Hattiesburg

Researchers are evaluating new treatment options for people with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific gene mutation called KRAS G12C. This study aims to learn about the safety and tolerance of adding calderasib and cetuximab, two targeted therapies, to a chemotherapy regimen called mFOLFOX6. The study also compares how long participants live without their cancer growing or spreading when receiving the combination treatment versus standard chemotherapy with or without bevacizumab. The study has two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil given every two weeks. The other group will receive mFOLFOX6 chemotherapy every two weeks, with or without bevacizumab or a bevacizumab biosimilar, based on the investigator's choice. Treatment continues until certain criteria are met for stopping. Participants will be closely monitored through up to approximately 44 months or longer for side effects, treatment discontinuation, and how long their cancer remains stable without worsening. Researchers will also assess survival, quality of life using questionnaires, and response to treatment over several years. Safety and efficacy data will be collected throughout the study duration, which includes follow-up assessments up to 5 years.

Researchers are evaluating the safety and effectiveness of a combination treatment called KarXT and KarX-EC for adults aged 55 to 90 who have agitation linked to Alzheimer's Disease. This Phase 3 study aims to understand how this treatment may help manage agitation symptoms in this population, with careful monitoring of side effects and overall safety. Participants will receive either the KarXT plus KarX-EC treatment or a placebo, with doses given on specified days as capsules. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo. The treatment period lasts 14 weeks, during which participants are closely observed. During the study, participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) score to measure agitation changes at week 14. Additional evaluations include clinical global impressions, neuropsychiatric inventories, safety monitoring through lab tests, vital signs, body measurements, and assessment of side effects up to week 18. Caregivers will also report on participants' status, and safety will be closely followed throughout the trial.

Researchers are evaluating treatments for participants with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) in this Phase III, randomized, open-label, international study. The study aims to compare the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with durvalumab against investigator's choice chemotherapy combined with pembrolizumab, and also evaluates Dato-DXd alone. The main goal is to assess whether Dato-DXd with durvalumab helps participants live longer without their cancer worsening or improves overall survival compared to the standard chemotherapy plus pembrolizumab. Participants are assigned to one of three treatment groups: Dato-DXd combined with durvalumab; investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab; or Dato-DXd alone. All treatments are given by intravenous infusion. The study includes stratification by geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early stage TNBC. Throughout the study, participants will undergo regular assessments including imaging to measure cancer progression, laboratory tests, and evaluations of symptoms and quality of life. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and time to deterioration in symptoms such as pain and physical functioning. Safety and tolerability of the treatments will also be closely observed. Participation may last up to several years with ongoing follow-up to capture long-term outcomes.

Researchers are evaluating treatments for participants with KRAS/NRAS and BRAF wild-type colorectal cancer that is recurrent, unresectable, or metastatic. The study compares the length of time participants remain disease-free and overall survival when treated with amivantamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy. All participants have previously received chemotherapy, and the study is a randomized, open-label phase 3 trial sponsored by Janssen Research & Development, LLC. Participants are assigned to one of two groups. One group receives amivantamab combined with the FOLFIRI chemotherapy regimen, which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan. The other group receives either cetuximab or bevacizumab combined with FOLFIRI. Treatments are given in 28-day cycles and continue until the disease progresses or other reasons require stopping treatment. During the study, participants undergo regular assessments including imaging to monitor disease status and response to treatment. Researchers measure progression-free survival, overall survival, response rates, duration of response, and quality of life through questionnaires. Safety is monitored by tracking adverse events and laboratory test changes. The primary outcomes are evaluated up to about 2 years for progression-free survival and over 4 years for overall survival, with several secondary outcomes assessed up to the same longer timeframe.

This research aims to compare progression-free survival in adult participants with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. The study evaluates two first-line treatment approaches: amivantamab combined with chemotherapy versus cetuximab combined with chemotherapy. This is a Phase 3 randomized, open-label trial assessing outcomes for this specific cancer type. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles of either mFOLFOX6 (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin) or FOLFIRI (which includes 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan hydrochloride). The other group receives cetuximab combined with the same chemotherapy options. Each treatment cycle lasts 28 days, and participants continue treatment until disease progression or other stopping criteria are met. During the study, participants will undergo regular assessments including imaging scans reviewed by a blinded independent committee to measure progression-free survival up to 4 years and 2 months. Additional outcomes such as overall survival, response rates, duration of response, and quality of life will be monitored for up to over 7 years. Safety is tracked through adverse event reporting and laboratory tests. Participants' symptoms and functioning will also be evaluated using quality of life questionnaires throughout the study period.

