslabor Prof. Möhler
Collaborator
