Santa Rosa

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are conducting a prospective, longitudinal, non-interventional, multicenter study to profile molecular biomarkers in patients with head and neck squamous cell carcinoma (HNSCC). The study focuses on individuals with metastatic or unresectable, recurrent HNSCC who are receiving standard of care treatment. The aim is to explore DNA, RNA, immune, and other multiomic biomarkers to better understand prognostic or predictive indicators that could inform future research on relevant biomarkers. Participants will provide tissue and blood samples for molecular biomarker profiling throughout their standard treatment, which involves first line anti-PD1 or PDL1 monotherapy or combination therapy. Tumor tissue samples representative of the current disease must be submitted according to laboratory guidelines. This observational study does not involve any investigational treatments or interventions beyond the participants' usual care. During the study, participants will undergo molecular analyses of their tissue and blood samples over a period of up to 5 years. Researchers will monitor multiomic biomarkers to identify prognostic or predictive factors. The study includes follow-up to collect data that may support the discovery of new biomarkers. Participants must be willing and able to comply with study procedures, including additional blood sample collections.

Researchers are evaluating a new compound called AZD8205 as a potential treatment for advanced or metastatic solid tumors, either alone or combined with other anti-cancer drugs. This Phase I/IIa multi-center, open-label study focuses on patients with advanced solid tumors including breast cancer, biliary tract cancer, ovarian cancer, endometrial cancer, and squamous non-small cell lung cancer. The study aims to understand the safety and effects of AZD8205 and its combinations in these patient populations. Participants may receive AZD8205 alone or combined with other agents such as rilvegostomig, a bispecific antibody targeting TIGIT and PD-1; saruparib, a PARP inhibitor; or AZD9574, another PARP inhibitor. Various combinations include AZD8205 with rilvegostomig, saruparib, both saruparib and rilvegostomig, or AZD9574 with or without rilvegostomig. The study uses dose escalation and expansion phases to assess these treatments. Treatment is given according to the assigned group, with dosing schedules and combinations tailored to evaluate safety and tolerability. During the study, participants will be closely monitored for safety including adverse events, serious adverse events, and dose-limiting toxicities. Laboratory tests, ECGs, and vital signs will be regularly checked from the time of informed consent through 30 days after the last dose, covering about one year in total. Researchers will also assess measurable disease response and overall health status. This comprehensive evaluation helps determine the potential of AZD8205 and its combinations as treatments for advanced solid tumors.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating the safety and effectiveness of various new drug combinations, including novel agents combined with standard treatments, for people with advanced or metastatic non-small cell lung cancer (NSCLC). This open-label, multicenter trial focuses on sub-study 2, which examines rilvegostomig combined with standard platinum-based chemotherapy, with or without ramucirumab, in participants with advanced NSCLC. The study aims to identify optimal doses and expand cohorts to better understand treatment safety and tumor response. The trial involves two parts: Part A includes safety run-in groups to test different dose levels of rilvegostomig and establish the recommended Phase 2 dose if not already known. Part B expands to larger groups to assess treatment effects. Rilvegostomig and other study drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, nab-paclitaxel, and ramucirumab are given by intravenous infusion according to the study protocol. Sub-study 1 was canceled and will not take place. Participants will undergo assessments including tumor tissue sampling, disease measurement scans, and laboratory tests to monitor organ function and treatment effects. Researchers will track adverse events, serious adverse events, dose-limiting toxicities, and tumor responses over approximately 46 months. Safety, tolerability, and anti-tumor activity are key outcomes, with follow-up to ensure participant well-being and gather comprehensive data on these novel treatment combinations.

Researchers are evaluating PRL-02 depot, a potential injectable treatment for men with advanced prostate cancer whose cancer has returned after previous treatments or did not respond well. This phase 1 study aims to assess the safety, tolerability, and appropriate dosing of PRL-02 depot when given alone or with another medicine called enzalutamide. The study includes men with different types of metastatic prostate cancer, including castration-resistant and castration-sensitive forms, some of whom have previously taken specific hormone therapies. The study is conducted in two parts. In the first part, small groups of men receive increasing doses of PRL-02 depot along with other medicines like dexamethasone, prednisone, or enzalutamide depending on the group. In the second part, men who have taken hormone therapy abiraterone acetate or one other hormone therapy participate. All men receive PRL-02 depot injections into a muscle every 12 weeks and take daily oral medications as per their group assignment. Participants will visit the clinic regularly for health checks, scans, and laboratory tests to monitor safety and effectiveness. Researchers will track side effects, laboratory and heart monitoring results, performance status, and testosterone levels over up to four years. Men whose cancer does not worsen after the study will continue with periodic health assessments and scans. The total participation time varies based on individual response and study progression.

Researchers are comparing how long participants with KRAS/NRAS and BRAF wild-type recurrent, unresectable, or metastatic colorectal cancer remain disease-free and their overall survival time when treated with two different regimens. This phase 3 study focuses on patients who have previously received chemotherapy. The study aims to evaluate progression-free survival and overall survival in participants receiving amivantamab plus FOLFIRI versus cetuximab or bevacizumab plus FOLFIRI. The study involves two treatment groups: one receiving amivantamab combined with chemotherapy drugs 5-fluorouracil, leucovorin calcium or levoleucovorin, and irinotecan (FOLFIRI), and the other receiving either cetuximab or bevacizumab with the same chemotherapy regimen. Participants will be randomly assigned to one of these treatment arms. The treatments will be administered according to protocol to assess their effects on the cancer. Participants will be monitored for up to 2 years and 1 month to measure progression-free survival through blinded independent central review and followed for overall survival for up to 4 years and 4 months. The study includes assessments of tumor response, safety, and other clinical evaluations. Tissue samples and detailed clinical data will also be collected. This comprehensive monitoring will help determine the comparative effectiveness of the treatment options over time.

This trial is focused on adults with KRAS/NRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer. It compares the length of time participants remain free from disease progression when treated with amivantamab combined with chemotherapy regimens (mFOLFOX6 or FOLFIRI) versus cetuximab combined with the same chemotherapy regimens. The study is a randomized, open-label Phase 3 clinical trial designed to evaluate progression-free survival over a period of up to 4 years and 2 months. Participants receive either amivantamab with chemotherapy drugs including 5-fluorouracil, leucovorin calcium or levoleucovorin, oxaliplatin, or irinotecan hydrochloride, or cetuximab with the same chemotherapy regimens (mFOLFOX6 or FOLFIRI). Treatments are administered as first-line therapy for their colorectal cancer. The trial assesses how these treatments affect disease progression and survival. During the study, participants will be monitored regularly through assessments and evaluations to measure progression-free survival. Researchers will gather data via blinded independent central review to ensure unbiased assessment of disease status. Participants are followed up for safety and treatment efficacy over the study duration, which may last over four years.