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Nilotinib, Trametinib, and Dabrafenib for the Treatment of BRAF V600 Mutant Metastatic or Unresectable Melanoma

This phase I trial is to find out the best dose, possible benefits and/or side effects of nilotinib given together with trametinib and dabrafenib in treating patients with BRAF V600 mutant melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Nilotinib, trametinib, and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nilotinib together with trametinib and dabrafenib may lower the chance of cancer growing or spreading.
Not Available
I
Johnson, Douglas
NCT04903119
VICCMELP2274

ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter
pivotal studies to evaluate ALM-488.
Not Available
III
Rohde, Sarah
NCT05377554
VICCHN2258

Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

This is a Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin
18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally
Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic
Adenocarcinoma
Not Available
I
Gibson, Mike
NCT05539430
VICC-PHI22112

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to
standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with
intermediate-high or high risk for disease recurrence who completed definitive locoregional
therapy (with or without chemotherapy). The planned duration of treatment in either arm
within the study will be 7 years.
Not Available
III
Reid, Sonya
NCT05952557
VICC-DTBRE23083

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the
Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with
Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR
Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Not Available
III
Heumann, Thatcher
NCT05948475
VICC-DTGIT23271

Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer

This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.
Not Available
II
Not Available
NCT05770531
VICCBRE2257

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

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).
Not Available
II
Kishtagari, Ashwin
NCT05641831
VICC-ITHEM23019

Testing Chemotherapy versus Chemotherapy plus Radiotherapy Prior to Limited Surgery for Early Rectal Cancer

This phase III trial compares the effect of the combination of fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) or capecitabine and oxaliplatin (CAPOX) followed by limited surgery with transanal endoscopic surgery (TES) versus chemoradiation followed by TES for the treatment of early stage rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is in a class of medications called folic acid analogs. When used with fluorouracil, it enhances the effects of this chemotherapy drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cells DNA and may kill cancer cells. CAPOX is a combination of two drugs (capecitabine and oxaliplatin) and used as standard chemotherapy in treatment of rectal cancer. CAPOX works by damaging the DNA in tumor cells, and may cause the cells to stop growing and die. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. This study will help researchers find out if chemotherapy with FOLFOX or CAPOX prior to surgery works better, the same, or worse than the usual approach and improves the quality of life in patients with early rectal cancer.
Not Available
III
Eng, Cathy
NCT06205485
SWOGGICO32

Dinutuximab with Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children with Newly Diagnosed High Risk Neuroblastoma

This phase III trial tests how well adding dinutuximab to induction chemotherapy along with standard of care surgery radiation and stem cell transplantation works for treating children with newly diagnosed high risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found in greater than normal amounts on some types of cancer cells. This helps cells of the immune system kill the cancer cells. Chemotherapy drugs such as cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, dexrazoxane, doxorubicin, temozolomide, irinotecan and isotretinoin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. During induction, chemotherapy and surgery are used to kill and remove as much tumor as possible. During consolidation, very high doses of chemotherapy are given to kill any remaining cancer cells. This chemotherapy also destroys healthy bone marrow, where blood cells are made. A stem cell transplant is a procedure that helps the body make new healthy blood cells to replace the blood cells that may have been harmed by the cancer and/or chemotherapy. Radiation therapy is also given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of induction.
Not Available
III
Benedetti, Daniel
NCT06172296
VICC-NTPED24104

Hypofractionated Radiotherapy followed by Surgery for the Treatment of Soft Tissue Sarcomas

Sarcoma

This phase II trial studies the effect of hypofractionated radiotherapy followed by surgery in treating patients with soft tissue sarcoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiotherapy followed by surgery may allow patients with sarcomas to be treated in a much more rapid and convenient fashion.
Sarcoma
II
Shinohara, Eric
NCT04506008
VICCSAR2062