H. Lee Moffitt Cancer Center And Research Institute

This study tests a new treatment schedule for people with metastatic Ewing sarcoma, a rare and aggressive cancer. The approach uses an intense first attack on cancer cells, followed by targeted strikes and long-term maintenance to wipe out remaining cells. The goal is a cure. The…

This early-phase trial tests a personalized vaccine made from a patient's own immune cells (dendritic cells) trained to recognize unique proteins from their leftover breast tumor after standard chemotherapy and surgery. The goal is to see if the vaccine is safe and can boost the …

This study tests a program that sends personalized text messages and provides nicotine patches to help people with HIV in Cambodia stop smoking. Researchers will enroll 800 smokers and check if they quit after 6 months using self-reports and breath tests. The goal is to find a pr…

This study tests a personalized treatment for advanced melanoma using a patient's own immune cells, called tumor-infiltrating lymphocytes (TIL), which are boosted with a protein called CD40L. After a short course of chemotherapy to make room, the enhanced cells are infused back a…

This early-stage trial is testing whether the drug cemiplimab (Libtayo) is safe and effective when given before surgery to remove Merkel cell carcinoma or cutaneous squamous cell carcinoma. About 36 people with stage I–II cancer will receive the drug every three weeks for up to n…

This study is creating a mobile health (mHealth) system to help cancer patients stop smoking. Researchers will test if a smartphone app, combined with nicotine replacement therapy, is easy to use and acceptable to patients. The goal is to build a resource that can be used across …

This study tests a new two-step approach for men with advanced prostate cancer that has stopped responding to standard hormone therapy. First, patients receive a high dose of testosterone, followed by a targeted radioactive drug. The goal is to see if this combination is safe and…

This study compares two drugs, ruxolitinib and prednisone, as the first treatment for chronic graft-versus-host disease (cGVHD), a complication after bone marrow transplant. About 120 adults who need systemic therapy for cGVHD will be randomly assigned to receive one of the two d…

This phase 2 trial is testing the immunotherapy drug pembrolizumab, given alone or with chemotherapy, in 318 Black patients with advanced non-small cell lung cancer. The goal is to see how well these treatments work in real-world settings and to find biological markers that predi…

This phase 2 study tests whether the drugs tafasitamab and lenalidomide can shrink or eliminate large B-cell lymphoma that remains after treatment with CAR-T therapy (axicabtagene ciloleucel). About 28 adults with this type of lymphoma will receive the drug combination for up to …

This study compares four different dosing schedules of the drug vismodegib in people with advanced basal cell carcinoma. The goal is to see if personalized, intermittent dosing works as well as or better than standard continuous dosing while being easier to tolerate. About 34 adu…

This phase 2 trial tests the immunotherapy drug pembrolizumab (Keytruda) in 17 adults with advanced cutaneous sarcomas (excluding angiosarcoma). Participants receive an IV infusion every 3 weeks. The main goal is to see if tumors shrink, with additional tracking of survival and p…

This early-phase trial tests an investigational drug called ropeginterferon in 38 adults with cutaneous T-cell lymphoma (CTCL), a rare type of skin cancer. Participants must have tried at least two prior treatments without success. The main goals are to find the safest dose and s…

This study tests a two-step treatment for people with a rare eye cancer (uveal melanoma) that has spread only to the liver. First, a chemotherapy drug is delivered directly to the liver through a special procedure. Then, an immunotherapy drug is given to help the immune system at…

This early-phase study is testing whether taking a daily 325 mg aspirin alongside standard chemotherapy can reduce immune-suppressing cells in ovarian, fallopian tube, or peritoneal tumors. About 100 women will take either aspirin or a placebo for up to 5 cycles of chemo. The goa…

This phase 2 trial is testing whether using MRI scans to adjust radiation therapy can better protect healthy organs in people with head and neck cancer. The study will enroll 35 patients who will receive standard intensity-modulated radiotherapy, but with a personalized boost gui…

This phase 2 trial tests KTE-X19 (Tecartus), a personalized CAR T-cell therapy, in adults with B-cell acute lymphoblastic leukemia who are in remission but still have tiny amounts of cancer cells (minimal residual disease). The goal is to see if this treatment can clear those lef…

