Phase II Randomized Study of Fianlimab Plus Cemiplimab vs Cemiplimab Plus Placebo in First-Line Treatment of Participants with Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) that is Positive for PD-L1 Expression
Multiple Cancer Types
Esophageal,
Head/Neck
II
Choe, Jennifer
NCT06769698
VICCHN24568
Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy
Miscellaneous
Miscellaneous
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.
A rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.
The investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.
A rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.
The investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.
Miscellaneous
N/A
Sharpe, Jessica
NCT07555210
VICCMD25019
GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients with Solid Tumors that Harbor the p53 R175H Mutation
Miscellaneous
Miscellaneous
Miscellaneous
I
Berlin, Jordan
NCT06778863
VICCPHI24572
A Phase 2 Trial of Patients with Acute Myelogenous Leukemia and Myelodysplastic Syndrome Undergoing Reduced Intensity or Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation with Orca-T
Multiple Cancer Types
Leukemia,
Myelodysplastic Syndrome
II
Dholaria, Bhagirathbhai
NCT07216443
VICCCTT25025
Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
Not Available
II
Not Available
NCT05828069
VICC-NTPED24012
A Phase 3, Randomized, Double-Blind, Add-On Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Nave Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (POIESIS)
Hematologic
Hematologic
Hematologic
III
Mohan, Sanjay
NCT06479135
VICC-DTHEM24136
AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-Oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Multiple Cancer Types
Pediatric Lymphoma,
Pediatrics
III
Smith, Christine
NCT05675410
VICC-NTPED23306
A Phase 1/2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-Cell Therapies, in Subjects with Relapsed and/or Refractory B-Cell Lymphoma
Lymphoma
Lymphoma
Lymphoma
I/II
Jallouk, Andrew
NCT04989803
VICCCTTP25065
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Neuro-Oncology
Neuro-Oncology
Neuro-Oncology
Early I
Morone, Peter
VICCHN25072
Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing
Multiple Myeloma
Multiple Myeloma
This phase II trial tests daratumumab given at a reduced frequency with lenalidomide for maintenance therapy for the cost effective treatment of patients with multiple myeloma post stem cell transplant. Darzalex Faspor (also known as Daratumumab-hyaluronidase) is a combination of two drugs used alone or with other drugs to treat adults with certain types of multiple myeloma or light chain amyloidosis. Daratumumab binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase allows daratumumab to be given by injection under the skin. Daratumumab and hyaluronidase can be given in less time than daratumumab alone, which is given as an infusion. Lenalidomide may stop or slow cancer cells by blocking the growth of new blood vessels necessary for tumor growth. Daratumumab-hyaluronidase is typically given every 4 weeks per standard of care. Giving it every 8 weeks for the first year followed by every 16 weeks for years 2 through 4 in combination with lenalidomide may be equally as effective and reduce costs and treatment visits for patients with multiple myeloma post stem cell transplant.
Multiple Myeloma
II
Biltibo, Eden
NCT07485647
VICC-VCPCL23547
