Brewster

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 the therapeutic cancer vaccine OSE2101 in patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. This phase 3, multicenter, randomized, open-label study focuses on HLA-A2 positive patients with either squamous or non-squamous NSCLC. The study aims to compare the efficacy and safety of OSE2101 with the standard treatment docetaxel, considering factors like cancer histology and performance status. Participants will be randomized in a 21 ratio to receive either OSE2101 monotherapy or docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection of 5 mg peptides every three weeks for six cycles, then every eight weeks during the first year, and every twelve weeks until the end of the second year. Docetaxel is given as a 75 mgm2 intravenous infusion over one hour every three weeks. Additionally, a companion diagnostic device system is used to assess patient eligibility based on HLA-A2 phenotype. During the study, participants will have regular evaluations including clinical assessments and monitoring of survival time from randomization to death, which is the primary outcome measured over an average of three years. The study involves ongoing monitoring of treatment effects and safety. Participants can expect scheduled visits aligned with treatment cycles and assessments throughout the trial duration, which extends up to nearly five years from start to completion.