This early-stage trial is testing a new approach for people with advanced non-small cell lung cancer that has specific gene changes (EGFR, ALK, ROS1, or HER2). Doctors take immune cells from the patient's own tumor, boost them in the lab with a molecule called CD40L, and then giv…

This study tests whether giving focused radiation to large tumors before CAR-T cell therapy can help control aggressive large B-cell lymphoma that has come back or not responded to treatment. About 27 adults with tumors at least 5 cm will receive this combination. The goal is to …

This phase 2 trial tests whether giving the drug itacitinib before CAR-T cell therapy can improve outcomes for people with diffuse large B-cell lymphoma (DLBCL). The study will enroll 27 adults who are eligible for CAR-T treatment. Participants take itacitinib daily from after ce…

This phase 2 trial tests whether combining high-dose interleukin-2 with low-dose ipilimumab, followed by nivolumab, can shrink tumors in people with advanced melanoma that has stopped responding to prior immunotherapy. About 29 participants with inoperable stage III or IV melanom…

This study tests whether the drug afatinib can shrink tumors in people with advanced cutaneous squamous cell carcinoma (a type of skin cancer) that cannot be treated with surgery or radiation. About 25 adults with adequate organ function will receive afatinib, and researchers wil…

This phase 2 trial is testing enfortumab vedotin, a drug that delivers chemotherapy directly to cancer cells, in 40 adults with advanced colorectal or liver cancer that has worsened after standard treatments. The main goal is to see if the drug can shrink tumors. Researchers will…

This early-stage trial tests a new approach for men with metastatic castration-resistant prostate cancer that has spread to the bone and no longer responds to standard treatments. Researchers take a patient's own immune cells (gamma delta T cells), genetically modify them to reco…

This study tests whether adding the targeted drug venetoclax to a standard chemotherapy regimen (CLAG-M) can improve outcomes for adults with relapsed or refractory acute myeloid leukemia (AML). About 52 participants will be randomly assigned to receive either CLAG-M alone or CLA…

This phase 2 trial tests whether adding the drug pirtobrutinib to a CAR-T cell therapy (brexucabtagene autoleucel) works better than CAR-T alone for people with mantle cell lymphoma that has come back or stopped responding to treatment. About 60 adults will be randomly assigned t…

This phase 2 trial tests the immunotherapy drug nivolumab (Opdivo) given before and after surgery for people with stage III or IV melanoma. The goal is to see if tailoring treatment based on tumor biomarkers leads to better outcomes. About 90 participants will be enrolled at a si…

This early-phase study tests a combination of two drugs, avapritinib and decitabine, for people with a rare blood cancer called systemic mastocytosis with an associated hematologic neoplasm (SM-AHN). The goal is to find a safe dose that can control both parts of the disease. Abou…

This early-phase study tests the safety and best dose of asciminib, a daily pill, in adults with a certain type of leukemia (Ph+ ALL) who have already received a stem cell transplant or CAR T therapy. The goal is to see if taking asciminib afterward can help prevent the cancer fr…

This early-phase study is testing whether adding a drug called calaspargase pegol to standard chemotherapy (Hyper-CVAD) is safe and tolerable for young adults newly diagnosed with acute lymphoblastic leukemia (ALL). About 7 participants will receive the combination after completi…

This study tests whether adding a personalized dendritic cell vaccine to standard chemotherapy and targeted therapy can help people with HER2-positive breast cancer. About 53 participants will receive the vaccine alongside standard drugs before surgery. The main goal is to see if…

This early-phase trial tests whether giving different drug combinations after surgery, based on how well the tumor responded to initial treatment, can reduce the risk of melanoma returning. About 50 adults with stage III or IV BRAF-mutant melanoma will receive encorafenib, binime…

This study tests whether digoxin, a heart medication, can help children and young adults with a specific type of relapsed brain cancer called non-WNT/non-SHH medulloblastoma. About 23 participants aged 1 to 29 will receive digoxin to see if it stops the cancer from growing for at…

This study looks at whether people with acute myeloid leukemia (AML) who have been on a combination of azacitidine or decitabine plus venetoclax for a year can stop treatment if tests show no remaining cancer cells. Researchers want to see if these patients can stay in remission …

This early-phase trial is testing the safety of combining two drugs—Vyxeos and gemtuzumab ozogamicin—for adults newly diagnosed with acute myeloid leukemia. Researchers want to find the best dose that doesn't cause severe side effects. The study will also look at how many patient…

