Joint Clinical Trials Office

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged AML

The purpose of this study is to evaluate the safety and effectiveness of Ziftomenib (KO-539) in patients with acute myeloid leukemia (AML). This study has 2 separate investigations (Nonintensive and Intensive). 

A Phase III, Multisite, Double-Blinded Randomized Trial of BNT327 In Combination with Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab In Combination with Chemotherapy In Participants with First-Line Extensive-Stage Small-Cell Lung Cancer

This clinical trial is for adults who have extensive stage small cell lung cancer (ES-SCLC) for which they have received no treatment.
   
The purpose of this study is to evaluate the effects of BNT327 (the “study drug”) when combined with chemotherapy (etoposide plus carboplatin), compared with standard of care, a drug called atezolizumab in combination with chemotherapy (etoposide plus carboplatin), to find out the following:
   

FMT and Other Gut Microbial Therapies National Registry: Acute Severe and Fulminant C. Difficile Infection

This registry study is being done to collect information on fecal microbiota transplantation (FMT) and other gut microbial therapies (GMTs). Participants in this research study will have been given an FMT, or other GMT. FMTs and other GMTs are standard medical care used to treat patients who have recurrent Clostridioides difficile infection.
   

GS-US-567-6968: Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta

This study is for men and women who have been diagnosed chronic hepatitis delta (Hep D). This study will test the experimental/investigational drug GS-4321.

Prospective randomized study of the Kono-S anastomosis versus the side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn’s disease

The purpose of this study is to compare the post-operative recurrence of Crohn’s disease (the return of the disease after surgery) and the surgical recurrence (additional surgery after the initial one) between the Kono- S procedure and the side-to-side functional end anastomosis.

A Phase 3 randomized open-label study of belantamab mafodotin in combination with lenalidomide and dexamethasone versus daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma who are ineligible for auto-SCT

The goal of this clinical trial is to compare the safety and efficacy of belantamab mafodotin combinated with lenalidomide and dexamethasone to the combination of daratumumab, lenalidomide and dexamethasone in participants who have newly diagnosed multiple myeloma and are not eligible for autologous stem cell transplantation. The study also wants to determihne if the study drug is safer and works better than the current standard of care treatment.

S2427: Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (BRIGHT)

 The purpose of this study is to test the good and bad effects of combining the study drug pembrolizumab with radiation therapy in people whose bladder cancer has shrunk or cannot be found after earlier treatment. The study doctors hope to learn if the study drug controls the cancer so patients don’t need to have their bladder removed.

Pembrolizumab is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). Pembrolizumab is approved by the FDA to treat other cancers. 

Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108

This registry study is being done with the Thoracic Surgery Oncology Group (TSOG), which is a collaboration between Memorial Sloan Kettering (MSK) and the American Association for Thoracic Surgery (AATS) to support thoracic surgery clinical trials. We hope to learn more about how different doctors perform the pulmonary segmentectomy surgery and how this type of surgery affects people with lung cancer.

Participants are being asked to join because they will undergo surgery and may or may not have lung cancer.

A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis

The study is researching an experimental drug called dupilumab (called “study drug” in this form) for children with active eosinophilic esophagitis (EoE). EoE is an inflammatory disease of the esophagus which impacts feeding and nourishment.

Experimental means that dupilumab is not approved by the U.S. Food and Drug Administration (FDA).

A Phase 1b/2, Multicenter, Randomized, Open-Label Study to Evaluate The Efficacy And Safety Of GSK5764227 Alone And In Combination In Participants With Previously Treated Advanced Unresectable Or Metastatic Gastrointestinal Solid Tumors

This clinical trial is for adults who have been diagnosed with advanced or metastatic colorectal cancer (CRC) OR advanced or metastatic pancreatic cancer (PDAC).