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  • (ECTx) TG4050.01; A phase I trial evaluating a mutanome-directed immunotherapy in patients with high grade serous carcinoma (HGSC) of the ovary, fallopian tube or peritoneum who experience an asymptomatic relapse Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the safety and tolerability, as well as some activity parameters, of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.

  • A Phase Ib/II Trial Evaluating the Combination of TG4001 and Avelumab in Patients With HPV-16 Positive Recurrent or Metastatic Malignancies Jacksonville, Fla., Rochester, Minn.

    The study will consist of two parts. The purpose of Phase Ib is to evaluate the safety and tolerability of the combination of TG4001 plus avelumab in patients with recurrent or metastatic HPV-16 positive advanced malignancies. The purpose of Phase II part 1 is to evaluate the effectiveness of TG4001 combined to avelumab in terms of Overall Response Rate (ORR) by using RECIST 1.1 in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies including oropharyngeal SCCHN. The purpose of Phase II part 2 is to compare the Progression-Free Survival (PFS) of TG4001 in combination with avelumab vs avelumab alone in patients with recurrent or metastatic (R/M) HPV-16 positive advanced malignancies and without liver metastases at baseline. PFS will be evaluated based on RECIST 1.1. 

    In the phase Ib: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG4001 in combination with avelumab according to a 3+3 design. There will be no intra-patient dose escalation. In the phase II part 1, evaluation of efficacy and further evaluation of safety of the combination of TG4001 and avelumab will be performed in a single arm of patients with recurrent or metastatic HPV-16 positive advanced malignancies. In the phase II part 2, evaluation of effectiveness of the combination of TG4001 and avelumab will be performed in a randomized, open-label controlled study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV-16 positive advanced malignancies. In both phases, tumor response will be evaluated on local assessment using RECIST 1.1. All patients will be followed up until disease progression, death, or unacceptable toxicity, or study withdrawal for any reason, whichever occurs first. 

    Mayo Clinic will only be participating in the Phase II part 2 portion of the study.

  • Longitudinal Changes in Blood Components in Patients with Ovarian Cancer Rochester, Minn.

    The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.

  • MC1371: Targeted Complex Therapy for Advanced Melanoma, Gynecologic Cancers, and Other Malignancies: Nab-paclitaxel (Abraxane)/Bevacizumab Complex (AB-Complex) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab may kill more tumor cells.

  • MC1376 Phase I Trial to Evaluate the Safety and Efficacy of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients with Metastatic Ocular Melanoma and Previously Treated Patients with Unresectable Stage III/IV Cutaneous Melanoma Rochester, Minn.

    The purpose of this study is to determine the safety profile and maximum tolerated dose (MTD) of VSV-IFNß-TYRP1 therapy when administered by IV and IT injection in patients with previously treated metastatic melanoma.

  • MC1577: Phase I Study of Pembrolizumab in Combination with Ibrutinib in the Treatment of Unresectable or Metastatic Melanoma Rochester, Minn.

    This phase II trial studies how well pembrolizumab and ibrutinib work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ibrutinib may work better in treating patients with melanoma.

  • MC1776 Neoadjuvant Therapy for Patients With High Risk Stage III Melanoma: A Pilot Clinical Trial (NeoACTIVATE) Rochester, Minn., Jacksonville, Fla.

    The purpose of this early phase I pilot trial studies how well vemurafenib, cobimetinib, and atezolizumab work in treating participants with high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving vemurafenib, cobimetinib, and atezolizumab may work better in treating high-risk stage III melanoma.

    A third cohort of patients (Arm C) will receive tiragolumab and atezolizumab for neoadjuvant therapy, and atezolizumab alone for adjuvant therapy.

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