Roseville, Michigan Clinical Trials

PRIMARY OBJECTIVES: I. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients treated with durvalumab (MEDI4736) plus tremelimumab. SECONDARY OBJECTIVES: I. To estimate the duration of response (DoR) among patients who achieve a complete response (CR) ...

PRIMARY OBJECTIVES: I. To assess 2-year overall survival in each treatment arm (fluorouracil, irinotecan hydrochloride, and oxaliplatin [modified (m)FOLFIRINOX] and gemcitabine [gemcitabine hydrochloride]/nab-paclitaxel [paclitaxel albumin-stabilized nanoparticle formulation]) in patients with resectable pancreatic cancer. II. If the stated threshold is met in one or both arms: to choose the better regimen ...

PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced ...

The study consists of a screening visit, a wash out period of up to 3 weeks, when existing phosphate lowering medication is withheld, an 8-week treatment period, in which all groups receive tenapanor, and a 4-week placebo-controlled, randomized withdrawal period, during which patients are re-randomized 1:1 to either remain on ...

PRIMARY OBJECTIVES: I. To evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib (BMN 673) in HRRD Medivation (MDVN)-positive patients. SECONDARY OBJECTIVES: I. To evaluate investigator assessed progression-free survival (IA-PFS) and overall survival (OS) associated with therapy in HRRD MDVN-positive patients. II. To evaluate ORR, ...

The COXEN program will not select a patient's therapy, but the type of chemotherapy that he/she will receive will be randomly decided. The patient's response to chemotherapy will be used to test the usefulness of the COXEN program, which is the main goal of this trial. Other potential tests to ...

Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab. Doses to be tested will be 7.5 mg, 15 ...

This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral vadadustat for the treatment of anemia in hemodialysis participants converting from epoetin alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance ...

PRIMARY OBJECTIVE: I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma. SECONDARY OBJECTIVES: I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard ...

PRIMARY OBJECTIVES: I. To determine feasibility and safety of long-term administration of two doses of a peripheral opioid receptor antagonist in patients with advanced non-small cell lung cancer (NSCLC) receiving first-line systemic therapy. SECONDARY OBJECTIVES: I. To explore whether patients randomized to one or both of the two study drug ...