Klinische Studie
A randomized, open-label, Phase 2/3 trial of izalontamab brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment(IZABRIGHT-Bladder01)Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase II/III
StudientypInterventionsstudiePhase II/III
Wesentliche Einschlusskriterien1) Histologically or cytologically documented metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder, or urethra. Minor histologic variants (ie, < 50% overall) are acceptable, provided that TCC is the dominant histology.
2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
3) Participants must have disease progression or recurrence on or following treatment with anti programmed cell death protein 1/programmed death-ligand 1 (anti-PD-(L)1)-based therapy), either in combination with or sequential to another systemic therapy (eg, PBC, ADC).
Note: Anti PD-1/PD-L1 therapy administered in a locally advanced or metastatic setting (eg, adjuvant, peri-operative, 1L, 1L maintenance, or 2L), will be considered towards eligibility for the study.
Note: The anti-PD-(L)1-based regimen does not have to be the most recent line of therapy.
Note: Participants who have received anti-PD-(L)1 therapy only in the NMIBC setting are ineligible.
Note: All participants progressing on or after completion of peri-operative treatment are considered to have received 1 prior regimen of therapy. Following disease progression on or after perioperative therapy, further treatment in the advanced disease setting would qualify as a second regimen of therapy even if it is the same treatment used perioperatively. Additionally,
switch maintenance therapy with PD-(L)1 inhibitors for advanced disease and switch in therapy due to safety or toxicity reasons unrelated to disease progression are not regarded as additional regimens of therapy.
4) Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of treatment.
5) Participants must be eligible for a PBC regimen with cisplatin or carboplatin.
a) Patients must have a platinum-free interval of at least 12 months from the last dose of prior PBC.
b) Patients with progressive disease (PD) or with stable disease (SD) of less than 6-months duration as best overall response on prior platinum-based chemotherapy are ineligible.
Wesentliche Ausschlusskriterien1) Participants with untreated CNS (eg, brain or leptomeningeal) metastases or spinal cord compression.
Note: Participants are eligible if CNS metastases have been definitively treated and are clinically stable or have returned to baseline (except for residual effects from treatment).
Note: Participants must have discontinued corticosteroids or be on a stable/decreasing dose of 10 mg or less of prednisone (or equivalent) daily for at least 2 weeks before initiating treatment.
Note: Baseline imaging required at screening must be performed at least 28 days after definitive treatment for CNS metastases is completed. CNS metastases must be radiographically stable.
2) Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment (ie, participants with a history or prior malignancy are eligible if treatment is completed at least 2 years before treatment assignment and there is no evidence of disease). Participants with a history of prior early-stage
cancer including basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible if the condition would not confound study results.
3) History of severe heart disease including, but not limited to, any of the following:
a) History of clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification II to IV, or significant pericardial effusion) within 6 months prior to randomization.
b) Myocardial infarction, uncontrolled angina, or stroke/transient ischemic attack within 6 months prior to randomization.
c) QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation ≥ 450 msec for males and ≥ 470 msec for females, except for right bundle branch block (RBBB).
4) Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism, within 2 months prior to screening. Infusion set-related thrombosis is permissible. Participants receiving treatment for a thrombotic event, regardless of etiology, need to be on a stable dose of anticoagulant to be eligible and must have tolerated treatment without clinically significant bleeding or other major sequelae.
5) Participants with known coagulation disorders, including hemophilia, von Willebrand disease, or any other coagulation disorders, that may affect blood clotting.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de