Transplant and Hepato-Pancreato-Biliary (HPB) Institute

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   Transplant and Hepato-Pancreato-Biliary (HPB) Institute

Clinical Trials

For some patients, traditional treatment methods may be supplemented with participation in a clinical trial. A clinical trial can possible allow you to receive therapies such as immunotherapy and cancer vaccines that are in the development process. Below is a sampling of the unique clinical trials we have available to you. Feel free to contact us to identify whether you qualify and would like to participate.

  • Pancreatic Cancers
    3.080: Phase 1b/2 trial of the NANT Pancreatic Cancer Vaccine as treatment for subjects with pancreatic cancer who have progressed on or after standard-of-care therapy [NCT pending]
    Main Inclusion Criteria:
    • Histologically-confirmed pancreatic adenocarcinoma with progression on or after standard of care therapy
    • Have at least 1 measurable lesion of ≥ 1.0 cm
    DIPLOMA: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy

    Main Inclusion Criteria: confirmed or suspected pancreatic adenocarcinoma in the neck, body, or tail of the pancreas

    2.025: NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using A Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects With Previously Treated Cancer [NCT03552718]
    Main Eligibility Criteria:
    • Histologically-confirmed solid cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
    • Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple- negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.
    3.013: Phase I Study Of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) In Subjects With Unresectable Locally Advanced Or Metastatic HER2- Expressing (IHC 1+/2+/3+) Cancer [NCT02751528]
    Main Eligibility Criteria:
    • Histologically confirmed unresectable locally advanced or metastatic cancer that expresses HER2 (IHC 1+, 2+, or 3+), derived from the most recent metastatic biopsy sample available.
    • Concurrent hormone therapy is permitted.
    • Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
    • Subjects cannot have ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
    • Subjects cannot have concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
    3.014: A Phase I Trial Of ABI-011 Administered Weekly In Patients With Advanced Solid Tumors Or Lymphomas [NCT02582827]
    Main Inclusion Criteria:
    • Cytologically or histologically-confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
    • During the dose-escalation phase, measurable or non-measurable disease as defined by RECIST criteria Version 1.1.
    3.028: Open-Label, Phase 1 Study Of HaNKTM For Infusion In Subjects With Metastatic Or Locally Advanced Solid Tumors [NCT03027128]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy.
    • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
    • Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed.
    3.036: A Phase 2 Study Of AMG 337 In Subjects With Advanced Or Metastatic Solid Tumors That Overexpress MET Or Harbor MET Exon 14 Skipping (METex14del) Mutations [NCT03147976]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable locally advanced or metastatic solid tumor that overexpresses tumor MET (MET protein expression ≥ 1,000 attomole/μg of tumor tissue, as determined by quantitative proteomics with mass spectrometry [cohort 1]) or harbor METex14del mutations resulting in MET exon 14 skipping (as determined by DNA sequencing and confirmed with RNA sequencing [cohort 2]).
    • Have measurable disease evaluable in accordance with RECIST Version 1.1.
  • Liver Cancers
    3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-Affinity Natural Killer (haNK) Cell Therapy with Adenoviral and Yeast-Based Vaccines to Induce T-Cell Responses in Subjects with Advanced, Unresectable, and Untransplantable HCC [NCT03563170]
    Main Inclusion Criteria:
    • Histologically-confirmed advanced, unresectable and untransplantable HCC
    • Have at least 1 measurable lesion of ≥ 1.0 cm
    • Child-Pugh class A only
    2.025: NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine to Induce T-Cell Responses in Subjects with Previously Treated Cancer [NCT03552718]
    Main Eligibility Criteria:
    • Histologically-confirmed solid cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
    • Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple- negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.
    3.013: Phase I Study of Ad5 [E1-, E2b-]-HER2/neu Vaccine (ETBX-021) in Subjects with Unresectable Locally Advanced or Metastatic HER2- Expressing (IHC 1+/2+/3+) Cancer [NCT02751528]
    Main Eligibility Criteria:
    • Histologically confirmed unresectable locally advanced or metastatic cancer that expresses HER2 (IHC 1+, 2+, or 3+), derived from the most recent metastatic biopsy sample available.
    • Concurrent hormone therapy is permitted.
    • Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
    • Subjects cannot have ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
    • Subjects cannot have concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
    3.014: A Phase I Trial of ABI-011 Administered Weekly in Patients with Advanced Solid Tumors or Lymphomas [NCT02582827]
    Main Inclusion Criteria:
    • Cytologically or histologically-confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
    • During the dose-escalation phase, measurable or non-measurable disease as defined by RECIST criteria Version 1.1.
    3.028: Open-label, Phase 1 Study of haNKTM for Infusion in Subjects with Metastatic or Locally Advanced Solid Tumors [NCT03027128]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy.
    • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
    • Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed.
    3.036: A Phase 2 Study of AMG 337 in Subjects with Advanced or Metastatic Solid Tumors That Overexpress MET or Harbor MET Exon 14 Skipping (METex14del) Mutations [NCT03147976]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable locally advanced or metastatic solid tumor that overexpresses tumor MET (MET protein expression ≥ 1,000 attomole/μg of tumor tissue, as determined by quantitative proteomics with mass spectrometry [cohort 1]) or harbor METex14del mutations resulting in MET exon 14 skipping (as determined by DNA sequencing and confirmed with RNA sequencing [cohort 2]).
