Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
Head/Neck
Head/Neck
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.
Head/Neck
II
Choe, Jennifer
NCT07195734
NRGHNHN015
Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer
Multiple Cancer Types
This phase I/II trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs like carboplatin, pemetrexed, and paclitaxel 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. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.
Lung,
Non Small Cell,
Phase I
I/II
Osmundson, Evan
NCT05501665
VICCTHOP2185
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate
Prostate
The purpose of this study is to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246, a cluster of differentiation 46 (CD46) targeting antibody-drug conjugate (ADC), in the treatment of participants with mCRPC who have progressed following treatment with one prior second-generation androgen receptor signaling inhibitor (ARSI) in any setting and no prior taxane therapy in the mCRPC setting.
Prostate
II
Schaffer, Kerry
NCT06842498
VICCURO24538
Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPACT Study
Leukemia
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
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Head/Neck
Head/Neck
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
Head/Neck
N/A
Murphy, Barbara
NCT06125743
VICC-EDHAN23569
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:
* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:
* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
Not Available
III
Not Available
NCT05253651
VICC-DTGIT23052
Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma
Liver
Liver
RBS2418 is a targeted immune modulator that inhibits ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1). It is designed to promote anti-tumor immunity by preserving endogenous 2'-3' cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis, thereby activating antigen-presenting cells and promoting robust T cell activation. Ideally, RBS2418 acts synergistically with CTLA-4 inhibitors, such as those in the STRIDE regimen (Tremelimumab plus Durvalumab). The hypothesis is that RBS2418 combined with STRIDE will be safe, well-tolerated, highly immunogenic, and enhance anti-tumor responses in adult participants with advanced, unresectable hepatocellular carcinoma (HCC) compared to STRIDE alone.
Liver
II
Heumann, Thatcher
NCT07175441
VICCGI25054
Safely Optimizing Body Weight With Mifomelatide (TCMCB07) in Patients With Newly Diagnosed Colorectal Cancer (CRC) or Pancreatic Ductal Adenocarcinoma (PDAC) Undergoing Chemotherapy
Colon
Colon
This is a randomized, double-blind, placebo-controlled basket trial evaluating mifomelatide (TCMCB07) administered daily by subcutaneous (SC) injection in up to 120 patients. Patients will be enrolled into two cohorts 1) patients with newly diagnosed, advanced, unresectable colorectal cancer (CRC) or 2) patients with newly diagnosed, advanced, unresectable pancreatic ductal adenocarcinoma (PDAC). Within each cohort, patients will be randomized 1:1:1:1 to receive placebo or one of three different doses of mifomelatide (12.5 mg, 25 mg, or 50 mg). This study is designed to evaluate the effects of different doses of mifomelatide on weight, body composition and BMI. The double-blind (DB) phase will generally begin on the first day of the second cycle of first-line cancer chemotherapy and continue for 12-weeks with the goal of maintaining body weight and muscle mass in patients undergoing chemotherapy relative to control. Upon completion of the DB treatment period, eligible patients may enroll in an optional Open Label Extension (OLE) phase and receive mifomelatide SC 25 mg daily for up to an additional 26 weeks. The purpose of the OLE is to further evaluate long-term safety, tolerability and efficacy of mifomelatide.
Colon
II
Agarwal, Rajiv
NCT06937177
VICCSUPP26003
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Multiple Cancer Types
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.
Leukemia,
Myelodysplastic Syndrome
I
Ball, Somedeb
NCT06994676
VICCHEMP25017
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
Miscellaneous
Miscellaneous
The goal of this study is to test autologous logic-gated Tmod CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment and Apheresis in BASECAMP-1 (NCT04981119)
Preconditioning Lymphodepletion (PCLD) Regimen
Tmod CAR T cells at the assigned dose
The main questions this study aims to answer are:
Phase 1: What is the recommended dose that is safe for patients
Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
Enrollment and Apheresis in BASECAMP-1 (NCT04981119)
Preconditioning Lymphodepletion (PCLD) Regimen
Tmod CAR T cells at the assigned dose
Miscellaneous
I/II
Eng, Cathy
NCT06051695
VICCPHI24512
