Clinical Research Directory

Machine Learning to Analyze Facial Imaging, Voice and Spoken Language for the Capture and Classification of Cancer/Tumor Pain

Background: Cancer pain can have a very negative effect on people s daily lives. Researchers want to use machine learning to detect facial expressions and voice signals. They want to help people with cancer by creating a model to measure pain. They want the model to reflect diverse faces and facial expressions. Objective: To find out whether facial recognition technology can be used to classify pain in a diverse set of people with cancer. Also, to find out whether voice recognition technology can be used to assess pain. Eligibility: People ages 12 and older who are undergoing treatment for cancer Design: Participants will be screened with: Cancer history Information about their sex and skin type Information about their access to a smart phone and wireless internet Questions about their cancer pain Participants will have check-ins at the clinic and at home. These will occur over about 3 months. They will have 2-4 check-ins at the clinic. They will check in at home about 3 times per week. During check-ins, participants will answer questions and talk about their cancer pain. They will use a mobile phone or a computer with a camera and microphone to complete a questionnaire. They will record a video of themselves reading a 15-second passage of text and responding to a question. During the clinic check-ins, professional lighting, video equipment, and cameras will be used for the recordings. During remote check-ins, participants will be asked to complete the questionnaire and recordings alone. They should be in a quiet and bright room. The room should have a white wall or background. ...

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Advanced Cancers

The Primary purpose of this study is to identify the recommended Phase 2 dose \[RP2D(s)\] for JNJ-63723283 in Part 1, to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2, to determine one or more additional RP2Ds in Parts 3 and 4.

Data Collection, Clinical Care and Interventions in CCR, NCI

This study provides cancer care through the National Cancer Institute's Medical Oncology Branch (MOB) to patients who are not enrolled in an active treatment research protocol. Patients receive standard treatments only; no investigational therapies are provided on this protocol. Patients 18 years of age and older may be eligible for this protocol. Candidates are patients for whom an NCI investigator decides that the interests of the patient and the NCI are best served by the patient's enrollment in this protocol to receive care and follow-up within the MOB. This includes patients in the following categories: * Patients previously enrolled in NCI trials whose participation in this protocol may continue to provide researchers important scientific information * Patients who will be eligible for a research protocol within the foreseeable future * Patients whose medical welfare will be seriously compromised by referral back to the community, such as patients with a rare or complex disease for which community resources are inadequate or unavailable * Terminally ill patients who have received most of their specialized medical care at the Clinical Center and for whom humanitarian considerations dictate that they continue to receive their medical care at NIH after going off study for the remaining weeks or months of life * Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer treatments at the NCI are requested through the MOB consult service * Patients who are participating in a non-treatment NCI research protocol and require standard-of-care therapy * Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or management at the NCI would add significant value to the institute's cancer training program Participants receive standard medical care, including periodic routine laboratory tests, diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the effects of any treatment.

Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing. Objective: To test TriAdeno and N-803 in people with early-stage prostate cancer. Eligibility: People aged 18 years and older with early-stage low- or medium-risk prostate cancer. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam. TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle. Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms. Blood tests, imaging scans, and other tests will be repeated during the study. A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later. Participants will have follow-up phone calls for 5 years....

A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors

The goal of this clinical trial is to learn if investigational agent LRK-4189 works to treat solid tumors in adults, with a focus on colorectal cancer. It will also learn about the safety of drug LRK-4189. The main questions it aims to answer are: Is LRK-4189, administered alone or in combination with standard chemotherapy regimens, safe and tolerable in patients with solid tumors? Participants will: * Take investigational agent LRK-4189 alone or in combination with standard chemotherapy regimens every day for up to 3 years. * Visit the clinic once every week for checkups and tests.

Clinical and Genetic Studies of Li-Fraumeni Syndrome

Background: \- Li-Fraumeni syndrome (LFS) is a genetic condition that increases the risk for some types of cancer. LFS may lead to cancer of the bone or connective tissue, breast, and brain. It may also increase the risk for certain types of leukemia and other cancers. The only known cause of LFS is a change (called a mutation ) in a gene known as TP53. However, not all people with LFS have a TP53 mutation. Researchers want to study other possible genetic causes of LFS, and factors that may increase or decrease cancer risk in people with the syndrome. Objectives: * To learn more about the types of cancers that occur in individuals with LFS. * To study the role of the TP53 gene in the development of cancer. * To look for other possible genes that cause LFS * To study the effect of LFS diagnosis on families. * To determine if environmental factors or other genes can change a person s cancer risk associated with LFS. Eligibility: * Individuals with a family or personal medical history of cancers consistent with LFS. * Individuals with a family or personal medical history of cancers that does not meet the diagnosis of LFS, but the history is suggestive for LFS (meets the diagnosis for the so-called Li-Fraumeni like syndrome) * Individuals with certain rare cancers * Individuals with a family or personal history of a TP53 gene mutation, with or without related cancer(s). Design: * Participants will fill out a medical history questionnaire and a family history questionnaire. * Blood samples will be collected for DNA and for storage. Cheek cell samples may be collected if blood cannot be obtained for DNA. Participants can choose to have or not have cancer screening with blood tests, imaging studies, and other exams. * Participants will complete questionnaires about their worries about cancer, stress levels, and coping strategies. Diet and physical activity questionnaires will also be given. Other psychological tests may be given as needed. * Participants will be monitored for several years, with regular followup visits to the National Institutes of Health, if indicated. Any changes in health or cancer status will be recorded.

