Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rear… (NCT05174650) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements
Germany27 participantsStarted 2022-04-20
Plain-language summary
The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Fully informed written consent and locally required authorization (European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
✓. Patients\*, age ≥ 18 years at the time of signing the Informed Consent Form.
✓. Histologically documented diagnosis of non-resectable iCCA with positively confirmed FGFR2 fusion/rearrangement via NGS-Analysis.
✓. Performance status (PS) ≤ 2 (ECOG scale).
✓. At maximum one previous line of systemic anti-cancer therapy, (chemotherapy, hormonal, targeted therapy, experimental therapy) for which treatment was discontinued at least 4 weeks before the first dose of study treatment, or five half-lives of the respective anti-cancer therapy, whichever is the longer period.
✓. No prior treatment with any FGFR or immune checkpoint inhibitor (including but not limited to antiCTLA-4, antiPD-1, and antiPD-L1 therapeutic antibodies) apart from Durvalumab as PD-L1 inhibitor in first line therapy.
✓. Body weight \> 30 kg AND BMI ≥ 15.
✓. At least one measurable site of disease as defined by RECIST 1.1 criteria.
Exclusion criteria
✕. Mixed cholangiocarcinoma and HCC.
✕. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) study or a study without a medical intervention (specifically the PLATON registry \[ClinicalTrials.gov identifier: NCT04484636\] is allowed).
What they're measuring
1
Primary Objective: Assessment of Efficacy
Timeframe: up to 4 years, at EOS
Trial details
NCT IDNCT05174650
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
✕. Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery.
✕. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious active, uncontrolled, gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
✕. History of another primary malignancy except for:
✕. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 5 months after the last dose of combination therapy or for a period of at least 5 half-lives of the respective drug/IMP after the last dose of combination therapy (whichever is longer).
✕. Known allergy or hypersensitivity to any of the IMPs or any of the constituents of the product.
✕. Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.