Quincy

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

This trial evaluates nadofaragene firadenovec, a gene therapy using interferon alfa-2b amplification, compared with observation in participants with intermediate risk non-muscle invasive bladder cancer IR NMIBC. The study is a phase 3b, randomized, controlled trial aiming to assess treatment effects on recurrence-free survival over 24 months. Participants in the treatment group receive quarterly bladder instillations of nadofaragene firadenovec for 24 months. Disease evaluations occur within two weeks before each treatment instillation. Participants in both groups are followed according to the American Urological AssociationSociety of Urologic Oncology surveillance guidelines, which involve quarterly monitoring during the 24-month treatment period. During the study, participants undergo regular disease assessments, including monitoring for cancer recurrence and safety evaluations over 24 months. The main outcome measured is recurrence-free survival at 24 months. Adverse events and recurrence-free survival at 12 months are also tracked. Participants are monitored closely throughout the treatment and observation periods to evaluate long-term effects and safety.