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors

Background: Blood, tissue, and tumor cells contain genes. Genes are made up of DNA. DNA is the "instruction book" for each cell. In some people with cancer, the genes that might have slowed the growth of their tumor were "turned off." Researchers want to see if a new drug can turn the genes back on and slow the tumor growth. The drug is called Aza-TdC. Objective: To test the safety of Aza-TdC, and to find out the dose of this drug that can be safely given to humans. Eligibility: People ages 18 and older who have advanced cancer that has gotten worse after standard treatment, or for which no effective therapy exists Design: Participants will be screened with: Medical history Blood and urine tests Scans to measure their tumors Test to measure the electrical activity of the heart Participants will take the study drug by mouth. The drug is given in cycles. Each cycle is 21 days (3 weeks) long. Week 1 and week 2: participants will take the study drug once a day for 5 days. Then they will have 2 days without the drug. Week 3: no study drug is taken. This completes one cycle of treatment. For cycle 1, participants will repeat the screening tests several times. For all other cycles, participants will have blood tests and pregnancy tests. They will have scans of their tumor every 6 weeks. The cycle will be repeated as long as the participant tolerates the drug and the cancer is either stable or gets better. Sponsoring Institute: National Cancer Institute ...

Psychological Support and Psycho-Emotional Trajectories in Cancer Genetics.

Undergoing a cancer genetic testing pathway and receiving results regarding a personal or familial cancer predisposition can generate substantial, multifaceted psycho-emotional distress for patients. While professional psychological support is strongly recommended in clinical guidelines, very few studies have formally quantified its actual contribution to the longitudinal psycho-emotional experiences of patients within real-world clinical practices. The primary objective of the PsyOncoGen study is to describe the longitudinal psycho-emotional trajectories of patients within the routine care pathway. It evaluates the clinical impact of psychological support by observing the natural outcomes of patients who choose to accept this systematically offered service versus those who choose to decline it. The study will follow 220 adult patients across two natural cohorts determined solely by patient choice: 110 patients utilising the clinical psychological support and 110 patients declining it.

Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members

This study will collect biological samples for use in research experiments aimed at better understanding the clinical features of certain diseases. The specimens may be used to evaluate the effectiveness of known therapies, refine treatment approaches, identify potential new therapies, and explore opportunities for disease prevention. The following individuals 2 years of age or older may be eligible for this study: * Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center * HLA-compatible donor family members (18 years of age or older) of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor * Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider. Research samples will be collected from participants when blood is drawn or bone marrow, urine, or stool is collected, or tumor or other tissue is biopsied as part of their general medical care. Investigators may periodically request an additional sample of blood, stool, or urine. Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis. This procedure is not part of general medical care and would be done for research purposes only. For apheresis, a catheter (plastic tube) is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator machine, where the white cells are separated from the red cells, platelets, and plasma by a spinning process. The white cells are removed and collected, and the rest of the blood is returned to the subject through a second tube placed in the other arm. ...

Registry Study for Radiation Therapy Outcomes

The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.

AI-Driven Tumor Response Evaluation for Solid Tumors

Purpose: This study is developing and validating an artificial intelligence (AI)-driven system to evaluate tumor response using changes in total tumor volume. The goal is to determine whether this AI-based approach can better predict patient survival compared with the current standard method (RECIST), which relies on linear measurements of a few selected tumors. Participants: The study includes both retrospective and prospective cohorts. The retrospective cohort includes approximately 6,000 patients with solid tumors who received non-surgical treatment between 2015 and 2025. The prospective cohort will enroll approximately 120 patients starting in mid-2026. Study details include: Study Duration: Approximately 3 years Participation Duration: Up to 6 months for prospective participants; retrospective participants contribute existing medical records only Visit Frequency: For prospective participants, follow-up visits occur every 3 months (up to 6 months) aligned with routine clinical care Intervention: None. This is an observational study using routine clinical imaging (CT/MRI) and medical records Primary endpoints: Overall survival (OS) and progression-free survival (PFS). The study will also evaluate the feasibility and impact of AI-assisted tumor response reporting on clinical workflow and patient understanding. Participants in the prospective cohort will receive either a standard RECIST report or an AI-assisted dynamic tumor response report. This comparison is for research purposes only and does not alter standard medical care.

Resilience in East Asian Immigrants for Advance Care Planning Discussions

The purpose of the study is to develop a culturally tailored digital resilience-building intervention to help East Asian immigrants engage in advance care planning discussions with their family caregivers.

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.

Study of CD30 CAR for Relapsed/Refractory CD30+ HL and CD30+ NHL

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been sufficient to cure most patients. This study is designed to combine both T cells and antibodies to create a more effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration. In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. The purpose of this research study is to establish a safe dose of ATLCAR.CD30 cells to infuse after lymphodepleting chemotherapy and to estimate the number patients whose cancer does not progress for two years after ATLCAR.CD30 administration. This study will also look at other effects of ATLCAR.CD30 cells, including their effect on the patient's cancer.

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.

A Study of JNJ-1761981 in Participants With Solid Tumors

The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions.

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.

A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring

The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC).

A Study of JNJ-87890387 for Advanced Solid Tumors

The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 at the RP2D(s).

A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.

An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)

This is an open-label, multicenter, non-randomized extension study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and do not have access to the study treatment locally, continue to receive study treatment in this extension study.

Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies

This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and/or optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.