RECRUITING

A Study to Learn About the Study Medicine Called PF-07799544 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) 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 or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, 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.

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 ADVANCED SOLID TUMORS

Quick Facts

Study Start:2022-11-30
Study Completion:2029-08-21
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 including primary brain tumor for monotherapy phase 1a dose escalation
  2. * Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
  3. * For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma
  4. * For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma,
  5. * For Substudy B and C, measurable disease by RECIST version 1.1
  6. * For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood
  7. * For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)
  1. * Brain metastasis larger than 4 cm
  2. * History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

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)

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
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
MSK Commack.
Commack, New York, 11725
United States
MSK Westchester.
Harrison, New York, 10604
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
CUIMC Research Pharmacy
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
United States
MSK Nassau.
Uniondale, New York, 11553
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
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

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 Date2029-08-21

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2029-08-21

Terms related to this study

Keywords Provided by Researchers

  • Proto-Oncogene Proteins B-raf
  • Brain neoplasms
  • Melanoma
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm by Histologic Type
  • CRC
  • MAPK

Additional Relevant MeSH Terms

  • Melanoma
  • Glioma
  • Thyroid Cancer
  • Non-Small Cell Lung Cancer
  • Malignant Neoplasms
  • Brain Neoplasms
  • Colorectal Cancer