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A Phase 2 Open-label Multicenter Cohort Study of ALKS 4230 Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6
The purpose of the study is to evaluate the antitumor activity, safety and tolerability of ALKS 4230 given as monotherapy in patients with unresectable and ... -
A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil Leucovorin and Liposomal Irinotecan in Older Patients with Treatment Na ve Metastatic Pancreatic Cancer (GIANT) ( s21-00700)
The purpose of the study is to determine which of two treatment combinations, Gemcitabine and Nab-paclitaxel or 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan, is more effective ... -
A Phase 2 Multicenter Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-line Treatment (CodeBreaK 201)
The purpose of the study is to determine the anti-tumor effect (safety and tolerability) of sotorasib monotherapy in subjects with metastatic non-small cell lung cancer ... -
A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
In stage 1 (early) HER2+ breast cancer, lesser chemotherapy is needed to achieve excellent long-term survival. The current standard therapy is TH (paclitaxel plus trastuzumab ... -
A Randomized Double-blind Placebo-controlled Parallel-group Multicenter Study to Assess the Effect on Cognitive Decline and Safety of JNJ 63733657 an Anti tau Monoclonal Antibody in Participants with Prodromal Alzheimer s Disease
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called JNJ-63733657 for treating subjects with Early Alzheimer’s ... -
A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop) [EA6192]
The purpose of the study is to evaluate and determine how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients ... -
A Phase 2 Randomized Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Nab-Paclitaxel or Paclitaxel versus Nab-Paclitaxel or Paclitaxel in Previously Untreated Patients with Metastatic Triple-Negative Breast Cancer
Magrolimab is a novel immune checkpoint inhibitor (targeting macrophages in the tumor to support killing of tumor). The purpose of the study is to determine ... -
Single-arm open label phase II study of MBG453 (sabatolimab) added to FDA approved Hypomethylating agents of investigator s choice (IV/SC/Oral) for patients with intermediate high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria (US multi-center) (STIMULUS MDS-US)
The purpose of the study is to describe and evaluate safety and efficacy of MBG453 (sabatolimab) in combination with FDA approved Hypomethylating agents (HMA). We ... -
A novel Phase 2 double-blind randomized controlled clinical trial to evaluate the efficacy of centrally acting non-toxic ACE inhibition in cognitive impairment associated with SLE
This research study is being done to test the effects of centrally-acting ACE inhibitor, named lisinopril, on resting metabolism in the brain and on cognitive ... -
A Phase 2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis
The purpose of this study is to see if an experimental drug called MK-3655 helps people with a liver disease called nonalcoholic steatohepatitis (NASH). “Experimental ...