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Adult Interventional Trials May 2021

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Adult Interventional Trials May 2021 Adult Cancers Breast (24 trials) Cutaneous (13 trials) Gastrointestinal (15 trials) Genitourinary (29 trials) Gynecological (5 trials) Head and Neck (7 trials) Malignant Hematology (31 trials) Multiple / Ill-Defined Disease Sites (14 trials) Neurologic Oncology (8 trials) Thoracic (12 trials) Other Trials (92 trials) Total Trials = 250 Adult Interventional Trials May 2021 UCSF Protocol ClinicalTrials.gov PI Name Title Protocol Type Study Contact No. Protocol Breast > Prevention 16752 NCT02620852 Esserman, Laura The WISDOM Study (Women Informed to Screen Depending on Measures of Risk) Screening [email protected] Breast > Breast Cancer Treatment > Advanced Breast Cancer 187523 NCT03344965 Melisko, Michelle A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients with Germline Treatment [email protected] or Somatic Mutations in DNA Repair Genes "Olaparib Expanded" EA-RUGO- NCT04395508 Rugo, Hope EXPANDED ACCESS, SINGLE-ARM, MULTICENTER STUDY TO PROVIDE AT HOME Other [email protected] 5142020 SUBCUTANEOUS ADMINISTRATION OF PERTUZUMAB AND TRASTUZUMAB FIXED-DOSE COMBINATION (PH FDC SC) FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER DURING THE COVID-19 PANDEMIC Breast > Breast Cancer Treatment > Early Stage Breast Cancer 167514 NCT03094052 Chien, Jo An open label study to characterize the incidence and severity of diarrhea in patients with Treatment [email protected] HER2+ breast cancer treated with neratinib with or without trastuzumab 16704 NCT02872025 Esserman, Laura Testing the Ability of Pembrolizumab and mRNA 2752 to Alter the Tumor Immune Treatment [email protected]; MicroEnvironment (TIME) of High Risk DCIS [email protected] 19753 NCT03562637 Melisko, Michelle The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Treatment [email protected] Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple Negative Breast Cancer Breast > Breast Cancer Treatment > Radiation 117515 NCT01570998 Alvarado, Michael Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Treatment [email protected]; Registry Trial of Targeted Intraoperative Radiation Therapy following Breast-Conserving [email protected] Surgery last updated 5/3/2021 Page 2 Adult Interventional Trials May 2021 UCSF Protocol ClinicalTrials.gov PI Name Title Protocol Type Study Contact No. Protocol Breast > Breast Cancer Treatment > Advanced Breast Cancer > ER+ 19754 NCT03858972 Rugo, Hope Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Treatment [email protected] Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane 20757 NCT04305496 Rugo, Hope A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib Treatment [email protected] + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment with an Aromatase Inhibitor (CAPItello-291) 197511 NCT03781063 Rugo, Hope An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative Treatment [email protected] to Fulvestrant for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation 187526 NCT03250676 Munster, Pamela A Phase I-II multicenter, open label trial of H3B-6545, a covalent antagonist of estrogen receptor Treatment [email protected] alpha, in women with locally advanced or metastatic estrogen receptor-positive, HER2 negative breast cancer 18751 NCT03326102 Melisko, Michelle A Multi-center, Open-Label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Treatment [email protected] Pharmacokinetics of DHP107 (Liporaxel, Oral Paclitaxel) Compared to IV Paclitaxel in Patients with Recurrent or Metastatic Breast Cancer 197520 NCT04190056 Munster, Pamela Epigenetic priming for Immune therapy in ER-positive breast cancer in biomarker select Treatment [email protected] population 157521 NCT03095352 Rugo, Hope A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Treatment [email protected] Antibody, in Combination with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease Breast > Breast Cancer Treatment > Advanced Breast Cancer > HER2+ 157521 NCT03095352 Rugo, Hope A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Treatment [email protected] Antibody, in Combination with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease 197516 NCT04042701 Rugo, Hope A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), Treatment [email protected] An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC) 20754 NCT03975647 Chien, Jo Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado- Treatment [email protected] trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer(HER2CLIMB-02) Breast > Breast Cancer Treatment > Early Stage Breast Cancer > Invasive 187513 NCT03422003 Park, Catherine Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) Supportive Care 1-877-827-3222 for Invasive Breast Carcinoma last updated 5/3/2021 Page 3 Adult Interventional Trials May 2021 UCSF Protocol ClinicalTrials.gov PI Name Title Protocol Type Study Contact No. Protocol Breast > Breast Cancer Treatment > Advanced Breast Cancer > Triple Negative 207516 NCT04461600 Rugo, Hope TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Treatment [email protected] Patients with Notch-activated Triple Negative Breast Cancer 199516 NCT03829436 Munster, Pamela A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Treatment 1-877-827-3222 Single Agent or in Combination with Systemic Anti-Cancer Therapies in Subjects with Advanced Solid Tumors 197525 NCT04191135 Rugo, Hope An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Treatment [email protected] Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009) 157521 NCT03095352 Rugo, Hope A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Treatment [email protected] Antibody, in Combination with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease Breast > Breast Cancer Treatment > Advanced Breast Cancer > Brain Metastases/leptomeningeal dz 197515 NCT03501979 Melisko, Michelle A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Treatment [email protected] Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer 17752 NCT02915744 Melisko, Michelle A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Treatment [email protected] Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine Breast > Breast Cancer Treatment > Early Stage Breast Cancer > Invasive > Neoadjuvant 097517 NCT01042379 Chien, Jo I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Treatment [email protected]; Imaging and Molecular Analysis 2) [email protected]; [email protected] 177539 NCT02206984 Mukhtar, Rita A Trial of Endocrine Response in Women with Invasive Lobular Breast Cancer Treatment [email protected] last updated 5/3/2021 Page 4 Adult Interventional Trials May 2021 UCSF Protocol ClinicalTrials.gov PI Name Title Protocol Type Study Contact No. Protocol Cutaneous > Melanoma 18859 NCT03820986 Daud, Adil A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Treatment [email protected] Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003) 20863 NCT04598009 Tsai, Katy A phase II study of binimetinib in combination with imatinib in patients with advanced KIT-mutant Treatment [email protected] melanoma 19854 NCT03684785 Daud, Adil A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab in Patients Treatment [email protected] with Advanced Solid Tumors 19855 NCT04135352 Daud, Adil A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of V938 in Treatment [email protected] Combination with Pembrolizumab (MK-3475) in Participants with Advanced/Metastatic or Recurrent Malignancies 18851 NCT03132675 Tsai, Katy A Multicenter Phase 2, Open Label Study of Intratumoral Tavo Plus Electroporation in Treatment [email protected]; Combination With Intravenous Pembrolizumab in
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