Lages

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

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.

This trial focuses on people with platinum-sensitive recurrent ovarian cancer, including certain types of ovarian, primary peritoneal, or fallopian tube cancers. It aims to study the safety and tolerance of sacituzumab tirumotecan combined with bevacizumab and compare how long participants live without their cancer worsening when treated with sacituzumab tirumotecan, with or without bevacizumab, versus standard care. The study is a Phase 3, randomized, open-label trial designed to evaluate these treatments after second-line platinum-based chemotherapy. Participants are assigned to one of three groups one group receives sacituzumab tirumotecan plus bevacizumab through intravenous infusions every 2 and 3 weeks respectively for 6 weeks another group receives sacituzumab tirumotecan alone every 2 weeks for up to about 2 years or until the disease progresses, with optional bevacizumab at the doctors choice the third group follows the local standard care until progression, with optional bevacizumab as determined by the physician. The study includes rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, and steroid mouthwash taken as needed according to approved guidelines. During the study, participants will be monitored for adverse events up to 6 weeks in Part 1 and for progression-free survival for up to about 4 years in Part 2. Additional assessments include overall survival for up to 6 years and quality of life measures through questionnaires at baseline and periodically up to approximately 4 years. Safety and treatment tolerability will be closely tracked, and participants will have intravenous infusions and follow-up visits throughout the study period, which may last several years depending on disease progression and treatment continuation.

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating the safety and effects of PF-07799544 alone or combined with PF-07799933 as a potential treatment for adults with advanced solid tumors that have a BRAF V600 mutation. This phase 1ab open-label study is focused on patients with metastatic or recurrent solid tumors, excluding colorectal cancer. The trial includes two parts phase 1a studying PF-07799544 alone and phase 1b studying the combination of both drugs. Phase 1a enrollment is closed, while phase 1b is actively seeking participants. In this study, all participants receive both PF-07799544 and PF-07799933 as oral tablets taken at home twice daily. Treatment continues until cancer progression, unacceptable side effects, or a maximum of two years, with the option to extend therapy beyond two years. The study aims to understand patient experiences with these medicines and to determine their safety and effects. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, lab abnormalities, vital signs, and physical exams from baseline through the treatment period and up to 28 days after the last dose. The primary outcome evaluates overall response rate during the two-year treatment. Additional pharmacokinetic data and long-term safety are also collected. The total participation duration may extend up to two years or longer if treatment continues.

Researchers are evaluating linvoseltamab, an experimental drug also called REGN5458, in adults with multiple myeloma that has returned or needs treatment again after one to four prior therapies. The study compares linvoseltamab to a combination of three cancer drugs elotuzumab, pomalidomide, and dexamethasone EPd. This phase 3 study aims to assess the safety and effectiveness of linvoseltamab versus EPd in participants who have standard treatment options available and have previously received certain therapies including lenalidomide and a proteasome inhibitor. Participants are randomly assigned to one of two groups one receiving linvoseltamab by intravenous infusion, and the other receiving the EPd combination, with elotuzumab given by infusion and pomalidomide and dexamethasone given by mouth or infusion. The study focuses on how long participants benefit from the treatments, the degree of tumor response, side effects, survival, and pain improvement. During the study, participants will undergo regular assessments including disease response evaluations based on established criteria, safety monitoring, and patient-reported outcomes like pain and quality of life questionnaires. The primary measure is progression-free survival over up to about five years. Researchers will also track overall survival, adverse events, antibody responses, and other health status measures. Participation involves treatment, follow-up visits, and ongoing monitoring to understand the treatments impact.

Researchers are studying an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. The trial is a Phase 3, open-label, randomized study comparing odronextamab to rituximab combined with different chemotherapy regimens, which represent the current standard treatment. The study aims to evaluate the safety, tolerability, and how well odronextamab works compared to standard care, including side effects, drug levels in the blood, antibody development against the drug, and quality of life impacts. The study has two parts Part 1 is a non-randomized safety run-in where all participants receive odronextamab alone to assess safety and tolerability. In Part 2, participants are randomly assigned to one of two groups one receiving odronextamab followed by maintenance therapy with odronextamab, and the other receiving rituximab combined with chemotherapy followed by rituximab maintenance. Chemotherapy regimens include CHOP, CVP, or bendamustine, administered as per protocol. Participants will be monitored regularly for treatment side effects, drug concentrations, and immune responses for up to 5 years. Researchers will assess responses using imaging and other tests at multiple time points, including complete response at 30 months and progression-free survival up to 5 years. Quality of life and physical function will also be evaluated using standardized questionnaires. Safety and adverse events will be tracked for up to 2 years, ensuring comprehensive follow-up throughout the study duration.