Elizabethtown

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating the use of dexamethasone mouthwash as a preventive treatment for stomatitis related to Datopotamab Deruxtecan Dato-DXd in patients with metastatic or inoperable locally recurrent breast cancer or advanced or metastatic EGFR-mutated non-small cell lung cancer. This Phase IV, open-label, single-arm study aims to describe how often and how severe grade 2 or higher stomatitis occurs in participants receiving this prophylactic mouthwash during the first 12 weeks of Dato-DXd treatment. Participants will receive dexamethasone 0.5 mg5 mL alcohol-free mouthwash, swishing 10 mL four times daily for about 2 minutes and then spitting it out without swallowing. They must avoid food or drink for at least 30 minutes after use. This mouthwash will be used throughout their standard care treatment with Dato-DXd. The study includes two groups one with breast cancer and one with lung cancer patients, enrolling about 100 participants total over 18 months. During the study, participants will be monitored for stomatitis incidence and severity up to 12 weeks after starting treatment, with additional assessments up to about 21 months for onset and resolution timing. Researchers will also track adherence to the mouthwash, any dose changes in Dato-DXd due to stomatitis, and overall safety. Follow-up for safety continues for 28 days after the last study dose, with various evaluations including clinical assessments throughout the treatment period.

Researchers are evaluating a new blood test technology called the genome-wide methylome enrichment platform to detect multiple types of cancer and distinguish between them. This observational case-control study includes people with various cancers such as brain, breast, lung, and others selected for their high prevalence and mortality. The study also aims to assess the platforms ability to detect minimal residual disease and early relapse specifically in lung cancer after treatment. Participants in the study are divided into two groups cases, who are newly diagnosed and have not yet received treatment for cancer, and controls, who have no known cancer. All participants will provide blood samples and clinical data at the start. Those with certain lung cancers will have additional blood draws and follow-ups every 3 to 6 months for up to 3 years after treatment. Controls will have follow-up visits every 6 months for up to 3 years to monitor cancer status. Throughout the study, blood samples from participants with and without cancer will be tested together using a sensitive, noninvasive DNA methylation profiling method that analyzes small amounts of cell-free DNA. Results from this liquid biopsy will not be shared with participants or their doctors. Researchers will track cancer detection over 24 months and monitor clinical outcomes for up to 54 months. Participants health status will be observed during follow-up visits to evaluate the tests performance in detecting cancer early and identifying relapse.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

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 whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

Researchers are conducting a Phase III, multisite, randomized, double-blinded trial to compare pumitamig BNT327 combined with chemotherapy etoposide and carboplatin against atezolizumab combined with the same chemotherapy in participants with previously untreated extensive-stage small-cell lung cancer ES-SCLC. The study aims to evaluate treatment safety and effectiveness, including overall survival and progression-free survival. The study includes two stages Stage 1 has two treatment arms with different doses of pumitamig and one control arm receiving atezolizumab, while Stage 2 has one treatment arm with a different pumitamig dose and a control arm. Treatment involves intravenous infusions of the study drugs and chemotherapy. Participants may switch from carboplatin to cisplatin if carboplatin is not tolerated. Each stage consists of a screening period, an induction and maintenance treatment period lasting up to 2 years or until disease progression or other endpoints, followed by a safety and survival follow-up phase. Participants undergo screening for eligibility before randomization. During the study, researchers monitor overall survival up to approximately 46 months, progression-free survival, response rates, adverse events, and quality of life through questionnaires. Safety follow-up visits occur after treatment ends. The total participation time may extend over several years, including treatment and follow-up assessments to evaluate long-term outcomes and safety.

Researchers are evaluating the combination of pumitamig also known as BNT327 or PM8002 with standard chemotherapy docetaxel in people with advanced or metastatic Non-small Cell Lung Cancer NSCLC that has progressed after first-line chemoimmunotherapy. This Phase II, multisite, open-label study aims to assess the safety and preliminary effectiveness of this combination treatment in this patient group. The study is designed in two parts to carefully monitor safety and expand dosing if appropriate. In Part 1, up to 12 participants will receive one of two dose levels of pumitamig combined with docetaxel in a safety run-in phase. Based on safety assessments, an internal review committee will decide whether to proceed to Part 2, where up to 54 additional participants will receive the recommended dose combination. In Part 2, some participants will also provide fresh tumor biopsy samples at baseline and during treatment for further analysis. Treatment continues until disease progression, unacceptable side effects, withdrawal, death, study end, or a 2-year limit. Participants will undergo regular assessments including safety monitoring for adverse events, dose adjustments, and tumor response using standard criteria. After treatment ends, a long-term follow-up will collect information on disease progression, new cancer treatments, and survival status. The primary outcomes focus on safety and response rates, while secondary outcomes include duration of response, progression-free survival, overall survival, and pharmacokinetics of pumitamig over approximately two years.

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.