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Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC
Protocol Number: 001720
Phase: N/A
Scope: National
Applicable Disease Sites: Liver
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Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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Primary Objective: Phase I: (1) To determine the safety and tolerability and recommended phase 2 dose (RP2D) of M3814 in combination with hypofractionated radiation and avelumab in patients with advanced/metastatic solid tumors. Phase II: (1) To determine the efficacy of the combination of hypofractionated radiation, M3814, and avelumab as compared to the combination of hypofractionated radiation and avelumab in patients with advanced/metastatic hepatobiliary tumors by objective response rate (ORR) in non-irradiated lesions. All lesions (target and non-target) except the one or two lesions that were irradiated are to be included in the assessment of overall response using RECIST v1.1. Secondary Objective(s): Phase I: (1) To observe and record anti-tumor activity. Although the clinical benefit of this combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Specifically, to determine efficacy of the combination by measurement of disease control rate (DCR), duration of response (DOR), progression free survival (PFS), PFS outside the irradiated field, and overall survival (OS) in patients with advanced/metastatic solid tumors. (2) To characterize the pharmacokinetic (PK) profile of M3814 in combination with avelumab. Phase II: (1) To determine the efficacy and safety of the combination of hypofractionated radiation, M3814, and avelumab as compared to hypofractionated radiation and avelumab by measurement of DCR, DOR, PFS, PFS outside the irradiated field, and OS in patients with advanced/metastatic hepatobiliary tumors. (2) To determine if baseline DNA repair defects inherent to some cholangiocarcinomas correlate with a more dramatic response to radiation compared to those without as measured by H2AX pNBS1 multiplex IFA assay. (3) To characterize the pharmacokinetic (PK) profiles of M3814 and avelumab.
Protocol Number: 052002
Principal Investigator: Salma Jabbour
Phase: Phase I/II
Applicable Disease Sites: Any Site, Liver, Other Digestive Organ
Therapies Involved: Chemotherapy multiple agents systemic Chemotherapy single agent systemic Radiotherapy
Drugs Involved: Avelumab M3814
The objectives of the study are to: To investigate the confirmed objective response rate (ORR) of nivolumab and ipilimumab in patients with hepatocellular carcinoma (HCC) who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To determine the overall survival (OS) in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment . To determine the progression free survival (PFS) in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To determine the disease control rate in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment. To assess the frequency and severity of adverse events in hepatocellular carcinoma (HCC) patients treated with nivolumab and ipilimumab who have progressed radiographically on atezolizumab/bevacizumab that necessitates change in treatment.
Protocol Number: 072213
Principal Investigator: Sharon Li
Therapies Involved: Chemotherapy multiple agents systemic
Drugs Involved: IPILIMUMAB (MDX-010) Opdivo (Nivolumab)
Primary Objective: To determine if consolidation therapy with Tislelizumab following local therapy improves 1-year progression-free survival in patients with locally advanced, unresectable HCC. PFS is defined as the time from registration until the criteria for disease progression is met by mRECIST and RECIST v1.1 or death as a result of any cause. Secondary Objectives: 1.To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) and local control in subjects with localized, inoperable HCC. 2.To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable HCC. 3.To assess the safety profile of Tislelizumab after definitive therapy. 4. To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient s tumor produce AFP. Exploratory Objectives: 1.To determine the strength by which the tumor molecular profile from NGS tissue prior to initiation of therapy correlates with treatment response. 2.To analyze ctDNA as a biomarker of response to therapy and early detection of disease progression.
Protocol Number: 072105
Phase: Phase II
Scope: Local
Therapies Involved: Chemotherapy single agent systemic
Drugs Involved: Tislelizumab (BGB-A317)
Primary objective: - To evaluate the safety of the study treatments in Cohorts A and B. Secondary Objectives: - To evaluate the efficacy of the study treatments in Cohorts A and B. - To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participants perspective. Exploratory Objectives: To identify biomarkers as follows: - Those associated with response to atezolizumab + bevacizumab or atezolizumab monotherapy. - Those that are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers). OR - Those that can increase the knowledge of disease biology and drug safety in Cohorts A and B.
Protocol Number: 072309
Principal Investigator: Howard Hochster
Therapies Involved: Chemotherapy multiple agents systemic Chemotherapy single agent systemic
Drugs Involved: Atezolizumab (MPDL3280A) BEVACIZUMAB
Primary: - To assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab by assessment of PFS in participants with unresectable HCC amenable to locoregional therapy Secondary: - To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess ORR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess OS after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess DoR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy Exploratory: - To further assess the pattern of progressive disease after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To describe tumor and normal tissue absorbed radioembolization dose and its relationship with response and outcomes and liver volume changes after treatment. - To assess participant-reported diseaseand treatment-related symptoms and HRQoL in participants with unresectable HCC amenable to locoregional therapy
Protocol Number: 072311
Drugs Involved: BEVACIZUMAB MEDI4736 (Durvalumab)