Researchers are evaluating the anti-tumor activity of amivantamab alone and combined with standard chemotherapy in people with advanced or metastatic colorectal cancer. This study aims to find the recommended dose of amivantamab when added to chemotherapy and to assess its safety in these patients. Colorectal cancer is a common global cancer, and amivantamab targets specific receptors involved in tumor growth and resistance to treatment. Participants will receive amivantamab as an intravenous infusion either by itself or with chemotherapy regimens like mFOLFOX6 or FOLFIRI. Treatment cycles last 28 days, with doses adjusted based on body weight and prior therapies. The study includes multiple groups: those receiving amivantamab alone, and those receiving it combined with chemotherapy, with dosing schedules starting from Cycle 1 Day 1 or Day -2 depending on the group. During the study, participants undergo physical exams, performance status assessments, lab tests, vital sign monitoring, and adverse event tracking. Tumor response will be measured using criteria like RECIST over up to 4 years and 3 months. Participants may also have tumor biopsies and pregnancy tests as needed. The study continues until treatment discontinuation, with follow-up visits up to 30 days after stopping treatment to monitor safety and outcomes.

This research aims to compare the effectiveness of different drug combinations in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study evaluates zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R2) in FL, and zanubrutinib plus rituximab versus R2 in MZL. The main goal is to measure progression-free survival using imaging criteria assessed by an independent review committee following international lymphoma guidelines. Participants receive treatments according to their lymphoma type and assigned study arm. For FL, one group receives zanubrutinib with obinutuzumab followed by zanubrutinib alone until disease progression or other reasons stop treatment. The comparator group receives lenalidomide plus rituximab. For MZL, one group is treated with zanubrutinib plus rituximab followed by zanubrutinib alone, while the other receives lenalidomide plus rituximab. Zanubrutinib is taken orally daily in cycles, rituximab and obinutuzumab are given intravenously on specific days of 28-day cycles, and lenalidomide is taken orally for 12 cycles. Throughout the study, participants undergo regular imaging scans to measure disease response and progression. Researchers also assess other outcomes such as response duration, overall survival, quality of life, and adverse events over several years. Treatment continues until confirmed progression, unacceptable side effects, withdrawal, or study end. The study provides close monitoring and long-term follow-up to evaluate the treatments' impact on lymphoma control and patient well-being.

Researchers are evaluating telisotuzumab vedotin compared to docetaxel in adults with non-squamous non-small cell lung cancer (NSCLC) that has been previously treated. This study aims to determine if telisotuzumab vedotin works better and to assess its safety. Participants will have NSCLC with overexpression of the c-Met protein and will have previously received certain therapies. The trial is a phase 3, open-label, randomized study conducted globally with about 698 participants. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until criteria for stopping the study drug are met. After the main study, participants who benefit may continue treatment through an extension or rollover study. Treatments are given at hospitals or clinics worldwide. Participants will attend regular visits where doctors will monitor their health through medical assessments, blood tests, and questionnaires. Researchers will check how the disease is progressing and watch for side effects. The main outcomes measured include progression-free survival and overall survival over approximately 39 months. Secondary outcomes include tumor response and changes in quality of life and physical functioning. Safety and tolerability will be closely observed throughout the study.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM). This Phase 3 randomized study aims to understand which maintenance treatment may better delay disease progression in this patient group. Participants receive either iberdomide at one of three specified doses or lenalidomide, both given on specified days as maintenance treatment following ASCT. The study includes a two-stage design and is open-label, allowing researchers to monitor and compare outcomes across these treatment arms over time. During the study, participants will be regularly assessed for progression-free survival and other outcomes such as minimal residual disease negativity, overall survival, and quality of life using questionnaires. Monitoring will continue for up to 6 years for most outcomes, with some measures followed up to 12 years. Researchers will also track safety and adverse events throughout the study duration.

Researchers are investigating the efficacy and safety of golcadomide combined with rituximab compared to investigator's choice treatments in adults with relapsed or refractory follicular lymphoma who have received at least one prior systemic therapy. This multicenter, randomized, open-label Phase 3 study focuses on participants with confirmed follicular lymphoma that has returned or not responded to previous treatments, aiming to better understand treatment options in this setting. Participants will be randomly assigned to receive either golcadomide plus rituximab or one of the investigator's chosen regimens, which may include rituximab combined with lenalidomide, R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone), or rituximab with bendamustine. Each treatment involves specified doses on specified days, and the study compares these approaches over a treatment period. During the study, participants will be closely monitored through evaluations such as imaging scans, pathology reviews, and quality of life questionnaires. Researchers will assess progression-free survival up to approximately 32 months, along with other measures like overall response rate, overall survival, duration of response, and minimal residual disease status. Safety and treatment effects will be tracked, and participants may be followed for up to nearly seven years to gather comprehensive outcome data.