Melanoma Clinical Trial

A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

Summary

First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥16 years at the time of consent
Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
Documented evidence of a BRAF V600 mutation in tumor tissue or blood
Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
Presence or absence of brain involvement unless specified below

Dose Expansion (Part B)

Cohort 1, 2, 3, 4: melanoma with at least 1 parenchymal brain lesion
Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
Optional Cohort 6 (DDI Sub-study) and 7 (Food-Effect): if brain involvement present, must be asymptomatic
Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below

Dose Expansion (Part B)

Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

Brain metastasis/primary brain tumor requiring immediate local intervention
History of or current leptomeningeal metastases
Any other active malignancy within 2 years prior to enrollment
Radiation therapy to visceral metastases within 14 days prior to study treatment. WBRT within 28 days prior to study treatment.
Systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to start of study treatment; Antibody based agents within 4 weeks prior to start of study treatment.
History or current evidence of RVO or current risk factors for RVO; History of retinal degenerative disease

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT04543188

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 49 Locations for this study

See Locations Near You

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
City of Hope Investigational Drug Services (IDS)
Duarte California, 91010, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94143, United States
UCSF Medical Center
San Francisco California, 94158, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa Florida, 33612, United States
Northwestern Medical Group
Chicago Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Community Health Network, Inc.
Indianapolis Indiana, 46250, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
The University of Kansas Cancer Center - Investigational Drug Services
Fairway Kansas, 66205, United States
The University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States
The University of Kansas Hospital
Kansas City Kansas, 66160, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Johns Hopkins University / Johns Hopkins Hospital
Baltimore Maryland, 21231, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Imaging: Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Imaging: Brigham and Women's Radiology, Coolidge Corner Imaging
Brookline Massachusetts, 02446, United States
Imaging: Brigham and Women's Ambulatory Care
Chestnut Hill Massachusetts, 02467, United States
Imaging: Brigham and Women's Mass General Healthcare Center
Foxboro Massachusetts, 02035, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton Massachusetts, 02459, United States
Michigan Health Professionals (PI Clinic)
Farmington Hills Michigan, 48334, United States
Revive Research Institute
Sterling Heights Michigan, 48314, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul Minnesota, 55101, United States
Regions Hospital Pharmacy
Saint Paul Minnesota, 55101, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Siteman Cancer Center - North County
Florissant Missouri, 63031, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University Infusion Center Pharmacy
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - St Peters
Saint Peters Missouri, 63376, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
NYU Langone Health
New York New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York New York, 10016, United States
NYU Langone Radiology- ACC East 41st street
New York New York, 10017, United States
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavilion
New York New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
UNC Cancer Hospital Infusion Pharmacy
Chapel Hill North Carolina, 27514, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27514, United States
Duke Eye Center
Durham North Carolina, 27705, United States
Duke University Medical Center, Investigational Chemotherapy Services
Durham North Carolina, 27710, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Carl & Edyth Lindner Center for Research & Education at TCH and TCH Cancer Center
Cincinnati Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States
West Chester Hospital
West Chester Ohio, 45069, United States
Tennessee Oncology PLLC
Franklin Tennessee, 37067, United States
Sarah Cannon Research Institute - Pharmacy
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Wisconsin Hospitals and Clinics
Madison Wisconsin, 53792, United States
Hamilton Health Sciences-Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Rambam Health Care Campus
Haifa ?eif?, 31096, Israel
Rabin Medical Center
Petah-Tikva Hamerkaz, 49100, Israel
Sheba Medical Center
Ramat Gan Hamerkaz, 52621, Israel
Sourasky Medical Center
Tel Aviv Tell Abīb, 64239, Israel
Hadassah Medical Center
Jerusalem Yerushalayim, 91120, Israel

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT04543188

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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