Northwestern Lake Forest Hospital

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.

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 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.

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 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 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 evaluating the effect of adding the drug tivozanib to the immunotherapy pembrolizumab compared to pembrolizumab alone in patients with high-risk renal cell carcinoma RCC. The study aims to determine whether this combination improves disease-free survival and overall survival. This phase III trial also assesses side effects, quality of life, and collects specimens for future research in patients who have undergone surgery to remove all known kidney cancer sites. In this study, participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days of each 12-week cycle for up to 4 cycles. The other group receives the same pembrolizumab schedule combined with oral tivozanib taken daily on specific days within the 12-week cycle for up to 6 months. Throughout the trial, participants undergo blood samples, MRI or CT scans, and may have tissue biopsies. After treatment, patients are followed regularly for up to 10 years to monitor outcomes. Participants will have scheduled visits during treatment cycles and follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years. The research team measures disease recurrence or death disease-free survival as the main outcome, along with overall survival, side effects, treatment tolerance, and quality of life. Safety monitoring and quality of life assessments are included to evaluate the impact of the treatments over the long term.

Researchers are evaluating biomarker tests on tumor tissue to select personalized maintenance treatments for patients with extensive stage small cell lung cancer ES-SCLC. This phase II trial aims to determine how well these tests identify cancer subtypes and guide targeted therapies. The study also compares different maintenance treatments, including durvalumab, saruparib, ceralasertib, and monalizumab, which may affect tumor growth and immune response. Participants receive induction treatment with a platinum compound, etoposide, and durvalumab every 28 days for 4 to 6 cycles. After possible thoracic radiation, they are assigned to one of three cohorts based on cancer subtype and SLFN11 status. Each cohort is randomized to receive durvalumab alone or combined with another drug saruparib for cohort A, ceralasertib for cohort B, or monalizumab for cohort C. Maintenance cycles repeat every 28 days if disease does not progress or toxicity occurs. During the study, participants undergo imaging tests such as CT, PETCT, or MRI scans, and tissue and blood samples are collected for analysis. Researchers monitor progression-free survival and overall survival, as well as treatment safety and side effects, for up to three years. After completing study treatment, patients are followed for up to three years to assess long-term outcomes and collect specimens for future research.

Researchers are comparing two treatment approaches for patients with high anatomic stage estrogen receptor-positive, HER2-negative breast cancer who have a low risk of the cancer returning. The trial evaluates whether hormone therapy combined with the drug ribociclib works as well as chemotherapy followed by the same hormone therapy with ribociclib. Ribociclib targets enzymes needed for tumor cell growth, and hormone therapy lowers estrogen levels to help stop tumor growth. Chemotherapy works by killing or stopping the division and spread of cancer cells. Participants are first tested with the Oncotype DX assay to assess recurrence risk only those with scores between 0 and 25 continue. They are then randomly assigned to one of two groups one receives standard chemotherapy followed by hormone therapy plus ribociclib, and the other receives hormone therapy plus ribociclib without chemotherapy. Hormone therapy using letrozole, anastrozole, or exemestane is taken daily in 28-day cycles for at least five years, while ribociclib is taken daily for 21 days each cycle for up to three years. Patients undergo scans such as CT, bone scans, or PET-CT and may give blood samples during the study. Participants are followed closely with visits every 3 months during the first year, every 6 months for years 1 to 5, and annually for years 5 to 10. Researchers will assess invasive breast cancer-free survival up to 10 years and compare disease-free survival, recurrence rates, overall survival, and side effects between the two treatment groups. The study also aims to build a biorepository of tumor and blood samples for future research. This trial lasts until 2029, with ongoing monitoring to understand long-term outcomes and safety.

This trial investigates treatments for older adults newly diagnosed with acute myeloid leukemia AML who have a specific gene mutation called IDH2. It compares the combination of ASTX727 and venetoclax with or without the addition of enasidenib. The study aims to see if adding enasidenib helps more patients achieve remission by targeting the IDH2 mutation that contributes to leukemia growth. Participants are randomly assigned to one of two groups. One group receives ASTX727, an oral combination of cedazuridine and decitabine, plus venetoclax daily for 28 days in repeated 28-day cycles. The other group receives the same treatment with the addition of enasidenib every day in the cycle. Treatment continues unless the disease worsens or side effects become unacceptable. Throughout the trial, patients undergo blood and bone marrow tests to monitor their response. During the study, participants have regular blood sample collections, bone marrow aspirations, and biopsies to assess disease status and treatment effects. After completing treatment, follow-up visits occur monthly for the first year, then every two months in the second year, every three months in the third year, and every six months up to five years or until death. The main outcome measured is the rate of remission without detectable leukemia after two treatment cycles. Safety and long-term outcomes are also tracked.