This study is for adult patients with Oral Squamous Cell Carcinoma (OSCC). The purpose of this study is to use results from a CLIA regulated blood test (NavDx) to measure tumor DNA to omit postoperative radiotherapy following surgery. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 2 years with a 3 year follow up period.
This study is for patients that have been diagnosed with locally advanced or metastatic solid tumor, including non-small cell lung cancer (NSCLC), triple-negative breast cancer, gastric cancer, esophageal cancer (or gastroesophageal cancer), head and neck squamous cell cancer, ovarian cancer, endometrial cancer, or cervical cancer. The study is testing and investigational drug called NRM-823. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety and tolerability of NRM-823 as monotherapy and in combination with pembrolizumab. The study drug is given as an injection into the stomach (or another place, like the thigh). An injection is like a shot between the skin and muscle so that the drug can enter your body. Participants can expect to be on this study until the first radiographic disease progression.
This study is for patients that have been diagnosed with diagnosed with primary advanced or recurrent endometrial cancers that express high levels of the human epidermal growth factor receptor 2 (HER2) protein and that have a genetic characteristic known as mismatch repair proficiency (pMMR). The study is testing investigational drugs called Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The purposed of this study is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy. The study drugs are given by infusion. Participants in this study can expect to be in this study for as long as you are receiving benefit from the treatment.
This study is for patients that have been newly diagnosed with GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL). This study is testing an investigational drug called zilovertamab vedotin. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In the study, participants will be randomized to two different groups (like flipping a coin). The first group will receive zilovertamab vedotin plus R-CHP [rituximab, cyclophosphamide, doxorubicin, and prednisone]. The second group will receive the standard care regimen: polatuzumab vedotin plus R-CHP. The drugs will be given through an IV, and prednisone may be given to participants by mouth. The primary purpose of the study is to learn if zilovertamab vedotin plus R-CHP is safe and effective for treating DLBCL. Participants in this study can expect to be in this study for up to 5.5 years. The first six months will be participation in treatment, and the following five years will be follow-up.
This phase III trial compares the effectiveness of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Participants will be separated into two groups, or randomized (like flipping a coin). The first group of participants will receive high dose chemotherapy followed by an autologous stem cell transplant. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. The second group will be observed by the study doctor and study team with check-ins every six months for 12 years after joining the trial. The group of participants who receive a stem cell transplant will also be checked by their doctor and study team for every 6 months for 12 years after joining the study. The main risks of the study treatment include reduced blood cell counts, nausea and vomiting, and damage to other organs (due to high dose chemotherapy).
This study is for participants that have been diagnosed with Intermediate or High-risk Primary or Secondary Myelofibrosis. This study is testing an investigational drug called Nuvisertib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the efficacy and safety of Nuvisertib. Nuvisertib is an oral PIM1 selective inhibitor. A PIM1 selective inhibitor is a drug that specifically targets and blocks the activity of the PIM-1 kinase, an enzyme implicated in cancer cell growth. This drug is given to participants by mouth. Participants in this study can expect to be in the treatment phase of this study for 19 months and the long term follow up phase for 3 years.
This study is for patients that have been diagnosed with metastatic or locally advanced unresectable solid tumors with tumor protein 53 (TP53) mutation/loss with or without brain metastasis. This study is testing an investigational drug called AO-252. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the maximum tolerated dose (MTD), the recommended phase II does (RP2D), and the safety profile of AO-252. The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months, followed by a 12-month follow-up period.
The purpose of this study is to test the safety of NXC-201 at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis.
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells (a type of white blood cell that is part of the immune system) in the bone marrow. Misfolded proteins produced by these cells can build up in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage.
NXC-201 is made using a person's own T Cells (immune system cells that protect the body from infections, cancer, and other possible harms). The T cells are collected then genetically modified (changes are made to the DNA or genes) outside of the body in a laboratory. A virus is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells. The virus then becomes inactive. The changes are designed to help the NXC-201 cells find and destroy plasma cells that have a protein on their surface called B-cell maturation antigen (BCMA). T-cell therapies like NXC-201 are called CAR T-cell therapies. After being reinjected, the CAR-T cells multiply and spread throughout the body.
NXC-201 is an investigational "treatment", which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of AL Amyloidosis or any other disease.
Calling the study drug a "treatment" in this consent form does not indicate that it will be effective in treating your AL Amyloidosis.
Before receiving NXC-201, participants will receive lymphodepleting chemotherapy (or lymphodepletion) with cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. The lymphodepletion will help prepare the body for receiving NXC-201. Cyclophosphamide and fludarabine are FDA-approved for use as lymphodepleting chemotherapy.
This study is sponsored by Nexcella, Inc., which is responsible for funding and organizing the study.
This study is for patients who have been diagnosed with bladder cancer and are eligible to receive chemotherapy and radiation therapy while keeping their bladder. The study is testing an investigational radiation schedule called stereotactic body radiation therapy (SBRT), which delivers higher doses of radiation over fewer treatment sessions. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA).
Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive the usual chemotherapy and standard radiation therapy schedule, which involves lower radiation doses given five days a week for 4 to 5 weeks. The other group will receive the usual chemotherapy and the study radiation schedule (SBRT), which delivers higher doses of radiation in fewer treatments over a shorter period of time.
The primary purpose of this study is to find out whether the shorter radiation schedule is as effective as the usual radiation schedule at preventing bladder cancer from getting worse and avoiding bladder removal surgery.
Radiation therapy and chemotherapy will be given while the bladder remains in place. After treatment is complete, participants will be followed by the study doctor for up to 5 years to monitor for side effects and whether the cancer returns or progresses.
All participants can expect to complete questionnaires about symptoms and quality of life at several time points during and after treatment. These questionnaires are part of the research and will not be shared with treating physicians. There will be a total of 16 patients enrolled locally over 48 months.
This study is testing a new medicine called Visugromab (CTL-002) to see if it helps people with a type of lung cancer called metastatic non-squamous non-small cell lung cancer. Everyone in the study will get standard cancer treatment, but some will also get Visugromab while others get a placebo (a look-alike with no active drug), and who gets what is decided randomly—like flipping a coin. The goal is to find out if Visugromab makes the treatment more effective and safe. The study will last up to two years, with Treatment in cycles lasting 3 weeks, about once a month. Researchers will closely monitor participants to see how well the treatment works and how their bodies respond. Serious risks of treatment may include heart problems, low oxygen levels, infections, organ failure, and inflammation in various parts of the body such as the lungs, liver, intestines, pancreas, and thyroid.