Cancer Care Specialists

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are studying adolescent and young adult AYA cancer survivors who had Hodgkin or non-Hodgkin lymphoma to understand how social and genetic factors affect their health outcomes after treatment. These survivors face unique biological, clinical, psychological, and social challenges that may influence their risks for illness and early death compared to older or childhood cancer patients. The study aims to identify conditions increasing these risks and to better meet the needs of AYA cancer survivors. Participants will complete questionnaires about their quality of life and provide blood samples at the start of the study and again at 6, 12, 18, and 24 months. This observational study collects health and treatment information without administering any medical treatments. The study assesses social-environmental risks, individual resilience factors, and gene expression changes to understand their impact on survival and quality of life. Participants will be asked to fill out health-related questionnaires and provide blood samples multiple times over two years. Researchers will measure disease-free survival, overall survival, comorbidities, and quality of life during this period. The study involves ongoing monitoring through questionnaires and blood tests to gather detailed data on how social and genetic factors influence long-term outcomes for AYA lymphoma survivors.

Researchers are evaluating the effects of pembrolizumab alone compared to the standard treatment of chemotherapy cisplatin or carboplatin combined with radiation therapy after surgery in patients with recurrent or second primary head and neck squamous cell carcinoma. This phase II trial aims to assess overall survival, disease control, metastasis rates, and side effects in high-risk patients, while also exploring whether high PD-L1 expression predicts better responses to pembrolizumab. Participants are randomly assigned to one of two treatment groups. One group receives intravenous cisplatin or carboplatin weekly for six cycles alongside daily intensity-modulated radiation therapy or proton beam radiation totaling 30 sessions. The other group receives intravenous pembrolizumab every six weeks for up to nine cycles. Throughout treatment, participants undergo CT or MRI scans to monitor their condition. After completing treatment, participants are followed up 30 days later and then every six months for up to five years. During the study, researchers evaluate overall survival from randomization to death, adverse events for up to five years, disease-free survival, and PD-L1 expression levels. The study monitors patients closely with imaging and clinical assessments to track treatment effects and safety over time.

Researchers are evaluating a text-based program designed to help rural cancer survivors who smoke to quit smoking. This phase III trial compares an eight-week scheduled gradual reduction SGR intervention delivered via personalized text messages combined with the National Cancer Institutes Smokefree.TXT service to a control group receiving a smoking cessation booklet. The study aims to assess how effective these approaches are in achieving biochemically validated smoking cessation six months after quitting, as well as their impact on quality of life. Participants are randomly assigned to one of two groups. The first group follows a personalized eight-week gradual reduction schedule, supported by cessation messages sent by text for 12 weeks. The second group receives the NCI Clearing the Air booklet to assist in planning gradual smoking cessation. After completing the interventions, participants are followed for a total of six months post-quit date to evaluate outcomes. During the study, participants will provide urine samples and complete questionnaires to measure smoking status and quality of life at baseline, 30 days, and six months after quitting. The research team uses biochemical validation to confirm smoking cessation. Participants must have texting capability on a cell phone or smartphone and be able to read and speak English. The total participation includes the intervention period plus follow-up to monitor smoking cessation and quality of life changes.

This research aims to evaluate how well amivantamab given by subcutaneous injection works in treating patients with advanced non-small cell lung cancer that has extra copies of the MET gene. This phase II Expanded Lung-MAP treatment trial focuses on patients with MET amplification-positive non-small cell lung cancer. The goal is to see if amivantamab-SC can reduce tumor growth or spread by targeting the extra MET gene copies in these tumors. Participants receive amivantamab subcutaneously on days 1, 8, 15, and 22 during the first 28-day cycle, then on days 1 and 15 of subsequent 28-day cycles as long as the disease does not progress or unacceptable side effects occur. Throughout the trial, patients have regular CT or MRI scans and blood samples taken to monitor treatment effects and disease status. After completing treatment, patients are followed for up to 3 years to assess long-term outcomes. During the study, researchers evaluate how many patients respond to the treatment, how long responses last, progression-free survival, overall survival, and the frequency and severity of side effects. Blood samples are collected before treatment, during therapy, and at disease progression to study tumor DNA and build a tissue and blood repository. Safety labs, physical exams, and performance status assessments are also conducted. The total participation can last up to 3 years including follow-up.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.

Researchers are investigating targeted therapies directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread or progressed after standard treatments. This Phase 2 screening trial, called ComboMATCH, aims to match patients to specific combination treatments based on genetic mutations found in their tumor cells. The study seeks to improve treatment planning by using genetic information to guide therapy choices. Patients undergo tumor genetic screening using previously collected samples or a new biopsy if eligible and aged 18 or older. Based on their tumors genetic profile, patients are assigned to one of multiple treatment subprotocols involving different drug combinations. Treatments include oral, intravenous, and intramuscular drugs such as selumetinib, olaparib, fulvestrant, binimetinib, and others. Treatment cycles generally repeat every 28 days until disease progression or unacceptable toxicity. Patients may also undergo biopsies, blood collection, imaging scans CT, MRI, PET, echocardiograms, and bone marrow procedures as part of the study. Throughout the trial, participants have regular assessments including tumor biopsies, blood draws, imaging tests, and heart function monitoring. These evaluations occur during screening, treatment, and follow-up periods. Researchers measure patient enrollment, assignment to treatment arms, and treatment outcomes over up to 8 years. Safety is monitored via clinical evaluations and diagnostic tests. This comprehensive approach aims to evaluate responses to targeted therapies guided by tumor genetics for advanced solid tumors.

Researchers are evaluating treatment options for patients newly diagnosed with multiple myeloma who are considered frail or intermediate-fit and who are not candidates for stem cell transplant. This phase III trial compares three different three-drug induction regimens followed by either single or double drug maintenance therapies. The study aims to find which drug combination best controls the cancer and improves patient outcomes while considering patients age, other health conditions, and physical function. Participants are randomly assigned to one of three treatment arms. In Arm 1, patients receive bortezomib, lenalidomide, and dexamethasone with bortezomib given subcutaneously and the others taken orally for up to 9 cycles, followed by lenalidomide maintenance. Arm 2 involves daratumumab with hyaluronidase-fihj given subcutaneously, lenalidomide, and dexamethasone for induction, followed by lenalidomide maintenance. Arm 3 includes the same induction as Arm 2, but maintenance therapy combines daratumumab with hyaluronidase-fihj and lenalidomide. Each cycle lasts 28 days, and treatment continues without disease progression or unacceptable side effects. During the trial, participants undergo regular assessments including tumor measurements, blood tests, and quality-of-life questionnaires. Researchers monitor progression-free survival, overall survival, response rates, minimal residual disease status, and patient-reported symptoms and health status. After completing treatment, patients are followed up every 3 months for one year, every 6 months for two years, and then annually for up to 10 years to monitor long-term outcomes and safety.