Closed for Enrollment

• A Multi-Institutional Phase 2 Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

  The purpose of this study is to determine how well nivolumab, with or without ipilimumab, works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). 

• A Phase 2 Study of Durvalumab and Tremelimumab Alone or in Combination With High or Low-Dose Radiation in Metastatic Colorectal and NSCLC Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread to other parts of the body. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving durvalumab and tremelimumab with radiation therapy may work better in treating patients with colorectal or non-small cell lung cancer.

• A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy Scottsdale/Phoenix, Ariz., Rochester, Minn.

  The purpose of this study is to assess the effectiveness of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

• A Phase 2, Open-Label, Randomized, Non-Comparative Study With Preliminary Dose Finding to Evaluate eFT508 Monotherapy or eFT508 in Combination With Avelumab in Subjects With Microsatellite Stable Relapsed or Refractory Colorectal Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.

• A Phase I Clinical Study of BBI503 in Adult Patients With Advanced Solid Tumors Scottsdale/Phoenix, Ariz., Rochester, Minn.

  This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors.

• A Phase Ia/Ib Clinical Trial of PRI-724 in Patients With Advanced Solid Tumors Rochester, Minn., Scottsdale/Phoenix, Ariz.

  PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced solid tumors. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread(metastasize).

  Phase Ia: Patient cohorts with solid tumor malignancies will be treated with escalating doses (per cohort) of PRI-724 in order to identify the MTD of this single-agent regimen. PRI-724 dosing is to start at 40 mg/m2/day, CIV infusion over 24 hours × 7 days.

  Phase Ib: This phase is to begin upon identification of the MTD in Phase 1a. Patient cohorts with CRC will be treated with escalating doses (per cohort) of PRI-724 administered in combination with a modified regimen of FOLFOX6 (mFOLFOX 6, standardized doses and schedule) in order to identify the MTD of this combined regimen. Up to 2 dose levels of PRI-724 are to be examined (640 and 905 mg/m2/day, CIV infusion over 24 hours × 7 days), with potential to evaluate a previously unexamined intermediate dose, if indicated, to more fully characterize tolerability. The MTD cohort (or maximum dose to be studied) will be expanded up to 12 patients.

• A Phase Ib Clinical Study of BBI608 in Combination with Standard Chemotherapies in Adult Patients with Advanced Gastrointestinal Cancer Scottsdale/Phoenix, Ariz., Rochester, Minn. This is an open label, multi-center, Phase Ib dose escalation study of BBI608 administered in combination with either FOLFOX6 with and without bevacizumab, or CAPOX, or FOLFIRI with and without bevacizumab, or regorafenib. A study cycle will consist of daily and continuous oral administration of BBI608 for four weeks (28 days) in combination with FOLFOX6 with and without bevacizumab, or CAPOX or FOLFIRI with and without bevacizumab, or regorafenib.
• A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177) Rochester, Minn., Scottsdale/Phoenix, Ariz.

  In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) or overall survival (OS) compared to current SOC chemotherapy.

• A Randomized, Double-blind, Placebo-Controlled Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer Rochester, Minn.

  The purpose of this research study is to see if cancer will respond better to a combination of irinotecan and cetuximab with or without bevacizumab

• BBI608-224: A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer Scottsdale/Phoenix, Ariz., Rochester, Minn. This is an open label study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.
• CanStem303C - A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC) (CanStem303C) Scottsdale/Phoenix, Ariz., Rochester, Minn.

  This is an international multi-center, prospective, open-label, randomized phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).

• Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies (ARCS-Multi) Scottsdale/Phoenix, Ariz., Rochester, Minn.

  The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarcinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for review and biomarkers.

• Phase I Trial of TAS-102 and Concurrent Radiation Therapy for Patients With Locally Recurrent, Unresectable or Metastatic, Rectal Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.

• PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (PRESERVE1) Rochester, Minn.

  This study aims to evaluate the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.

• Regorafenib Dose Optimization Study (ReDOS): A Phase II Randomized Study of Lower Dose Regorafenib Compared to Standard Dose Regorafenib in Patients With Refractory Metastatic Colorectal Cancer (mCRC) (ReDOS) Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This randomized phase II trial studies how well lower-dose compared to standard dose regorafenib works in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body and does not respond to treatment. Regorafenib may stop the growth of colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth and by blocking some of the enzymes needed for cell growth. It is not yet known whether lower-dose or standard dose regorafenib is more effective in treating patients with colorectal cancer. Clobetasol propionate is a steroid cream that is commonly used to treat a variety of skin conditions and may help prevent hand-foot skin reactions in patients receiving regorafenib.

• Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study Rochester, Minn.

  The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

• S4-13-001; A Phase I/II Study of CX-4945 in Combination With Gemcitabine and Cisplatin in the Frontline Treatment of Patients With Cholangiocarcinoma Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD), followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the combination MTD with gemcitabine plus cisplatin.

• Single Dose, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Subcutaneous Injection of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects With Metastatic Colorectal Cancer (CRC) (OBERTO) Rochester, Minn.

  TREOS' Phase I clinical trial will investigate the safety, tolerability, and immunogenicity of a single dose of PolyPEPI1018 CRC Vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. This study will also explore the accuracy of prediction of pre-existing and newly induced CD8+ T cell responses in each patient using the PEPI Test and T lymphocyte infiltration detected in accessible biopsy sites.