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.

View Eligibility Criteria

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 B, histological or cytological diagnosis of advanced/metastatic melanoma
For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma,
For Substudy B and C, measurable disease by RECIST version 1.1
For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood
For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)

Exclusion Criteria:

Brain metastasis larger than 4 cm
History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

124

Study ID:

NCT05538130

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 19 Locations for this study

See Locations Near You

Highlands Oncology Group, PA
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers Arkansas, 72758, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale Arkansas, 72762, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
Highlands Oncology
Springdale Arkansas, 72762, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Moffitt McKinley Hospital
Tampa Florida, 33612, United States
Florida Eye Center at Florida Medical Clinic
Tampa Florida, 33613, United States
Brigitte Harris Cancer Pavilion
Detroit Michigan, 48202, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Providence Cancer Institute Franz Clinic
Portland Oregon, 97213, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
McGill University Health Centre
Montréal Quebec, H4A 3, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Quebec City Quebec, G1J 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

124

Study ID:

NCT05538130

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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