    • Have measurable disease evaluable in accordance with RECIST Version 1.1.
  • Biliary/Gallbladder Cancers
    2.025: NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using A Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects With Previously Treated Cancer [NCT03552718]
    Main Eligibility Criteria:
    • Histologically-confirmed solid cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
    • Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple- negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.
    3.013: Phase I Study Of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) In Subjects With Unresectable Locally Advanced Or Metastatic HER2- Expressing (IHC 1+/2+/3+) Cancer [NCT02751528]
    Main Eligibility Criteria:
    • Histologically confirmed unresectable locally advanced or metastatic cancer that expresses HER2 (IHC 1+, 2+, or 3+), derived from the most recent metastatic biopsy sample available.
    • Concurrent hormone therapy is permitted.
    • Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
    • Subjects cannot have ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
    • Subjects cannot have concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
    3.014: A Phase I Trial Of ABI-011 Administered Weekly In Patients With Advanced Solid Tumors Or Lymphomas [NCT02582827]
    Main Inclusion Criteria:
    • Cytologically or histologically-confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
    • During the dose-escalation phase, measurable or non-measurable disease as defined by RECIST criteria Version 1.1.
    3.028: Open-Label, Phase 1 Study Of HaNKTM For Infusion In Subjects With Metastatic Or Locally Advanced Solid Tumors [NCT03027128]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy.
    • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
    • Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed.
    3.036: A Phase 2 Study Of AMG 337 In Subjects With Advanced Or Metastatic Solid Tumors That Overexpress MET Or Harbor MET Exon 14 Skipping (METex14del) Mutations [NCT03147976]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable locally advanced or metastatic solid tumor that overexpresses tumor MET (MET protein expression ≥ 1,000 attomole/μg of tumor tissue, as determined by quantitative proteomics with mass spectrometry [cohort 1]) or harbor METex14del mutations resulting in MET exon 14 skipping (as determined by DNA sequencing and confirmed with RNA sequencing [cohort 2]).
    • Have measurable disease evaluable in accordance with RECIST Version 1.1.
  • Colorectal Cancers
    3.071: NANT COLORECTAL CANCER (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine Vs Regorafenib in Subjects with Metastatic CRC Who Have Been Previously Treated with Standard-of-Care Therapy [NCT03563157]
    Main Inclusion Criteria:
    • Histologically-confirmed recurrent or metastatic CRC previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy; or subjects who are ineligible for these therapies
    • Have at least 1 measurable lesion of ≥ 1.0 cm
    2.025: NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using A Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects With Previously Treated Cancer [NCT03552718]
    Main Eligibility Criteria:
    • Histologically-confirmed solid cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
    • Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple- negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.
    3.013: Phase I Study Of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) In Subjects With Unresectable Locally Advanced Or Metastatic HER2- Expressing (IHC 1+/2+/3+) Cancer [NCT02751528]
    Main Eligibility Criteria:
    • Histologically confirmed unresectable locally advanced or metastatic cancer that expresses HER2 (IHC 1+, 2+, or 3+), derived from the most recent metastatic biopsy sample available.
    • Concurrent hormone therapy is permitted.
    • Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
    • Subjects cannot have ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
    • Subjects cannot have concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
    3.014: A Phase I Trial Of ABI-011 Administered Weekly In Patients With Advanced Solid Tumors Or Lymphomas [NCT02582827]
    Main Inclusion Criteria:
    • Cytologically or histologically-confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
    • During the dose-escalation phase, measurable or non-measurable disease as defined by RECIST criteria Version 1.1.
    3.028: Open-Label, Phase 1 Study Of HaNKTM For Infusion In Subjects With Metastatic Or Locally Advanced Solid Tumors [NCT03027128]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable, locally advanced or metastatic solid malignancy.
    • Have at least 1 measurable lesion and/or non-measurable disease evaluable according to RECIST Version 1.1.
    • Have received treatment with at least 1 prior line of therapy in the metastatic setting or not be a candidate for therapy of proven efficacy for their disease. Prior immune therapy is allowed.
    3.036: A Phase 2 Study Of AMG 337 In Subjects With Advanced Or Metastatic Solid Tumors That Overexpress MET Or Harbor MET Exon 14 Skipping (METex14del) Mutations [NCT03147976]
    Main Inclusion Criteria:
    • Histologically confirmed, unresectable locally advanced or metastatic solid tumor that overexpresses tumor MET (MET protein expression ≥ 1,000 attomole/μg of tumor tissue, as determined by quantitative proteomics with mass spectrometry [cohort 1]) or harbor METex14del mutations resulting in MET exon 14 skipping (as determined by DNA sequencing and confirmed with RNA sequencing [cohort 2]).
    • Have measurable disease evaluable in accordance with RECIST Version 1.1.
  • Non-Therapeutic Clinical Trials
    Repository for Human Biological Materials and Clinical Data for Cancer Research
    Main Inclusion Criteria:
    • Histologically confirmed malignancy
    Repository for Clinical Data and the Collection of Liver, Biliary and Pancreatic Tissue/Fluid, Blood and Bile for Hepatopancreatobiliary and Transplant Research
    Main Inclusion Criteria:
    • Disorder of the liver, biliary tract, pancreas or associated tissues