Wytheville

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 the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

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 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 evaluating the safety and effectiveness of lutetium (177Lu) vipivotide tetraxetan (AAA617) in adult men with oligometastatic prostate cancer (OMPC) that is progressing after initial treatment to the primary tumor. This Phase III study aims to determine if AAA617 can control recurrent tumors and delay the need for androgen deprivation therapy (ADT), while preserving quality of life. The study focuses on early-stage prostate cancer patients with limited metastatic lesions that are positive for prostate-specific membrane antigen (PSMA). All participants will undergo a baseline PET/CT scan using either gallium (68Ga) gozetotide or piflufolastat (18F) to confirm PSMA-positive lesions, along with conventional imaging such as CT/MRI and bone scans. Following randomization, all metastatic lesions will receive stereotactic body radiation therapy (SBRT) over approximately 3 weeks. Participants randomized to the investigational arm will then receive up to 4 cycles of AAA617 treatment, given once every 6 weeks. Those in the observation group will end treatment after SBRT. Visits are scheduled weekly during treatment cycles and every 16 weeks afterward until disease progression, with the overall study lasting about 6.5 years. During the study, participants will have regular assessments including imaging scans, laboratory tests, and clinical evaluations to monitor disease progression and side effects. A blinded independent review committee will measure metastasis-free survival, tracking time from randomization until evidence of distant metastasis or death, for up to 30 months. Safety and quality of life will also be closely monitored throughout the study and follow-up periods.

Researchers are evaluating the effectiveness and safety of sacituzumab govitecan-hziy (SG) combined with pembrolizumab compared to the treatment chosen by a doctor, which may be pembrolizumab alone or pembrolizumab with capecitabine. This study focuses on patients with triple negative breast cancer who still have invasive cancer remaining after surgery and pre-surgical treatment. The study is a phase 3, randomized, open-label trial designed to assess outcomes in this patient group. Participants receive sacituzumab govitecan-hziy and pembrolizumab through intravenous infusion as the experimental treatment. The comparison group receives the physician's choice of treatment, which involves either pembrolizumab alone intravenously or pembrolizumab combined with oral capecitabine tablets. Both treatment options follow surgery and prior therapy, targeting residual invasive disease. Throughout the study, participants are monitored up to 60 months to measure invasive disease-free survival, which indicates the time without cancer recurrence or progression. Researchers will track treatment safety and effectiveness through regular assessments. The study involves tissue sample submissions from before and after neoadjuvant therapy and surgery, performance status evaluations, organ function tests, and recovery status from surgery and radiotherapy.

Researchers are evaluating the safety and effectiveness of [177Lu]Lu-DOTA-TATE combined with octreotide long-acting release (LAR) compared to octreotide LAR alone. The study focuses on newly diagnosed patients aged 12 and older who have somatostatin receptor positive (SSTR+), well-differentiated Grade 1 or Grade 2 (Ki-67 <10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with a high disease burden. This Phase III study aims to better understand treatment outcomes for this patient population.

Researchers are evaluating a new medicine called PF-08634404 to see how well it works in adults with colorectal cancer that has spread or returned after previous treatments. This study focuses on whether PF-08634404 combined with approved chemotherapy can help patients compared to another approved medicine called Bevacizumab combined with chemotherapy. The study is a Phase 3, double-blind, randomized trial involving participants who have metastatic colorectal cancer and have not received prior systemic therapy for metastatic disease. Participants will be randomly assigned to one of two groups: one receiving PF-08634404 plus chemotherapy, and the other receiving Bevacizumab plus chemotherapy. Both treatments are given by intravenous infusion in cycles. Participants may continue treatment if it is beneficial and side effects are manageable. Treatments are administered at clinical sites with medical staff monitoring participants during and after each infusion. During the approximately 33-month study, participants will visit the study site regularly for treatment, health checks, and tests. After stopping treatment, there will be a follow-up visit about 30 to 37 days later to assess health and side effects. Participants will also have follow-up every 12 weeks by phone, in person, or through health record reviews to monitor their health status and any new treatments. The main outcomes measured include progression-free survival and overall survival over about 4 years.

Researchers are studying a new medicine called PF-08634404 to learn more about its safety, how it works, and how it affects adults with locally advanced or metastatic urothelial cancer, a type of bladder cancer that has spread to nearby tissues or other parts of the body. The study also examines how the medicine may change certain markers linked to cancer. This research is an interventional Phase 1B/2 trial including participants who have this specific cancer type. The study includes two groups: Cohort A consists of people who have already received treatment for their cancer and will receive PF-08634404 alone. Cohort B includes participants who have not been treated before and will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin. Both treatments are given through a vein (IV infusion). Treatment continues as long as it is helpful and side effects are manageable. Participants will first go through a screening period to confirm eligibility. During the study, they will have regular visits for treatment, health checks, and tests to monitor how the cancer responds, including regular scans. Researchers will measure how well the treatment works by confirmed objective response rate and will monitor safety by tracking adverse events, serious adverse events, and dose-limiting toxicities for up to about three years. If the cancer worsens but treatment still helps and side effects remain manageable, participants may continue treatment with approval from their doctor and the study sponsor.

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma (RCC), a type of kidney cancer that has spread locally or to other parts of the body. This phase 1b/2 study aims to assess the safety and how well PF-08634404 works alone or combined with other anticancer medicines in treating this advanced kidney cancer. Participants must be adults who have not yet received treatment for their advanced RCC. Participants will receive PF-08634404 either by itself or together with other anticancer drugs through intravenous (IV) infusions administered at clinical study sites by trained medical staff. The study includes treatment periods where the medicine is given as a concentrate solution for infusion, with combinations involving two other anticancer drugs also evaluated. All treatments occur under close medical supervision at the study centers. During the study, participants will have regular assessments including measuring tumor response using RECIST v1.1 criteria for up to approximately three years. Researchers will monitor safety by tracking treatment-emergent and serious adverse events, as well as dose-limiting toxicities during the evaluation period. Participants' health will be closely followed through clinical and laboratory tests throughout the study to understand the medicine's effects and safety profile.