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A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS

Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b). Phase 1a is no longer open for enrollment. In Phase1b (noted as this study), we are seeking participants who have: * a solid tumor which is metastatic or recurrent (excluding colorectal cancer) * tumor with the mutation (abnormal gene) called BRAF V600 * received required prior treatment for cancer per cohort assigned. All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day. Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)

• Measurable disease by RECIST version 1.1

• Evidence of a BRAF V600 mutation

• Prior therapy per tumor cohort

• Adequate organ function per protocol

Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
NOT_YET_RECRUITING
Birmingham
The University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
University of Alabama at Birmingham - Phase I Clinical Trials Unit
NOT_YET_RECRUITING
Birmingham
Arkansas
Highlands Oncology Group, PA
RECRUITING
Fayetteville
Highlands Oncology Group, PA
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
California
Keck Hospital of USC
NOT_YET_RECRUITING
Los Angeles
Los Angeles General Medical Center
NOT_YET_RECRUITING
Los Angeles
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
RECRUITING
Los Angeles
USC/Norris Comprehensive Cancer Center
NOT_YET_RECRUITING
Los Angeles
Keck Medical Center of USC Pasadena
NOT_YET_RECRUITING
Pasadena
UCSF Helen Diller Medical Center at Parnassus Heights
RECRUITING
San Francisco
UCSF Medical Center, Investigational Pharmacy
RECRUITING
San Francisco
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
RECRUITING
Santa Monica
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
RECRUITING
Tampa
Moffitt McKinley Hospital
RECRUITING
Tampa
Louisiana
Ochsner Clinic Foundation
NOT_YET_RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Michigan
Brigitte Harris Cancer Pavilion
RECRUITING
Detroit
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
HealthPartners Frauenshuh Cancer Center
NOT_YET_RECRUITING
Saint Louis Park
Methodist Hospital Inpatient Pharmacy
NOT_YET_RECRUITING
Saint Louis Park
HealthPartners Cancer Center at regions Hospital
NOT_YET_RECRUITING
Saint Paul
Regions Hospital Pharmacy
NOT_YET_RECRUITING
Saint Paul
New Jersey
MSK Basking Ridge.
RECRUITING
Basking Ridge
MSK Monmouth.
RECRUITING
Middletown
MSK Bergen.
RECRUITING
Montvale
New York
Optum Medical Care, PC
NOT_YET_RECRUITING
Brewster
MSK Commack.
RECRUITING
Commack
MSK Westchester.
RECRUITING
Harrison
Columbia University Irving Medical Center
RECRUITING
New York
Columbia University Medical Center - Neurological Institute of New York
RECRUITING
New York
CUIMC Research Pharmacy
RECRUITING
New York
Laura & Isaac Perlmutter Cancer Center - NYU ACC
RECRUITING
New York
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING
New York
Memorial Sloan Kettering Cancer Center 53rd street.
RECRUITING
New York
NYU Langone Faculty Group Practice
RECRUITING
New York
NYU Langone Medical Center (Tisch Hospital)
RECRUITING
New York
Brooklyn Radiation Oncology, PC
NOT_YET_RECRUITING
Richmond Hill
MSK Nassau.
RECRUITING
Uniondale
Clinical Research Alliance
NOT_YET_RECRUITING
Westbury
Ohio
Cleveland Clinic Taussig Cancer Center
RECRUITING
Cleveland
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
RECRUITING
Cleveland
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Pennsylvania
UPMC Hillman Cancer Center
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Sarah Cannon Research Institute- Pharmacy
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
University of Washington Medical Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Parkville
Brazil
ANIMI - Unidade de Tratamento Oncologico
RECRUITING
Lages
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
RECRUITING
São Caetano Do Sul
IBCC - Núcleo de Pesquisa e Ensino
RECRUITING
São Paulo
Canada
Alberta Health Services and The Governors of The University of Alberta
RECRUITING
Edmonton
Cross Cancer Institute
RECRUITING
Edmonton
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
China
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Israel
Soroka Medical Center
RECRUITING
Beersheba
Hadassah Medical Center
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Japan
Kansai Medical University Hospital
NOT_YET_RECRUITING
Hirakata
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-11-30
Estimated Completion Date: 2028-11-24
Participants
Target number of participants: 124
Treatments
Experimental: Phase 1a Monotherapy Dose Escalation
Participants will receive PF-07799544
Experimental: Phase 1b Combination Dose Escalation
Participants will receive PF-07799544 and PF-07799933
Experimental: Phase 1b Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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