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 tumor DNA. The goal is to train the immune system to recognize and attack any remaining breast cancer cells after standard chemotherapy and surgery. The study enrolls 16 people with high-risk triple neg…

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 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 continuous dosing but with fewer side effects. About 34 adults with confirmed advanced…

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 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 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 or II disease will receive the drug every three weeks for up …

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 study tests a new treatment for advanced melanoma that has not responded to standard therapies. Doctors take immune cells from a patient's tumor, boost them with a molecule called CD40L, and return them to the patient after a short course of chemotherapy. The goal is to see …

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 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 study tests a mindfulness-based program designed to help cancer survivors stop smoking and reduce heavy drinking. About 600 participants in Florida will be assigned to either the mindfulness program or standard care. The goal is to see if the program leads to more people qui…

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 study tests whether a smartphone program that sends personalized text messages, along with nicotine patches, can help people with HIV who smoke to quit. Researchers will enroll 800 smokers in Cambodia and track their progress over 6 months. The goal is to find a simple, low-…

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 phase 2 trial tests whether adding the targeted drug pirtobrutinib to standard CAR-T cell therapy (brexucabtagene autoleucel) helps people with mantle cell lymphoma that has returned or stopped responding to treatment. About 60 adults will be randomly assigned to receive pir…

This study tests a CAR T-cell therapy called KTE-X19 in 60 adults with B-cell acute lymphoblastic leukemia (B-ALL) who are in remission but still have minimal residual disease (MRD) — tiny traces of cancer that standard tests miss. The goal is to see if this one-time infusion can…

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-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-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 tests a combination of two drugs, rituximab and zanubrutinib, in people with untreated follicular lymphoma or marginal zone lymphoma. The goal is to see if the combination is safe and effective at shrinking or controlling the cancer. About 43 participants will receive …

This study tests a combination of two drugs, tafasitamab and lenalidomide, in people with large B-cell lymphoma that still shows signs of disease after CAR-T cell therapy. The goal is to see if this drug pair can shrink or eliminate the remaining cancer. About 28 adults will take…

This study looks at whether adults with acute myeloid leukemia (AML) whose cancer is well-controlled after a year of chemotherapy can stop treatment for a while without their disease coming back. About 37 participants will pause their medication and be monitored closely. The goal…

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 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 study is for people with a specific type of breast cancer (HR+/HER2-) that has spread to the brain. It tests whether adding a targeted drug called abemaciclib to precise radiation therapy can better control the brain tumors. About 31 participants will receive both treatments…

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 early-phase trial tests a new treatment for men with advanced prostate cancer that has spread to the bone and no longer responds to standard therapies. The treatment involves taking a patient's own immune cells (gamma delta T cells), modifying them in a lab to better recogni…

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 early-phase study tests whether adding aspirin to standard chemotherapy can reduce immune-suppressing cells inside ovarian tumors. About 100 women with ovarian, fallopian tube, or peritoneal cancer will take aspirin alongside chemo before surgery. Researchers will compare tu…

This study tests whether taking itacitinib pills before CAR-T cell therapy can help people with diffuse large B-cell lymphoma live longer without their cancer growing. About 27 adults who are eligible for CAR-T treatment will receive itacitinib once daily before their standard CA…

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 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 study tests whether adding a targeted drug (sacituzumab govitecan) and an immunotherapy (zimberelimab) to precise brain radiation can help people with metastatic triple negative breast cancer that has spread to the brain. About 31 adults will receive the combination and be m…

This study tests whether adding an immune-boosting vaccine (Sipuleucel-T) to ongoing hormone therapy can better activate the immune system in men with metastatic prostate cancer that has started to progress. About 26 men whose cancer is growing despite standard hormone treatments…

This study tests a new way of giving already-approved drugs to people with hormone-positive metastatic breast cancer. The idea is to use a 'first strike, second strike' approach, inspired by how extinctions happen in nature, to make the treatment more effective. The study will en…

This early-phase study tests the safety of combining two chemotherapy drugs, CPX-351 and gemtuzumab ozogamicin, in 18 adults aged 18–70 with newly diagnosed acute myeloid leukemia (AML). The goal is to find the highest safe dose and see how many patients achieve complete remissio…

This study tests a combination of three immunotherapy drugs (IL2, ipilimumab, and nivolumab) in people with advanced melanoma that can't be removed by surgery and has stopped responding to prior anti-PD1 treatment. The goal is to see if this new approach can shrink tumors or slow…

This study tests whether combining axitinib (a targeted therapy) with ipilimumab (an immunotherapy) can shrink tumors or slow disease in people with advanced melanoma that has stopped responding to standard treatment. About 25 adults with unresectable melanoma will receive both d…

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 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 study tests whether adding venetoclax to standard chemotherapy (CLAG-M) helps adults with relapsed or refractory acute myeloid leukemia (AML) achieve deeper remission and live longer without the cancer returning. About 52 participants will be randomly assigned to receive eit…

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 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 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 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 tests whether adding the drug elranatamab after CAR-T cell therapy can help people with high-risk relapsed myeloma live longer without their cancer getting worse. About 39 participants who have already received CAR-T will receive elranatamab as maintenance. The goal is…

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 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 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 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 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 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 tests whether MRI scans can help doctors adjust radiation therapy for head and neck cancer patients to better protect healthy organs like salivary glands and the throat. About 35 adults with certain types of head and neck cancer will receive standard radiation plus an …

This study tests a program that gives extra nutrition help to people with pancreatic cancer after they have surgery. The program uses a mobile app and remote dietitian support to help patients eat well during recovery. The goal is to see if the program is easy to use and helps pa…

This study tests whether a remote exercise and nutrition program can help people with pancreatic cancer get stronger before surgery. Researchers want to see if the program is practical and acceptable for patients. The study will enroll 26 adults who are scheduled for surgery afte…

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 offers a free online cancer education program called Cancer 101 in Spanish and English. It is designed for adults 18 and older in Florida and Puerto Rico. The goal is to increase cancer knowledge, encourage screening, and involve communities in research.

This study looks at whether getting a brain MRI every 6 months can find cancer spread to the brain earlier in people with stage IV breast cancer who have no symptoms. About 156 participants will be randomly assigned to either scheduled scans or scans only when symptoms appear. Th…

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 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 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 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 looks at whether regular brain MRIs can detect cancer that has spread to the brain in people with stage IV breast cancer who have no brain symptoms. About 170 participants with different breast cancer types will get brain scans at the start and again after 6 months or …

This study is creating a smartphone-based system to help cancer patients stop smoking. Researchers will test if the tool is easy to use and if patients like it. About 90 adult cancer patients who smoke will take part. The goal is to make this resource available to researchers acr…

This study follows 100 adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) to see how their quality of life, fatigue, and symptoms change over 2 years after starting treatment. Researchers compare two common treatment types to help future patients k…

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 …

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 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 whether a group of specialists from different hospitals can come up with new treatment ideas for children and young adults with cancer that is very hard to cure. The team will review each patient's case and suggest a different approach than what their own do…