This study is for patient that have been diagnosed with rhabdomyosarcoma (RMS). The investigational drug in this study is vinorelbine, vincristine, dactinomycin, and cyclophosphamide (together called VINO-AC with vincristine). The purpose of this study is to compare the effects, good and/or bad, vinorelbine has on people with high risk RMS. Also, to find out if adding maintenance therapy will help get rid of the cancer and/or lower the chance that the cancer comes back. Participants can expect to be in this study for 12 months and will include chemotherapy, radiation and possibly surgery.
This is a Phase 2 study measuring the effectiveness and safety of an antibody treatment called AK117 combined with a drug called azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS). AK117 is an "investigational" (not yet FDA approved) treatment, azacitidine is FDA approved. The primary purpose of the study is to find the best dose of AK117 for future trials. The study will enroll approximately 90 patients randomized in 3 groups (like flipping a coin), with each group receiving either AK117 in doses of 30mg/kg, 20mg/kg, or a placebo, in combination with azacitidine. The study includes a screening period, treatment period, and follow-up period over the course of 3 years. Patients will receive AK117 or a placebo every 2 weeks in combination with azacitidine every 4 weeks. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.
This study is to treat cutaneous squamous cell cancer that cannot be removed with surgery and is relatively large or has spread beyond its original location with the combination of radiation therapy and cemiplimab. Cemiplimab is FDA approved for this head and neck cancer, but the combination of cemiplimab and radiation is investigational. This treatment consist of 17 weeks of cemiplimab followed by 7 weeks of cemiplimab + radiation followed by 28 weeks of cemiplimab alone. There will be 3 clinic visits during treatment so the study doctor can check on the participant's health and see if they are having any side effects. Some of the most common risk and side effects that the study doctors know about are lack of energy or feeling tired (fatigue), loose or watery stools (diarrhea), rash, allergic reaction to study drug, and possible effects on liver, kidney, heart, and blood. Treatment will last a year with a follow-up call at the end of year 2.
The purpose of this study is to evaluate ABBV-400 in subjects with select solid tumors. This study will consist of
multiple cohorts with each cohort investigating ABBV-400 at 3 mg/kg Q3W.
The study will consist of a Screening, a Treatment, and a Follow-Up period.
All screening procedures must be performed within 28 days of first dose with the exception of tumor
tissue biopsy, which may occur during screening or any time after disease progression on the most
recent treatment. Subjects will continue treatment with ABBV-400 3 mg/kg Q3W until documented disease progression,
intolerable toxicity, or the subject meets other protocol criteria for discontinuation of treatment
(whichever occurs first). The maximum treatment duration will be 2 years.
This study is for participants who have acute leukemia, a type of cancer of the blood and bone marrow. This study will help us learn more about a newly discovered oral drug, DSP-5336, that is being tested in people with acute leukemia and other types of blood cancer. DSP-5336 is a drug that interferes with a protein (Menin) in the body that has been found to have a role in developing leukemia. The main purpose of this study is to evaluate how safe DSP-5336 is at different doses and to find a recommended dose that is safe for further study. The overall planned study duration, including the above visits and periods, is 50 months (4.2 years).
A clinical research study is an investigation in humans of a potential medical treatment that is designed to discover or verify whether it works and is safe. This study will test an investigational drug called DF9001. "Investigational" means that it has not been approved by any health authority such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Information gathered from this study will be sent to the various health authorities.
The study has two parts: a Dose Escalation part and an Efficacy Expansion part. The main purpose of the Efficacy Expansion part of this study is to test whether the study drug (DF9001) works (if it causes cancer to shrink or disappear). The Dose Escalation part of this study's main purpose is to test different doses of the study drug by itself, and also in combination with a drug called nivolumab, an FDA approved drug. Some foreseeable risks associated with DF9001 include Diarrhea,
Skin problems, Nail changes, Eye problems, Inflammation of the lungs, intestines and liver, as well as unforeseen side effects that may occur. There is no direct benefit in participating in this study.
This study is for patients who have been diagnosed with a solid tumor cancer that has continued to grow despite treatments patients have already received (non-small cell lung cancer or urothelial cancer). The study drug is FF-10832 (gemcitabine liposome injection). Gemcitabine is a cancer treatment registered in the US for the treatment of ovarian, breast, non-small cell lung, and pancreatic carcinomas. The study drug is a new, liposomal formulation of Gemcitabine. This new formula was developed to increase the amount of gemcitabine that goes to tumor cells. The study drug will be given to patients by itself, or in combination with pembrolizumab. Pembrolizumab is an approved treatment for many types of cancer. There are two groups that a participant may be assigned to, which group a participant is assigned on will be determined randomly, in a 1:1 ratio, like flipping a coin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will likely last 12 months, but participants may stay on the study longer if the study treatment continues to benefit them. The study consists of a screening visit, treatment visits, end of study visit, and a long-term follow-up.
This study investigates a new treatment, V940, combined with pembrolizumab for people who've had surgery for non-small cell lung cancer (NSCLC). The goal is to check if this combination is safe, prevents cancer from returning, improves survival, and enhances quality of life compared to a placebo plus pembrolizumab. Participants will receive pembrolizumab, a drug that boosts the immune system to fight cancer. V940, a personalized treatment, uses genetic information from a patient's tumor to create a custom mRNA injection. It's experimental and not FDA-approved, but it offers a novel approach to empower the immune system against cancer, potentially bringing advancements in post-surgery NSCLC care.
The study is for patients who have been diagnosed with an advanced/metastatic (meaning cancer has spread from where it started) solid tumor (cancer) with no standard treatment available. The investigational drug in this study is DB-1311. DB-1311 infusion is an antibody-drug combination composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (novel topoisomerase I inhibitor). The antibody portion of the drug blocks a protein in the body that help cancer cells live, grow and spread. The purpose of this trial is to find a safe and tolerable dose of the study drug. Participation in this study will last about 24 months. The study consists of a screening visit, treatment visits, and a safety follow up visit.
This study is for patients with invasive breast cancer among premenopausal, early-stage breast cancer with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 and 0-25. The study is being done to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal patients. The drug being used in this study are aromatase inhibitors. Patients will expect to remain in the study for up to 5years.