RECRUITING

A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-30
Study Completion:2028-10-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05538130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
  2. * Measurable disease by RECIST version 1.1
  3. * Evidence of a BRAF V600 mutation
  4. * Prior therapy per tumor cohort
  5. * Adequate organ function per protocol
  1. * Other active malignancy within 3 years
  2. * Presence of leptomeningeal disease
  3. * History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
  4. * Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
  5. * Active gastrointestinal disease as defined per protocol
  6. * History of interstitial lung disease as defined per protocol

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
University of Alabama at Birmingham - Phase I Clinical Trials Unit
Birmingham, Alabama, 35249
United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
United States
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
Los Angeles, California, 90025
United States
Keck Hospital of USC
Los Angeles, California, 90033
United States
Los Angeles General Medical Center
Los Angeles, California, 90033
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Keck Medical Center of USC Pasadena
Pasadena, California, 91105
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
United States
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158
United States
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404
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
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
United States
Methodist Hospital Inpatient Pharmacy
Saint Louis Park, Minnesota, 55426
United States
HealthPartners Cancer Center at regions Hospital
Saint Paul, Minnesota, 55101
United States
Regions Hospital Pharmacy
Saint Paul, Minnesota, 55101
United States
MSK Basking Ridge.
Basking Ridge, New Jersey, 07920
United States
MSK Monmouth.
Middletown, New Jersey, 07748
United States
MSK Bergen.
Montvale, New Jersey, 07645
United States
Optum Medical Care, PC
Brewster, New York, 10509
United States
MSK Commack.
Commack, New York, 11725
United States
MSK Westchester.
Harrison, New York, 10604
United States
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York, New York, 10016
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
United States
NYU Langone Faculty Group Practice
New York, New York, 10016
United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, 10022
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Columbia University Medical Center - Neurological Institute of New York
New York, New York, 10032
United States
CUIMC Research Pharmacy
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
United States
Brooklyn Radiation Oncology, PC
Richmond Hill, New York, 11418
United States
MSK Nassau.
Uniondale, New York, 11553
United States
Clinical Research Alliance
Westbury, New York, 11590
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
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon Research Institute- Pharmacy
Nashville, Tennessee, 37203
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-30
Study Completion Date2028-10-07

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2028-10-07

Terms related to this study

Keywords Provided by Researchers

  • solid tumors
  • BRAF
  • advanced solid tumors
  • B-Raf
  • MAPK
  • neoplasms
  • BRAF V600

Additional Relevant MeSH Terms

  • Melanoma
  • Glioma
  • Thyroid Cancer
  • Non-Small Cell Lung Cancer
  • Malignant Neoplasms
  • Brain Neoplasms
  • Advanced or Metastatic Solid Tumors
  • HGG
  • LGG
  • Low Grade Glioma
  • High Grade Glioma
  • Differentiated Thyroid Cancer
  • NSCLC (Non-small Cell Lung Cancer)