Winship Cancer Center

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 studying the effects of acalabrutinib and obinutuzumab in patients with previously untreated follicular lymphoma or other indolent non-Hodgkin lymphomas. This phase II trial aims to determine the treatments effectiveness, tolerability, and impact on quality of life. The study also explores long-term outcomes such as progression-free survival and the impact of discontinuing treatment after a complete response. During the induction phase, patients take acalabrutinib orally twice daily for 28-day cycles, up to 12 cycles, in combination with intravenous obinutuzumab given on specific days during cycles 3 to 8. After 12 cycles, patients who achieve a complete response are randomized to either stop or continue acalabrutinib alone. Those with partial or stable disease continue acalabrutinib monotherapy, while patients with disease progression discontinue treatment unless benefiting as judged by their doctor. Participants undergo regular assessments including tumor measurements and patient-reported outcomes throughout treatment and follow-up visits. After completing treatment, patients are monitored at 30 days, then every 12 weeks for one year, and every 6 months thereafter until disease progression or the start of new lymphoma treatment. Researchers measure response rates, adverse events, quality of life, and survival outcomes to evaluate the treatments overall impact.

Researchers are evaluating how well a combination of cabozantinib and pembrolizumab works for patients with adrenal cortical cancer that has spread locally, to other parts of the body, or cannot be removed by surgery. This phase II trial studies cabozantinib, which may reduce tumor growth and blood vessel formation, alongside pembrolizumab, an immunotherapy that helps the immune system attack cancer cells. The goal is to see if this combination is more effective than these drugs used alone. Participants receive cabozantinib orally once daily on days 1 to 21 of each 21-day cycle. Pembrolizumab is given intravenously over 30 minutes on day 1 of each cycle. Treatment continues until the cancer progresses or side effects become unacceptable. Imaging scans like CT or MRI are done at screening and every 12 weeks during the study. Blood samples are collected at screening, during treatment, and at the end. Patients without available tumor tissue undergo a biopsy before treatment. During the study, researchers monitor tumor response using standardized criteria every 12 weeks for up to 2 years. They assess progression-free survival, overall survival, safety, and side effects for up to 2 years. After treatment ends, participants are followed for 28 days and then up to 2 years for long-term monitoring. The study also explores changes in immune cells and inflammatory markers in blood and tissue samples to better understand treatment effects.

Researchers are evaluating how well hypofractionated proton or photon radiation therapy works in treating patients with benign intracranial brain tumors, including certain meningiomas and nerve sheath tumors. This phase II trial aims to see if delivering higher doses of radiation over a shorter period can control tumors effectively while reducing delayed side effects, treatment time, and costs. The study also examines the feasibility of this approach and its effects on neurocognitive function, quality of life, and reported toxicities. Participants are assigned to one of two groups based on tumor type. Cohort I includes patients with benign radiographically diagnosed intracranial tumors who receive radiation therapy daily Monday through Friday over 17 fractions spanning 3.5 to 4 weeks. Cohort II consists of patients with pathologically confirmed WHO grade 2-3 meningiomas treated daily Monday through Friday over 20 fractions in the same time frame. Radiation may be delivered using proton or photon beams depending on the group, and treatment continues without disease progression or unacceptable toxicity. During the study, participants undergo regular follow-up visits to monitor tumor control and any adverse events for up to three years after enrollment. Researchers assess neurocognitive effects, health-related quality of life, and patient-reported toxicity throughout this period. Evaluations include imaging and questionnaires, with safety monitored closely. The total monitoring period ensures thorough observation of treatment outcomes and side effects over time.

Researchers are evaluating whether the drugs mosunetuzumab and polatuzumab vedotin can provide benefits for patients with diffuse large B-cell lymphoma or grade 3b follicular lymphoma that has returned or not responded to treatment. This study focuses on patients who have already received chemotherapy with fludarabine and cyclophosphamide, followed by CAR T-cell therapy. The goal is to determine if adding these drugs after previous treatments may better control or shrink the cancer. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by one of three CAR T-cell therapies given by infusion tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. After this, participants are randomly assigned to one of four groups receiving mosunetuzumab alone, polatuzumab vedotin alone, both drugs together, or observation without further drug treatment. Those in the observation group who experience disease progression within 12 months may switch to receive both drugs. Throughout the study, patients undergo PET-CT or CT scans and provide blood and tissue samples for research. Participants will be monitored regularly with imaging scans and laboratory tests to assess disease status and treatment effects. Researchers will measure progression-free survival, overall survival, remission rates, and treatment side effects up to two years. The study also includes collecting and banking tissue samples and PET-CT images for future research. The total length of involvement depends on individual timelines but includes treatment and follow-up periods extending up to two years or more.

