J19108 - A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without M7824 (bintrafusp alfa) as First-line Treatment of Biliary Tract Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
To assess bintrafusp alfa (M7824) in combination with gemcitabine plus cisplatin versus placebo with gemcitabine plus cisplatin in participants with advanced or metastatic biliary tract cancer who have not received chemotherapy/immunotherapy in the advanced/metastatic setting.
Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), including but not limited to anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody, or anti-4-1BB antibody is not allowed, inclusive of localized administration of such agents. Prior therapy with any antibody/drug targeting TGFß/TGFß receptor is not allowed. Participants who have completed prior adjuvant therapy greater than 6 months prior to randomization are eligible.Patients with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are not allowed. Patients cannot require steroids greater than 10mg of prednisone per day to treat conditions such as autoimmune diseases.Patients with active infections, organ transplants, Tuberculosis, HIV/ AIDS, interstitial lung disease or its history may not be enrolled.Recent history with less than 6 months from enrollment, patients cannot have had a stroke or myocardial infarction. Unstable angina, congestive heart failure, or serious cardiac arrhythmia will not be enrolled.Patients who are pregnant or breastfeeding may not enroll.
One cycle of treatment lasts 21 days. Patients will receive M7824 (IV)/or placebo once every 3 weeks. For the first 8 cycles, patients will receive Gemcitabine and Cisplatin on Days 1 and 8 of each cycle. Patients will be treated until confirmed progression of disease, unacceptable toxicity, study withdrawal, or up to 43 weeks (14 cycles).
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