Gallatin

Researchers are evaluating the effectiveness and safety of Adagrasib (MRTX849) alone and combined with pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The study includes a Phase 2 portion focusing on patients with various PD-L1 scores and a Phase 3 portion comparing Adagrasib plus pembrolizumab versus pembrolizumab alone in patients with high PD-L1 levels. This research aims to improve first-line treatment options for advanced NSCLC. The Phase 2 study has three groups: two cohorts with low PD-L1 scores receiving either Adagrasib alone or combined with pembrolizumab, and one cohort with higher PD-L1 scores receiving the combination. In Phase 3, patients are randomly assigned to receive either Adagrasib with pembrolizumab or pembrolizumab alone. Adagrasib is taken orally twice daily, while pembrolizumab is given by intravenous infusion every three weeks. Participants will undergo regular assessments over 22 months for Phase 2 and 36 months for Phase 3, including evaluations of tumor response, safety, quality of life, and drug levels in the blood. Brain imaging is also used to check for metastases. Researchers will monitor progression-free survival, duration of response, and side effects to understand the treatments' impact and tolerability throughout the study period.

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. The study aims to assess the safety of PF-08634404 when given alone or in combination with other anticancer drugs and to observe how this cancer responds to these treatments. Participants must be adults with locally advanced or metastatic RCC who have not received prior treatment for their advanced kidney cancer. Participants will be randomly assigned to one of three groups: receiving PF-08634404 alone through intravenous (IV) infusion, PF-08634404 combined with ipilimumab, or PF-08634404 combined with axitinib. All treatments are administered by IV infusions at clinical study sites, where medical staff will monitor participants during and after each visit. The study includes phases 1b and 2 to evaluate safety and efficacy over time. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and adverse events, and evaluating survival and progression-free survival for up to approximately three years. Laboratory tests, pharmacokinetics, and immunogenicity will also be tracked. The study will continue monitoring participants for safety up to 90 days after the last treatment dose, with the total participation duration lasting about three years.

Researchers are evaluating the new medicine PF-08634404 combined with chemotherapy compared to the current standard treatment pembrolizumab with chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This phase 3, double-blind, randomized study focuses on adults 18 years or older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and who have not received prior treatment for advanced disease. Participants are divided into two parts based on tumor type: squamous NSCLC (Part 1) and non-squamous NSCLC (Part 2). Each participant is randomly assigned to receive either PF-08634404 or pembrolizumab along with a chemotherapy regimen specific to their tumor type. Treatments are given through intravenous infusions in cycles, with maintenance therapy continuing if the treatment is effective and side effects are manageable. Throughout the study, participants will attend regular visits for treatment administration and health monitoring. Cancer response will be assessed every 6 weeks during the first 48 weeks, then every 12 weeks thereafter. Researchers will measure overall survival, progression-free survival, response rates, quality of life, and safety through various assessments including imaging, laboratory tests, and questionnaires over approximately 32 to 39 months of follow-up.

Researchers are evaluating the combination of the investigational drug mevrometostat (PF-06821497) with enzalutamide compared to enzalutamide alone in men with metastatic castration-sensitive prostate cancer (mCSPC) who have not previously received androgen receptor pathway inhibitors or chemotherapy in this setting. This Phase 3, randomized, double-blind, placebo-controlled study aims to determine if the combination improves outcomes in participants who have only received limited prior therapy such as androgen-deprivation therapy or first-generation antiandrogens. Participants will be randomly assigned to one of two groups: one group will receive mevrometostat (875 mg twice daily) combined with enzalutamide (160 mg once daily), while the other group will receive a placebo twice daily plus enzalutamide (160 mg once daily). The study includes a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. The treatment phase may last up to approximately 4 years, with ongoing safety and long-term assessment extending beyond this period. During the study, participants will be monitored through various evaluations including scans, blood tests, and patient-reported questionnaires assessing pain and quality of life. Researchers will measure outcomes such as radiographic progression-free survival, overall survival, prostate-specific antigen response, and adverse events, among others. Follow-up will continue for several years to assess long-term effects and disease progression, ensuring comprehensive safety and efficacy data collection throughout the trial.

Researchers are conducting a multicenter, randomized, open-label phase 3 trial to evaluate treatments for patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors (ICI). The study focuses on patients positive for the HLA-A2 phenotype with either squamous or non-squamous histology. The trial compares the cancer vaccine OSE2101 to the standard chemotherapy drug docetaxel. Stratification factors include cancer histology and the patients' performance status. Participants will be randomly assigned in a 2:1 ratio to receive either OSE2101 or docetaxel. OSE2101 is a peptidic cancer vaccine given by subcutaneous injection every three weeks for six cycles, then every eight weeks through the first year, and every twelve weeks during the second year. Docetaxel is given as an intravenous infusion every three weeks. Additionally, a companion diagnostic device system is used to detect HLA-A2 status and analyze genetic markers. During the study, patient survival will be monitored from the time of randomization for an average of three years. Researchers will track overall survival as the primary outcome. Patients will undergo regular treatment visits, assessments, and monitoring according to the schedule. Safety, efficacy, and disease progression will be evaluated throughout the trial period, which starts in December 2024 and continues until December 2028.