Researchers are evaluating the best dose and side effects of MRX-2843 when combined with osimertinib in patients with advanced non-small cell lung cancer that has an EGFR gene mutation and spread to other parts of the body. This phase Ib trial aims to assess safety, tolerability, and identify the recommended dose for future studies, along with observing tumor response and exploring biomarkers to improve treatment effectiveness. Participants receive osimertinib and MRX-2843 orally once daily for 28-day cycles. Treatment continues as long as the disease does not progress or unacceptable side effects occur. After completing treatment, patients are followed for at least 30 days or until treatment-related side effects improve to mild levels. During the trial, participants undergo regular assessments including tumor measurements and biomarker testing. Researchers monitor safety, side effects, and treatment response over up to 3.5 years. They measure the maximum tolerated dose and progression-free survival at one year. Participants must be able to swallow oral medication and meet specific blood and organ function requirements to take part.

Researchers are studying the safety, side effects, and effectiveness of LOXO-783 in treating patients who have advanced breast cancer or other solid tumors with specific mutations in the PIK3CA gene. The study focuses on patients whose tumors carry the PIK3CA H1047R mutation or other approved activating mutations. This trial is a Phase 1 clinical trial sponsored by Eli Lilly and Company, aiming to determine safe dosing levels and understand how the drug works in these patients. Participants will receive LOXO-783 orally, either alone or combined with other anticancer drugs such as fulvestrant, imlunestrant, abemaciclib, aromatase inhibitors, or paclitaxel given by intravenous or intramuscular routes. The study includes several parts exploring different combinations and dose levels, with some groups receiving LOXO-783 alone and others receiving it with one or more additional therapies. Treatment is given sequentially according to the study design. Participants may take part in the study for up to 36 months or longer if their disease does not worsen. During this time, researchers will monitor safety by tracking dose-limiting toxicities and other side effects in the first 28 days of treatment. They will also assess how the drug behaves in the body and its effects on tumor response over time. Regular evaluations will include blood tests, tumor measurements, and other assessments to understand treatment impact and safety.

This trial studies patients with relapsed or refractory T-cell acute lymphoblastic leukemia T-ALL or T-cell lymphoblastic lymphoma T-LBL. It evaluates the safety, side effects, best dose, and effectiveness of OBI-3424, a chemotherapy drug designed to stop cancer cell growth by killing cells or preventing their division or spread. The study also explores how OBI-3424 affects disease remission and survival outcomes. Patients receive OBI-3424 intravenously over 30 minutes on days 1 and 8 of each 21-day cycle. Treatment can continue for up to 17 cycles if the disease does not progress and side effects remain acceptable. Those who do not show partial remission by the fourth cycle may be removed unless the investigator finds them clinically benefiting. The study includes blood tests, cerebrospinal fluid collection, bone marrow biopsy, and possible CT scans throughout treatment. Participants undergo screening with blood tests and provide samples during treatment. They are monitored regularly with bone marrow samples and imaging to assess disease status and treatment response. Follow-up visits occur monthly for one year, then every two months for another year, every three months for a third year, and every six months for up to five years from registration. Researchers measure the maximum tolerated dose, response rates, side effects, survival, and minimal residual disease among other outcomes.

Researchers are evaluating how a tailored survivorship care plan SCP affects understanding and access to survivorship care in Black or African American men with localized or oligometastatic prostate cancer. This study compares a standard SCP, based on American Society of Clinical Oncology guidelines, with a tailored SCP that includes a low literacy educational supplement. The goal is to address health literacy barriers that may impact patients ability to understand treatment options, side effects, and long-term health management. Participants are randomly assigned to one of two groups. One group receives the standard SCP during a provider visit and the tailored SCP with the low literacy supplement during a structured 30-60 minute interview. The other group receives only the standard SCP during a provider visit followed by a structured interview of similar duration. Both groups complete questionnaires and interviews to assess their understanding and use of survivorship care. During the study, participants comprehension of survivorship care recommendations, prostate-specific antigen surveillance, and treatment side effects will be measured at baseline and during a follow-up phone call up to 3 months later. The study also evaluates access to survivorship care, decision regret, decisional conflict, preparedness for survivorship, and patient self-efficacy. The total study duration includes initial visits and follow-up assessments, with safety monitoring and no blinding involved.

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.