Medical Oncology Hematology Consultants

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 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.

This trial studies newly diagnosed multiple myeloma in participants who are not candidates for stem cell transplant. It compares the effects of two drug combinations teclistamab with daratumumab and lenalidomide Tec-DR, and talquetamab with daratumumab and lenalidomide Tal-DR, against the standard treatment of daratumumab, lenalidomide, and dexamethasone DRd. The goal is to assess how these combinations affect disease progression and treatment response. Participants are randomly assigned to one of three groups receiving either Tec-DR, Tal-DR, or DRd. Teclistamab and talquetamab are given as subcutaneous injections, daratumumab is given subcutaneously, lenalidomide is taken orally, and dexamethasone can be given orally or intravenously. Treatments are administered according to the study protocol over an extended period, with follow-up lasting up to nine years to monitor outcomes. During the study, participants undergo regular evaluations including disease progression monitoring, minimal residual disease status at 12 months, and assessments of response levels. Researchers also track survival, adverse events, laboratory and vital sign changes, quality of life, and drug concentrations. The study involves multiple visits for treatment and assessment to carefully evaluate the long-term impact of these drug combinations on patient health and disease control.

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 dose-escalated radiation therapy compared to usual care for patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have already completed 4 to 6 months of chemotherapy. The study is a phase III trial aiming to determine if higher doses of radiation can improve 3-year overall survival, as well as assess effects on tumor progression, chemotherapy-free intervals, treatment toxicity, and quality of life. This trial is led by NRG Oncology and focuses on patients without disease progression after initial chemotherapy. Participants are randomly assigned to one of two groups. The first group receives standard care, which may include additional chemotherapy options such as FOLFIRINOX, NALIRIFOX, or gemcitabinenab-paclitaxel, standard radiation therapy with concurrent chemotherapy, or observation. The second group receives dose-escalated radiation therapy delivered in either 5 or 25 fractions, with or without concurrent chemotherapy for the 25-fraction option. After radiation, patients who have not completed 6 months of chemotherapy are encouraged to finish it, with treatment beyond 6 months at the physicians discretion. Imaging and tissue biopsies are performed throughout the study. Participants undergo various assessments including blood sample collection, CT scans, MRI, and optional PETCT scans before and during treatment. Tumor tissue biopsies are also collected. Follow-up visits occur every 3 months for the first 2 years and annually for an additional 3 years. Researchers measure overall survival, local disease progression, progression-free survival, chemotherapy-free intervals, and adverse events. Quality of life is evaluated using specific questionnaires over the course of participation.

Researchers are evaluating the effectiveness and safety of two combination treatments for adults with hormone receptor positive HR, human epidermal growth factor receptor 2 negative HER2- locally advanced or metastatic breast cancer that has a PIK3CA mutation. These patients have experienced recurrence or progression after treatment with a CDK46 inhibitor. This Phase 3, open-label, randomized study compares RLY-2608 zovegalisib plus fulvestrant against capivasertib plus fulvestrant to determine which treatment better controls the disease. Participants are assigned to one of two groups one group receives zovegalisib orally twice daily along with fulvestrant administered by injection on specific days during a 28-day treatment cycle the other group receives capivasertib orally twice daily on an intermittent weekly schedule plus fulvestrant injections on the same schedule. Treatment cycles repeat every 28 days. The study is conducted globally at multiple centers and continues until disease progression or other criteria are met. During the study, participants undergo regular assessments including scans reviewed by blinded independent central review to measure progression-free survival, as well as monitoring overall survival, response rates, quality of life questionnaires, and safety evaluations. Blood samples are taken periodically to measure drug levels. The study may last up to approximately 77 months for outcome measurements, with ongoing monitoring for adverse events and quality of life changes throughout this period.

This trial investigates the addition of panitumumab to standard chemotherapy for patients with KRAS wild type pancreatic ductal adenocarcinoma that cannot be removed by surgery or has spread locally or to other parts of the body. The study aims to compare overall survival and other clinical outcomes between patients receiving panitumumab plus chemotherapy and those receiving chemotherapy alone. It also evaluates quality of life, treatment toxicity, and patient-reported symptoms. Participants are randomly assigned to one of two groups. One group receives panitumumab intravenously on days 1 and 15, combined with one of several chemotherapy regimens given intravenously in 28-day cycles, repeating if tolerated without disease progression. The other group receives the same chemotherapy regimens without panitumumab, also in 28-day cycles. Throughout the study, patients undergo CT scans and blood sample collection. After treatment, they are followed for up to three years. During the study, participants will have regular imaging and blood tests to monitor disease status and treatment effects. Quality of life and symptom questionnaires are completed at specified intervals. Researchers measure overall survival, progression-free survival, response rates, duration of response, and treatment side effects. Safety is monitored up to 30 days after treatment ends. Specimens are banked for future research, and patient-reported outcomes help assess the impact of treatment over 24 weeks.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are comparing two treatment approaches for patients with high-grade T1 non-muscle invasive bladder cancer. This phase II trial evaluates pembrolizumab combined with radiation therapy against standard chemotherapy regimens plus radiation. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells, while chemotherapy drugs work to kill or stop tumor cells from growing and spreading. Radiation therapy uses high-energy rays or particles to destroy cancer cells and shrink tumors. Participants are randomly assigned to one of two treatment groups. One group receives chemotherapy chosen by their doctor, which may include cisplatin, gemcitabine, or a combination of mitomycin and 5-fluorouracil, along with radiation therapy delivered over 4 to 7 weeks. The other group receives pembrolizumab infusions every 6 weeks for up to 9 cycles, also combined with radiation therapy over the same period. Both groups undergo imaging scans and blood tests during treatment, with optional urine samples collected. After finishing treatment, participants are followed regularly for up to 10 years, with more frequent check-ups in the first 2 years and less frequent visits afterward. The study measures bladder-intact event-free survival and quality of life over 5 years, along with assessing tumor response, disease control, survival rates, side effects, fatigue, and other quality of life factors. Researchers aim to understand the long-term effects of these treatments and monitor patient safety throughout the study.