This study tests whether using a patient's genetic profile to customize radiation doses can better control triple negative breast cancer after lumpectomy. About 86 participants will receive genomically guided radiation therapy. The goal is to prevent cancer from returning in the …

This early-phase study tests an experimental vaccine made from a patient's own immune cells, designed to target two cancer-related proteins (HER2 and HER3). The vaccine is injected directly into the tumor alongside standard chemotherapy before surgery. The goal is to find the saf…

This study is testing whether combining a targeted drug (abemaciclib) with precise radiation (stereotactic radiosurgery) can better control brain tumors in people with a common type of breast cancer (HR+/HER2-). About 31 participants will receive both treatments along with hormon…

This phase 2 study is testing a combination of two drugs—rituximab and zanubrutinib—in people with untreated follicular lymphoma or marginal zone lymphoma, both slow-growing B-cell cancers. The goal is to see how well the combo shrinks tumors and how safe it is. About 43 particip…

This study tests whether adding two drugs (sacituzumab govitecan and zimberelimab) to precise brain radiation can help people with metastatic triple negative breast cancer that has spread to the brain. The trial will enroll 31 adults and compare the combination against sacituzuma…

This early-stage study tests a new treatment for people with ovarian cancer that has come back. The therapy uses a patient's own immune cells, which are modified in a lab to recognize and attack a protein (FSHR) found on cancer cells. The main goal is to check the safety of these…

This early-stage study tests a combination of two drugs, vyxeos and gilteritinib, for adults whose FLT3-mutated acute myeloid leukemia has come back or not responded to prior treatment. The goal is to find the safest dose and see how many patients achieve remission. Participants …

This study tests whether special MRI scans can help doctors deliver higher doses of radiation to the most aggressive parts of a high-grade soft tissue sarcoma. About 43 adults with this rare cancer will receive radiation guided by these scans before surgery. The goal is to see if…

This study tests whether combining two drugs, dostarlimab and niraparib, can shrink tumors or slow the growth of advanced penile cancer in patients whose cancer has worsened after chemotherapy. About 25 adults with stage III or IV penile cancer will receive the combination treatm…

This study tests whether two drugs, cemiplimab and ziv-aflibercept, can shrink or stop the growth of metastatic uveal melanoma, a rare eye cancer that has spread. About 32 adults with this condition will receive the combination treatment. The goal is to see if the drugs work bett…

This phase 2 study tests whether combining two drugs—axitinib (a targeted therapy) and ipilimumab (an immunotherapy)—can shrink tumors in people with advanced melanoma that has stopped responding to standard treatment. The trial plans to enroll 25 participants. Researchers will m…

This early study tests whether combining a special immune-boosting vaccine (DC1) with the drug elacestrant is safe and doable for people with a common type of advanced breast cancer (HR+ HER2-). About 18 participants will receive the treatment for 8 weeks. The goal is to see if t…

This phase 2 trial tests whether the drug elranatamab, given as maintenance therapy after CAR-T cell treatment (cilta-cel), can delay cancer progression in people with high-risk relapsed myeloma. The study enrolls 39 patients whose myeloma has features like high-risk mutations or…

This pilot study tests a new way of giving several already-approved chemotherapy drugs in a specific order to treat hormone-positive metastatic breast cancer. The idea is to hit the cancer with a 'first strike' and then a 'second strike' to make treatment more effective. The stud…

This study tests whether a combination of two drugs, ACR-368 and low-dose gemcitabine, can shrink tumors or slow cancer growth in people with head and neck cancer that has come back or spread. About 43 adults will receive the drugs every two weeks. The goal is to see if the treat…

This study is testing whether routine brain MRIs can find brain metastases in stage IV breast cancer patients who have no neurological symptoms. Researchers will scan 170 participants at the start and again at 6 months or when their cancer first progresses. The goal is to see how…

This phase III trial is testing whether routine brain MRIs every 6 months can detect brain metastases earlier in people with stage IV breast cancer who have no symptoms. Participants are randomly assigned to either scheduled scans or standard care (scans only if symptoms appear).…

