A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
Recruiting · NCT05355701 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: * People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. * People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). 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.
Who can take part
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, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).
- Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies
- Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.
- Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor/EGFR inhibitor allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
- Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor/EGFR inhibitors allowed. Participants with MSI-H/dMMR mCRC should receive prior immune checkpoint inhibitor therapy.
Exclusion criteria
- Brain metastasis larger than 4 cm
- Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.
- Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).
Where it is running
40 locations listed across 11 US states.
- Highlands Oncology Group, PA - Fayetteville, Arkansas, United States
- Highlands Oncology Group, PA - Rogers, Arkansas, United States
- Highlands Oncology Group, PA - Springdale, Arkansas, United States
- Clinical and Translational Research Center (CTRC) - Aurora, Colorado, United States
- UCHealth Sue Anschutz-Rodgers Eye Center - Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) - Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) - Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) - Aurora, Colorado, United States
- Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- University of Miami Hospital and Clinics - Miami, Florida, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Chestnut Hill - Newton, Massachusetts, United States
- Brigitte Harris Cancer Pavilion - Detroit, Michigan, United States
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) - Detroit, Michigan, United States
- Henry Ford Medical Center - Columbus - Novi, Michigan, United States
- CT Scan and Echo Only: Henry Ford Medical Center-Plymouth - Plymouth, Michigan, United States
- MSK Monmouth - Middletown, New Jersey, United States
- MSK David H. Koch Center for Cancer Care - New York, New York, United States
- Memorial Sloan Kettering Cancer Center 53rd street - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Providence Cancer Institute Franz Clinic - Portland, Oregon, United States
- Providence Portland Medical Center - Portland, Oregon, United States
- Sarah Cannon Research Institute - Pharmacy - Nashville, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- TriStar Bone Marrow Transplant - Nashville, Tennessee, United States
- TriStar Centennial Medical Center - Cell Processing Lab - Nashville, Tennessee, United States
- TriStar Centennial Medical center - Nashville, Tennessee, United States
- START San Antonio - San Antonio, Texas, United States
- Hadassah Medical Center - Jerusalem, Israel
- Sheba Medical Center - Ramat Gan, Israel
- Sourasky Medical Center - Tel Aviv, Central District, Israel
- The Ottawa Hospital - General Campus - Ottawa, Ontario, Canada
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- University Health Network - Toronto, Ontario, Canada
- Jewish General Hospital - Montreal, Quebec, Canada
- McGill University Health Centre - Montreal, Quebec, Canada
- Rambam Health Care Campus - Haifa, Ḥeifā, Israel