This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
This phase III trial compares how well endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) versus EBUS-TBNA plus transbronchial mediastinal cryobiopsy works to obtain adequate tissue samples for next generation sequencing (NGS). During usual care, if there is suspicion of cancer, a procedures known as an EBUS-TBNA is done to take sample of lymph nodes to evaluate for cancer spread. If there is suspected cancer in the lymph nodes, multiple samples are taken for molecular testing (NGS) to help guide treatment decisions. It requires a certain amount of tissue to send for the molecular testing which can be achieved with EBUS-TBNA about 70% of the time. Researchers want to find out if adding a biopsy tool currently used in usual care, known as a cryoprobe, can acquire more tissue for molecular analysis. The cryoprobe uses a freezing technique to biopsy and can potentially gather larger and higher quality tissue samples than the standard EBUS-TBNA method.
The goal of this trial is to see if active surveillance monitoring and hormonal therapy in
patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast
cancer, can be an effective management of the disease.
Participants will be asked to receive control hormonal therapy or an investigational hormonal
therapy treatment. Participants will be asked to return for evaluation with MRI at three
months and six months. Depending on the evaluation participants will have the option to
continue on the treatment. If the evaluation suggests surgery is recommended, the participant
will discontinue the study treatment and will undergo surgery. In addition to the treatment
and MRI evaluation, participants will be asked to provide blood sample to understand their
immune status, provide saliva sample for genetic testing, provide the study with a portion of
the tissue or slides generated from tissue removed during surgery performed as part of their
standard of care.
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of
BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with
advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in
participants with advanced solid tumors.
