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OncoMatch/Clinical Trials/NCT05355701

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

Is NCT05355701 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for melanoma.

Phase 1RecruitingPfizerNCT05355701Data as of May 2026

Treatment: PF-07799933 · binimetinib · cetuximab · midazolam · fluorouracil · leucovorin · oxaliplatinThe 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Non-Small Cell Lung Carcinoma

Thyroid Cancer

Glioblastoma

Colorectal Cancer

Biomarker criteria

Required: BRAF V600 mutation

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).

Required: BRAF non-V600 Class II BRAF alteration

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).

Required: BRAF non-V600 Class III BRAF alteration

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 stage

Metastatic disease required

Prior therapy

Must have received:

Disease progressed during/following last prior treatment and no satisfactory alternative treatment options

Must have received: BRAF inhibitor

Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required

Must have received: MEK inhibitor

Part 3 (Cohort 1) (BRAF V600 mutant melanoma): prior MEK inhibitor therapy required

Must have received: immune checkpoint inhibitor

Part 3 (Cohort 1) (BRAF V600 mutant melanoma): immune checkpoint inhibitor therapy required

Must have received: cytotoxic chemotherapy (5-FU)

Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required

Cannot have received: BRAF inhibitor

No prior BRAF inhibitor allowed

Cannot have received: EGFR inhibitor

No prior EGFR inhibitor allowed

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Highlands Oncology Group · Fayetteville, Arkansas
  • Highlands Oncology Group · Rogers, Arkansas
  • Highlands Oncology Group · Springdale, Arkansas
  • Clinical and Translational Research Center (CTRC) · Aurora, Colorado
  • UCHealth Sue Anschutz-Rodgers Eye Center · Aurora, Colorado

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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