This study is testing whether certain biomarkers in blood and lung tissue can help doctors tell if a lung nodule is cancer, predict the risk of cancer coming back after surgery, and monitor for late recurrence. Researchers will follow 250 people with suspicious lung nodules or re…

This study is testing whether a simple mouth rinse can detect HPV-related throat cancer early, before symptoms appear. Researchers will compare results from 200 people with throat cancer and 200 healthy volunteers matched by age, sex, and background. If accurate, this test could …

This study looks at whether giving people personalized information about their skin cancer risk can encourage them to protect their skin. About 2,900 adults from community health centers will provide a saliva sample for genetic testing and answer questions about their sun habits.…

This study tests a 9-week mindfulness program (MBRP-SA) designed to help cancer survivors quit smoking and reduce heavy drinking. Six hundred participants in Florida will either get the mindfulness program plus nicotine patches or standard quitline support. The goal is to see if …

This study tests whether a remote exercise and nutrition program is practical and acceptable for people with pancreatic cancer who are waiting for surgery. Participants will use a Fitbit, get nutrition advice, and do resistance training at home. The goal is to see if this 'prehab…

This study tests a 12-week program that combines a Fitbit activity tracker with personalized nutrition counseling from a dietitian for people recovering from pancreatic cancer surgery. Participants log their food intake and share data remotely, while completing surveys about thei…

This study tests a program called STRONG that provides remote dietitian visits and food tracking for people with gastroesophageal cancer. The goal is to see if this approach is practical and helps reduce malnutrition compared to usual care. About 80 participants will receive nutr…

This study tests whether a smartphone app that uses augmented reality (AR) can help people quit smoking when used alongside standard quitline counseling. The app shows smoking-related cues to help users manage cravings. The trial will enroll 3,600 adult daily smokers and measure …

This study tests whether the MIND diet, a mix of the Mediterranean and DASH diets, can improve thinking, memory, and energy in breast cancer survivors who have ongoing brain fog. Two hundred survivors who finished treatment 6 months to 3 years ago will either follow the MIND diet…

This study looks at whether a short exercise program before surgery is practical and helpful for people with esophageal cancer. About 20 patients will take part. The goal is to see if patients can stick with the program and if it improves their recovery.

This study looks at how obesity might help cause pancreatic cancer, especially in African American and non-Hispanic White people. Researchers will compare tumors and fat tissue from 125 adults to find differences that could lead to better treatments. The goal is to understand why…

This study follows 100 adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) for two years to see how their quality of life, fatigue, and symptoms change after starting treatment. Researchers compare two drug types—BTK inhibitors and BCL-2 inhibitors—…

This study looks at how often breast cancer that has spread to lymph nodes also spreads to other parts of the body after chemotherapy and surgery. About 120 participants will get CT scans at the start and again after 6 months to check for distant cancer. The goal is to better und…

This study is testing whether a special team of doctors and scientists, called the Evolutionary Tumor Board, can come up with new treatment plans for 35 people whose cancer is considered incurable. The goal is to see if they can create a different plan than what was already avail…

This study aims to see if community education, a digital referral portal, and newsletters can increase the number of Black and Hispanic patients enrolling in cancer clinical trials at Moffitt Cancer Center. Over 7,600 community members, doctors, and staff will take part. The goal…

This study looks at 60 men with prostate cancer who had a high-risk genetic test (Decipher score >0.45). They will get a special PSMA-PET scan two years after their initial treatment to see if the cancer has spread. The goal is to learn how well the genetic test predicts early me…

This study is testing a Spanish-language cancer education program called Cancer 101 in Florida and Puerto Rico. The goal is to improve cancer awareness, screening, and research participation among Spanish-speaking adults. Up to 1,200 participants will take online modules and atte…

This study is testing whether a special team of experts, including biologists, mathematicians, and doctors, can come up with new treatment ideas for children and young adults with cancer that is unlikely to be cured by standard treatments. The team will review each patient's case…

This study is for people with pancreatic cancer. It uses artificial intelligence to find early signs of cachexia, a condition that causes severe weight loss and muscle wasting. Researchers will also see if diet and exercise programs are practical and helpful for patients. The goa…

This study is for people with pancreatic cysts or other pancreas issues. Researchers will collect blood, tissue, and scan data from over 1,100 participants to create a large database. The goal is to develop noninvasive tools that predict which cysts may become cancerous, helping …