Brunswick

Researchers are evaluating the effects of adding cemiplimab, an immunotherapy drug that blocks the PD-1 pathway to help the immune system attack tumor cells, to the usual treatment of docetaxel and ramucirumab in patients with stage IV or recurrent non-small cell lung cancer. This phase II/III Expanded Lung-MAP trial compares cemiplimab combined with docetaxel and ramucirumab versus docetaxel and ramucirumab alone, aiming to improve treatment outcomes in patients who previously received platinum chemotherapy and immunotherapy but developed resistance or disease progression. Participants are randomly assigned to one of two treatment arms. In Arm I, patients receive dexamethasone orally twice daily on days 0-2, ramucirumab and docetaxel intravenously on day 1 of each 21-day cycle. In Arm II, patients receive the same treatments plus cemiplimab intravenously on day 1 of each cycle. Treatment cycles continue every 21 days until disease progression or unacceptable side effects occur. Throughout the study, patients undergo regular blood sample collection and imaging scans such as CT or MRI to monitor disease status. During the study, participants are closely monitored with scans, blood tests, and physical exams to assess overall survival and other outcomes like progression-free survival, response rates, and treatment safety. Researchers also collect blood samples for future molecular studies. After completing treatment, patients are followed up every 3 to 6 months for up to 3 years to track long-term survival and health status. The study measures overall survival from randomization to death from any cause, assessed up to 3 years.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating treatment options for older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients unfit for standard treatment who have a mutation in the IDH2 gene. This phase II trial compares the effectiveness of ASTX727 and venetoclax alone versus ASTX727, venetoclax, and enasidenib combined. The goal is to see if adding enasidenib can improve the rate of complete remission without measurable residual disease in this patient group. Participants are randomly assigned to one of two treatment groups. One group receives ASTX727 orally once daily on days 1 to 5 and venetoclax orally once daily on days 1 to 28 of each 28-day cycle. The second group receives the same treatment plus enasidenib orally once daily on days 1 to 28 of each cycle. Treatment continues in 28-day cycles until disease progression or unacceptable side effects occur. Throughout the trial, patients undergo blood sample collection, bone marrow aspiration, and biopsy. During the study, participants have regular assessments including blood tests, bone marrow evaluations, and monitoring for side effects. After treatment ends, follow-up visits occur monthly for the first year, every two months in the second year, every three months in the third year, and every six months until five years after enrollment or death. The primary outcome measured is the rate of complete remission without measurable residual disease from baseline up to five years after treatment begins.

Researchers are evaluating a mentorship and education program called COACH-APP designed to improve advanced practice providers' (APPs) confidence in participating in clinical research, known as research self-efficacy. APPs are skilled clinicians who work regularly on cancer care teams but may not be routinely involved in research at community oncology sites. The program aims to help APPs integrate more fully into research teams, potentially enhancing patient care and access to clinical trials within the National Cancer Institute Community Oncology Research Program (NCORP) network. The study compares APPs who receive the COACH-APP intervention, which includes focused education and structured mentorship, to an education control group. Participants in the intervention gain access to the SWOG APP Clinical Research workshop and the Advanced Practice Provider Clinical Trials Research Manual, along with mentorship support. The trial also includes surveys and interviews as ancillary studies to assess the program's acceptability, feasibility, and impact on research team functioning and patient care. During the 12-month study period, APPs participate in educational workshops, mentorship activities, and complete surveys. Researchers assess changes in research self-efficacy from baseline to 12 months after randomization. They also evaluate APP engagement with NCORP, integration into research care teams, and practice-level study activity over 24 months. Selected participants and mentors are interviewed to explore perceptions of the intervention and identify barriers and facilitators to APP research involvement.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating an online educational program called Current Together After Cancer (CTAC) designed to help patients who have had surgery for stage II or III colorectal cancer receive follow-up care that follows current medical guidelines. This phase III trial aims to see if CTAC improves patients' knowledge about surveillance, their confidence in managing their care, and satisfaction with support received from a chosen adult supporter. Proper surveillance after colorectal cancer surgery is important to detect any return of the disease early, but many survivors do not receive recommended follow-up care, possibly due to lack of information or support. Participants are randomly assigned to one of two groups. One group receives access to the CTAC intervention website, which includes educational content and interactive modules to help manage post-surgery surveillance. The other group accesses a control website with general health education. Both patients and their chosen supporters can use their assigned website as often as they like for up to 16 months. Supporters are adult individuals identified by the patient who help with their cancer journey. During the study, researchers will measure how many patients receive surveillance care that follows guidelines at 12 and 16 months. They will also assess patients' knowledge about surveillance, confidence in managing their care, and satisfaction with supporter involvement at 3 and 16 months. Surveys and interviews will be conducted to gather this information. The study will also explore how well the intervention fits into clinical practice and how supporter participation affects outcomes.

