Melanoma Clinical Trial
A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors
Summary
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine.
In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day.
In the second part of the study, people with melanoma with a certain type of abnormal gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07284890 or PF-07799933).
Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma
For Substudy A and B, measurable disease by RECIST version 1.1
For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood
For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood
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)
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There are 5 Locations for this study
Fayetteville Arkansas, 72703, United States
Fayetteville Arkansas, 72703, United States
Rogers Arkansas, 72758, United States
Rogers Arkansas, 72758, United States
Springdale Arkansas, 72762, United States
Springdale Arkansas, 72762, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
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