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10476 / A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the response rate (ORR) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib, and to assess the progression free survival (PFS) of patients with unresectable, pre-treated biliary cancers treated with the combination of atezolizumab and CDX-1127 (varlilumab) with or without cobimetinib.
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A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206)
Rochester, Minn.
The purpose of this trial is to evaluate the effectiveness and safety of TT-00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment and discontinued due to disease progression, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.
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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (SKYSCRAPER-14)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1) (EMERALD-1)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this global study is to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma.
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An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD-1) in Combination with Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) or Sym023 and Irinotecan in Patients with Recurrent Advanced Biliary Tract Carcinomas
Rochester, Minn.
The purpose of this study is to evaluate the preliminary effectiveness of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym023+Irinotecan) in Biliary Tract Cancer by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. This study will also evaluate the safety and tolerability profile of the 3 combinations (Sym021+Sym022 and Sym021+Sym023 and Sym023+Irinotecan).
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An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as monotherapy and in combination with Nivolumab for Treatment of Patients with Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary objectie of Safety Run-In Cohort (Cohort 1) is to evaluate the safety and tolerability of multiple intratumoral injections (IT) of VG161 at the recommendated Phase 2 Dose (RP2D) in patients with HCC and ICC who have either disease progression or intolerable toxicity after the standard treatments.
The primary objective of HCC Cohort (Cohort 2) is to evaluate the efficacy of multiple IT injections of VG161 in patients with hepatocellular carcinoma (HCC).
The primary objective of ICC Cohort (Cohort 3) is to evaluate the efficacy of multiple IT injections of VG161 in patients with intrahepatic cholangiocarcinoma.
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S1815, A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers
Rochester, Minn.,
La Crosse, Wis.,
Eau Claire, Wis.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
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SGNTUC-019 - A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant. The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.
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