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  • Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway Altered Malignancies Solid Tumors

    The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies. NCT04566393 Click here for additional information.

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    Principal Investigator: Jose Galeas, MD

    Research Nurse: Wendy Blount, RN, MSN

  • A study to test whether different doses of BI 764532 help people with small cell lung cancer or other neuroendocrine cancers Neuroendocrine Cancer, Small Cell Lung Cancer

    DAREON™-5: An open-label, multi-center Phase II dose selection trial of intravenous BI 764532, a DLL3-targeting T cell engager, in patients with relapsed/refractory extensive-stage small cell lung cancer and in patients with other relapsed/refractory neuroendocrine carcinomas. Please click here for additional information about this study.

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    Principal Investigator: Jose Galeas, MD

    Research Nurse: Wendy Blount, RN, MSN

  • A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma Liver

    This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation). For more ...

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    Principal Investigator: Prajwol Pathak, M.D.

    Research Nurse: Wendy Blount, RN, MSN

  • A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera Polycythemia Vera

    This study is intended to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera in maintaining hematocrit control. Phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (PV) who require phlebotomy on a routine basis. There is a 32-week period during which rusfertide or placebo will be added-on to each subject's ...

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    Principal Investigator: Furhan Yunus, M.D.

    Research Nurse: Wendy Blount, RN, MSN

  • Optimice-Pcr: De-Escalation of Therapy in Early-Stage Tnbc Patients Who Achieve Pcr After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy Breast

    NCT05812807 Optimice-Pcr: De-Escalation of Therapy in Early-Stage Tnbc Patients Who Achieve Pcr After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative ...

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    Principal Investigator: Jose Galeas, MD

    Research Nurse: Wendy Blount, RN, MSN

  • Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer Breast

    NCT04457596 The Compassher2 Trial (Comprehensive Use of Pathologic Response Assessment To Optimize Therapy in Her2-Positive Breast Cancer): Compassher2 Residual Disease (Rd), A Double-Blinded, Phase III Randomized Trial Of T-Dm1 And Placebo Compared With T-Dm1 And Tucatinib This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing ...

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    Principal Investigator: Jose Galeas, MD

    Research Nurse: Wendy Blount, RN, MSN

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