La Laguna

Researchers are conducting a master protocol study called CAMPFIRE to efficiently carry out multiple clinical trials testing new drugs in children and young adults with cancer. This master protocol allows for adding new studies as new cancer drugs become available, focusing on the treatment of measurable or evaluable tumors in participants aged 1 to 39 years. The goal is to evaluate various drugs under a unified research plan to improve treatment options for young cancer patients. The study involves several investigational drugs administered either intravenously or orally, including Ramucirumab, Cyclophosphamide, Vinorelbine, Gemcitabine, Docetaxel, Abemaciclib, Irinotecan, and Temozolomide. Each drug is tested under specific clinical trials within the master protocol, with treatment schedules and dosing tailored to each drug. Participants receive these treatments following standard clinical procedures, with adjustments based on individual study protocols and treatment responses. Participants will be closely monitored throughout the trial, with assessments including performance status evaluations, laboratory tests to check organ and blood function, and pregnancy testing for females of childbearing potential. Researchers will track how many participants receive each treatment during the first four weeks and observe the duration of treatment benefits. Safety evaluations, adherence to contraceptive measures, and recovery from prior therapies are also part of the study monitoring. Participation duration and additional assessments depend on the specific trial and treatment plan assigned.

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating the effectiveness and safety of zanidatamab combined with a physician's choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer. This study focuses on participants whose cancer has progressed or who cannot tolerate previous treatment with trastuzumab deruxtecan (T-DXd). The study is a phase 3 randomized trial aiming to assess progression-free survival and other important outcomes such as patient-reported tolerability and physical functioning. Participants receive either zanidatamab or trastuzumab through intravenous infusion, alongside chemotherapy drugs chosen by their physician from eribulin, gemcitabine, vinorelbine (all intravenous), or oral capecitabine. The study includes detailed monitoring of drug safety and how the body processes zanidatamab. The treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including scans to measure cancer progression according to RECIST guidelines. Researchers also monitor safety through laboratory tests and heart function assessments. Participants are followed for up to approximately 44 months to measure progression-free survival and overall treatment outcomes. Long-term follow-up and patient-reported outcomes help provide a complete understanding of the treatments' effects.

This research aims to provide ongoing access to treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen studies that include daratumumab. It allows all participants from daratumumab studies and those in daratumumab-containing arms of related studies, which have reached clinical cutoff for final analysis, to continue treatment. The study also collects long-term safety data from these participants. The treatments being evaluated include daratumumab, which is given either intravenously or subcutaneously, carfilzomib administered intravenously, dexamethasone given orally or intravenously, and oral medications lenalidomide and pomalidomide. Participants will continue to receive these treatments as part of this long-term extension study following their previous study treatment. During the study, participants will be monitored for safety, including tracking serious adverse events, adverse events of special interest, pregnancies, and abnormal pregnancies over a period of 3 years and 7 months. Assessments include pregnancy testing for women of childbearing potential and adherence to lifestyle restrictions. Participants must provide informed consent and will be followed closely to evaluate the long-term effects and safety of their treatment.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior therapy. This Phase 3 study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate and if it is better regarding progression-free survival, both assessed using standardized disease criteria by independent review. Participants will be randomly assigned to receive one of the three oral treatments: nemtabrutinib, ibrutinib, or acalabrutinib. The study compares the effectiveness of nemtabrutinib against the other two drugs chosen by the investigator to treat first-line CLL/SLL. Treatment continues with monitoring over months to assess response and disease progression. During the study, participants will undergo evaluations based on the International Workshop on Chronic Lymphocytic Leukemia criteria, including blinded independent central reviews of their disease status. Researchers will track objective response rates up to about 33 months and progression-free survival up to around 104 months. Participants will also be monitored for safety and treatment adherence throughout the trial period.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

Researchers are investigating the effects of teplizumab compared with a placebo in children and young adults aged 1 to 25 years who have recently been diagnosed with Stage 3 type 1 diabetes (T1D). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess changes in blood sugar control and dependence on prandial insulin over one year. The study follows established criteria for Stage 3 T1D diagnosis and includes participants on standard insulin therapy. Participants will receive either teplizumab or placebo through intravenous infusion. Both treatments are given as a solution for injection. The study spans approximately 84 weeks (18 months) for each participant, with the main treatment period lasting 52 weeks. The trial compares the effects of the two treatments on diabetes management and insulin use over this time. During the study, participants will undergo evaluations of their blood sugar control, including measurements of glycated hemoglobin (HbA1c) and insulin use. For those in European Union countries aged 5 years and older, additional tests will measure insulin production response after a meal. Safety and health will be monitored through regular clinical assessments, lab tests, and antibody screening. The study tracks changes from the beginning through the 52-week treatment period to understand the impact of teplizumab on diabetes progression.

Researchers are evaluating how the study medicine PF-06823859 (dazukibart) works in adults with active idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM). These rare diseases cause muscle inflammation that weakens muscles important for movement, and DM may also cause a characteristic skin rash. The study aims to understand the safety and effectiveness of dazukibart compared to placebo in this patient group. Participants will receive either the study medicine or a placebo, both given as intravenous (IV) infusions lasting about 1 hour. These infusions will be administered every 4 weeks from the first day up to Week 48 at the study site. The study includes a total duration of about 13 months with 15 visits to the study site for treatment and monitoring. During the study, participants will be monitored through regular visits where researchers will assess their health and response to treatment. The main outcome measured is the moderate change in the Total Improvement Score (TIS) at 24 weeks for sites outside the United States and at 52 weeks for sites within the United States. Safety and other health evaluations will be conducted throughout the study to understand how participants respond to the study medicine compared to placebo.