Leeuwarden

Researchers are investigating new treatments for people with high-risk, localized non-small cell lung cancer NSCLC that has been completely removed by surgery. The study aims to find out if giving one or two specific treatments after surgery can help prevent the cancer from returning. This Phase 3 trial focuses on participants with Stage I NSCLC who have certain high-risk features. Participants are randomly assigned to one of three groups one group receives intismeran combined with pembrolizumab coformulated with berahyaluronidase alfa, another group receives intismeran alone, and a third group receives a placebo. Intismeran is given as an intramuscular injection, while pembrolizumab with berahyaluronidase alfa is administered subcutaneously. The trial compares disease-free survival among these groups over an extended period. Throughout the study, participants will be monitored regularly with health assessments and questionnaires to evaluate quality of life and physical functioning. Researchers will track how long participants remain free from cancer and observe any side effects or adverse events. The study may last up to several years, with ongoing safety and outcome evaluations to better understand the treatments impact.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are investigating whether adding intismeran autogene to pembrolizumab after surgery helps people with non-small cell lung cancer NSCLC stay cancer-free longer compared to pembrolizumab with a placebo. This study focuses on participants whose tumors did not fully respond to treatment before surgery. It is a phase 3 trial aiming to evaluate treatment options for resectable stage II to IIIB N2 NSCLC patients who did not achieve a complete pathological response after neoadjuvant therapy. Participants receive neoadjuvant treatment with pembrolizumab and chemotherapy drugs such as cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel, given by intravenous infusion every three weeks for up to four cycles. After surgery, participants receive adjuvant treatment with pembrolizumab every six weeks combined with either intismeran autogene or placebo by intramuscular injection every three weeks, for up to seven and nine doses respectively. During the study, participants undergo treatment cycles, surgery, and follow-up assessments. Researchers evaluate disease-free survival over approximately 97 months and monitor overall survival, metastasis-free survival, quality of life, physical and role functioning, and adverse events up to around 129 months. The study includes regular evaluations and safety monitoring to understand the impact of these treatments on long-term outcomes and participant well-being.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Researchers are evaluating the effects of CIT-013 on adults with moderately active rheumatoid arthritis RA. The study aims to find out if CIT-013 can reduce disease activity and to monitor any medical problems that may occur during treatment. This Phase IIa trial compares CIT-013 at three different dose levels to a placebo to determine its impact on RA symptoms. Participants will receive subcutaneous injections of CIT-013 or placebo every other week over 12 weeks. The treatment involves multiple arms, including low, medium, and high doses of CIT-013, as well as a placebo group. Each participant receives 3 to 6 injections according to their assigned dose group. The study includes a randomized, double-blind design to fairly compare the effects of the different doses and placebo. During the trial, participants will visit the clinic every two weeks for checkups and tests. Researchers will monitor disease activity using the DAS28-CRP score at week 6 compared to baseline. Safety is assessed by tracking treatment-emergent adverse events over 12 weeks and measuring CIT-013 levels in the blood at various time points. Participants will keep track of their symptoms throughout the study, which lasts about three months.

Researchers are studying a treatment approach for older adults with acute myeloid leukemia AML who are not suitable for intensive chemotherapy. The study focuses on combining the drug venetoclax with azacitidine, and investigates whether adding cobicistat, a drug that increases venetoclax exposure, can allow for lower venetoclax doses to reduce treatment costs. This is a Phase II trial led by Stichting Hemato-Oncologie voor Volwassenen Nederland, addressing the challenge of treating older, unfit AML patients with fewer side effects and financial burden. Participants receive azacitidine and venetoclax from the first treatment cycle until relapse. Cobicistat is introduced during the run-in phase starting from cycle 2 and during the extension phase starting from cycle 1, aiming to boost venetoclax levels. The study includes a run-in phase with 20 patients and an extension phase, both following this treatment scheme. The trial is single-arm and non-randomized, designed to evaluate pharmacokinetic equivalence and overall survival among other outcomes. Throughout the study, participants will undergo regular monitoring to assess drug levels, treatment response, safety, and side effects for up to 48 months. Researchers will measure remission rates, survival rates, genetic changes, adverse events, and medication adherence. Data on cost savings and treatment effects will also be collected. Patients will be assessed for kidney and liver function, and their progress will be carefully followed to understand the impact of the cobicistat-boosted venetoclax treatment combined with azacitidine.

Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer AFT with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.

Researchers are studying the effects of combining two chemotherapy drugs with immunostimulants in patients with previously untreated metastatic or locally advanced esophagogastric cancer. This study focuses on how these treatments affect interferon gamma expression and the presence of cytotoxic T cells in the tumor environment. It is a phase 2, open-label study enrolling 25 patients with this specific cancer type who have not received prior chemotherapy or radiotherapy for their metastatic or irresectable disease. Participants receive two cycles of chemotherapy with capecitabine and oxaliplatin, each cycle lasting three weeks. After chemotherapy, they receive retifanlimab immunotherapy every four weeks for up to two years. The chemotherapy is given by mouth and intravenously, while retifanlimab is administered intravenously. The study includes collection of biopsies, blood, and feces samples during treatment to analyze immune cell infiltration and interferon gamma expression. During the study, patients undergo CT scans before and after chemotherapy and after 2-3 cycles of immunotherapy to evaluate tumor response. Researchers monitor immune activity in the tumor, overall survival, progression-free survival, response rates, adverse events, and patient-reported outcomes over periods up to 60 months. Safety and treatment effects are carefully assessed throughout the study, with treatment lasting up to two years and follow-up continuing for several years.