Researchers are evaluating whether high-dose gabapentin can prevent the need for opioid pain medication during chemoradiation therapy in patients with squamous cell carcinoma of the head and neck. Oral mucositis, a common side effect of radiation, causes severe pain and complications that often require opioid treatment, which has many side effects. This phase III trial aims to see if gabapentin can reduce opioid use and improve pain management in this patient group. Participants are randomly assigned to receive either gabapentin or a placebo starting with radiation treatment day 8. The dosing increases from once daily on day 1 to three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain medications as needed. Treatment continues until oral mucositis symptoms lessen and opioid use stops, followed by a gradual dose reduction over 11 days. Blood samples are collected throughout the study. Patients are followed up at 4 weeks, 3 months, and 6 months after completing chemoradiation therapy. Researchers measure the need for opioid use during treatment, time to first opioid use, patient-reported pain scores, quality of life, symptom outcomes, adverse events, tolerance to gabapentin, body mass index, lab results, feeding tube use, and opioid dosing. This comprehensive approach helps assess the effectiveness and safety of gabapentin in preventing opioid use for oral mucositis pain.

Researchers are evaluating a Master Screening and Reassessment Protocol (MSRP) called myeloMATCH for people with myeloid cancers such as acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This Phase 2 study aims to improve how patients are matched to clinical trials or standard treatments by testing bone marrow and blood samples for specific biomarkers. These markers help doctors understand the cancer's characteristics and identify targeted treatments or assign patients to a standard of care treatment pathway called the Tier Advancement Pathway (TAP). Participants undergo bone marrow aspiration and blood collection for rapid genetic testing to identify mutations that guide treatment assignment. Based on these results, patients are placed into treatment substudies targeting their cancer type or, if no targetable mutation is found, into TAP to receive standard care with ongoing monitoring. The study includes multiple treatment arms with various drug regimens such as azacitidine, venetoclax, daunorubicin, cytarabine, and others, delivered through intravenous, subcutaneous, or oral routes. Some participants may receive hematopoietic stem cell transplants and conditioning therapies. Treatment cycles generally repeat every 21 to 28 days, with adjustments based on response and tolerance. Throughout the trial, participants undergo regular assessments including bone marrow biopsies, blood tests, imaging scans (such as chest x-rays, CT, PET, echocardiography, and MUGA scans), and specimen collection for translational medicine and biobanking. The study monitors treatment assignment timing, response rates, remission status, measurable residual disease, survival outcomes, and safety. Participants remain on study for ongoing reassessment and potential assignment to higher-tier treatments or TAP. The protocol requires informed consent and continues as long as disease progression or unacceptable toxicity does not occur.

Researchers are evaluating whether 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy is as effective as 12 months of the same treatment for patients with early-stage HER2-positive breast cancer who have no remaining invasive cancer after preoperative chemotherapy with trastuzumab. This phase III trial focuses on patients who achieved a pathologic complete response (pCR), aiming to assess recurrence-free survival and quality of life outcomes. The study also explores differences in side effects and survival among subgroups based on treatment delivery and hormone receptor status. Participants are randomly assigned to receive either 6 or 12 months of HER2-targeted therapy, including trastuzumab and possibly pertuzumab, administered intravenously or subcutaneously every 21 days. The treatment cycles continue up to 9 or 17 cycles respectively, unless disease progression or unacceptable side effects occur. Throughout the trial, patients undergo regular heart function tests (echocardiography or MUGA), breast imaging (mammography, ultrasound, or MRI), and may optionally provide blood and tissue samples. During the study, patients complete quality of life questionnaires and are monitored for cancer recurrence and side effects. Follow-up visits occur every 6 months for 5 years and then annually up to 10 years after registration. The main outcomes measured include time without cancer recurrence and patient-reported quality of life at 12 months. Safety and long-term effects of the different treatment durations are also assessed.