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Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study

Leukemia

This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).
Leukemia
II
Kishtagari, Ashwin
NCT05641831
VICC-ITHEM23019

A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer

Multiple Cancer Types

This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
Gynecologic, Ovarian
III
Brown, Alaina
NCT07213804
VICCGYN26015

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

Rectal

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?
Rectal
III
Eng, Cathy
NCT06205485
SWOGGICO32

Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours

Germ Cell (Pediatrics)

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
Germ Cell (Pediatrics)
III
Borinstein, Scott
NCT02582697
COGAGCT1532

TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

Breast

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HER2-low or HER2-0) metastatic breast cancer.

The names of the study drugs involved in this study are:

* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)
Breast
II
Abramson, Vandana
NCT06533826
VICC-ITBRE23546

Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy

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.
Miscellaneous
N/A
Sharpe, Jessica
NCT07555210
VICCMD25019

Castrate Resistant Prostate Cancer Enhertu Therapy

Prostate

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
Prostate
II
Schaffer, Kerry
NCT06610825
VICCURO25040

Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors

Multiple Cancer Types

This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT--NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
Neuroendocrine, Phase I
I/II
Ramirez, Robert
NCT05636618
VICC-DTPHI23045

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Multiple Cancer Types

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
Pediatrics, Wilms / Other Kidney (Pediatrics)
II
Benedetti, Daniel
NCT04322318
COGAREN1921

Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing

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