A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

Launched by PFIZER · Apr 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called PF-07799933 to see how safe it is and how well it works for people with advanced solid tumors that have a specific gene change known as a "BRAF alteration." The trial is looking for participants who have cancers like melanoma, non-small-cell lung cancer, thyroid cancer, or glioma, and whose current treatments are no longer working. To be eligible, participants need to have a confirmed diagnosis of an advanced tumor and specific types of BRAF changes in their tumor tissue or blood.

Participants will take PF-07799933 as a tablet twice a day, and some may also receive another medicine called binimetinib or cetuximab, depending on their cancer type. The treatment period may last around two years, and participants will have regular visits to the clinic to monitor their health and how they respond to the treatment. This trial is currently recruiting participants of all genders, aged 58 years and older, who meet the criteria. It’s a chance to try a new approach for managing their cancer when other options have failed.

Gender

ALL

Eligibility criteria

• This study is seeking participants who meet the following eligibility criteria:
• Inclusion Criteria:
• • Diagnosis of advanced/metastatic solid tumor including primary brain tumor.
• • Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA).
• • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2).
• • Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies
• Exclusion Criteria:
• • Brain metastasis larger than 4 cm
• • Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
• • For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)