Lages

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with locally advanced, unresectable, or metastatic stomach or gastroesophageal junction (GEJ) cancer. This study focuses on cancer cells that are HER2-negative but positive for the Claudin 18.2 protein and PD-L1, exploring how well zolbetuximab helps the immune system attack the tumor alongside immunotherapy and chemotherapy. The trial is a phase 3, randomized, double-blind study designed to compare the overall survival of participants receiving zolbetuximab with pembrolizumab and chemotherapy versus those receiving a placebo with pembrolizumab and chemotherapy. Participants receive study treatment in 6-week cycles, with zolbetuximab or placebo given by infusion every 2 or 3 weeks. Chemotherapy regimens include either CAPOX (capecitabine tablets and oxaliplatin infusion) or mFOLFOX6 (infusions of 5-fluorouracil, folinic acid, and oxaliplatin) administered on schedules matching the cycles. Pembrolizumab is infused every 3 or 6 weeks. Treatment continues until cancer worsens, is not tolerated, or another therapy is needed, with pembrolizumab given for up to 2 years. After initial cycles, some chemotherapy drugs are adjusted to only include oral capecitabine or certain infusions. During the study, participants visit the clinic for treatments, health checks, and scans to monitor cancer changes and side effects. Researchers also track medical problems related to the treatments and may collect tumor samples if cancer worsens. After stopping treatment, participants have follow-up visits and scans every 9 to 12 weeks, along with telephone check-ins every 3 months. The primary outcome measured is overall survival up to 72 months, with ongoing monitoring to evaluate safety and treatment effects.

Researchers are evaluating the safety and effectiveness of sacituzumab tirumotecan with or without bevacizumab compared to standard care in women with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. This phase 3 study aims to learn how well patients tolerate these treatments and whether they live longer without their cancer worsening. The study focuses on those who have already undergone second-line platinum-based chemotherapy and have specific cancer stages and types. Participants receive sacituzumab tirumotecan and may also receive bevacizumab through intravenous infusion. Before sacituzumab tirumotecan, rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, and steroid mouthwash are given to help manage side effects. The study includes multiple treatment phases and compares these interventions to standard care. These treatments are administered under close medical supervision throughout the study. During the study, participants are monitored for adverse events and treatment tolerability over approximately six weeks in the first part, followed by progression-free survival tracking for up to about four years. Assessments include physical exams, performance status evaluations, and safety monitoring. Researchers also collect tumor tissue samples and conduct laboratory tests to evaluate treatment effects. The total participation time involves ongoing observation to measure safety and effectiveness outcomes.

Researchers are evaluating the safety and effects of the medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This type of breast cancer involves cancer cells that grow in response to hormones like estrogen and progesterone but have little or no HER2 protein. The study focuses on people whose breast cancer worsened after treatment with cyclin dependent kinase (CDK) 4/6 inhibitor therapy. The trial is a phase 3, open-label, randomized study comparing PF-07248144 plus fulvestrant to other therapies chosen by doctors. Participants will receive either PF-07248144 tablets daily at home in 28-day cycles combined with fulvestrant injections at the clinic, or the usual treatment of everolimus tablets with endocrine therapy (either exemestane or fulvestrant). The study doctor will help decide the hormone therapy before starting treatment. The trial compares the experiences of those taking PF-07248144 plus fulvestrant with those receiving standard treatments to assess safety and effectiveness. During the study, researchers will monitor participants for disease progression or death, using blinded independent central review based on standard tumor response criteria. The main outcome measure is progression-free survival for up to about 2 years from randomization. Regular assessments, including clinical visits for injections and evaluations, will help track treatment effects and safety throughout the study.

Researchers are evaluating the safety and effects of the study medicine PF-07799544, alone or combined with PF-07799933, as a potential cancer treatment for adults with advanced solid tumors. This trial involves participants with metastatic or recurrent solid tumors (excluding colorectal cancer) that have a BRAF V600 mutation and who have received prior cancer treatments as assigned. Phase 1a of the study, which involved PF-07799544 alone, is closed for enrollment, and the current Phase 1b focuses on combination therapy with both medicines. All participants in Phase 1b will take both study medicines as tablets by mouth twice daily at home. Treatment will continue until the cancer no longer responds, unacceptable side effects occur, or for up to two years. Participants may continue therapy beyond two years if appropriate. The study is designed to monitor the safety and potential effectiveness of these treatments in this patient population. Participants will be assessed for dose limiting toxicities, treatment-emergent adverse events, and clinically significant changes in laboratory tests, vital signs, and physical exams during the first 21 days and up to 28 days after the last dose. The overall response rate will be measured for up to two years. Safety and treatment effects will be carefully monitored throughout, with the goal of understanding how these medicines impact patients with BRAF-mutant advanced solid tumors.

Researchers are evaluating an experimental drug called linvoseltamab (REGN5458) for adults with relapsed or refractory multiple myeloma who have had one to four previous treatments and have standard treatment options available. This phase 3 study compares linvoseltamab to a combination of three cancer drugs: elotuzumab, pomalidomide, and dexamethasone (EPd). The study aims to assess the safety and effectiveness of linvoseltamab compared to EPd, including how long participants benefit, tumor response, side effects, survival, and pain improvement. Linvoseltamab is given by intravenous infusion, while the comparison group receives elotuzumab by infusion and pomalidomide capsules and dexamethasone tablets or capsules by mouth or IV. Participants are randomly assigned to receive either linvoseltamab or the EPd combination. The study includes participants who have previously received lenalidomide, a proteasome inhibitor, and in some cases, a CD38 antibody. Treatment continues as per protocol with ongoing monitoring. Participants will undergo regular assessments to evaluate their disease response and side effects. Researchers will monitor progression-free survival for up to approximately five years. Assessments include measuring tumor response, survival, pain levels, and safety. Participants must have measurable disease and adequate organ function, and they will be followed closely to assess how well the treatments work and their safety over time.

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are evaluating the effectiveness of perioperative dostarlimab compared to the standard of care in adults with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability. This is a Phase 3, open-label, randomized study aiming to improve treatment outcomes for this specific type of colon cancer. Participants will receive either dostarlimab alone or standard chemotherapy regimens such as CAPEOX or FOLFOX. The treatments are given around the time of surgery (perioperative) to address the cancer before and after surgical removal. The study compares the new treatment approach with the current standard therapies to see which is more effective and safe. During the study, participants will be monitored for up to approximately 5 years to assess event-free survival, meaning the length of time they remain free from cancer recurrence or other related events. Researchers will perform regular evaluations, including imaging and clinical assessments, to track the participant’s progress and treatment response. Safety and side effects will also be closely observed throughout the study duration.