AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
Summary
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them. To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer. Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
Arms & interventions
- DrugPF-08634404
Concentrate for solution for infusion
- DrugIpilimumab
Solution for infusion
- DrugAxitinib
Tablet
Outcome measures
Primary
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.
Time frame: Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Time frame: Through 90 days after the last study intervention (Up to approximately 3 years)
Number of participants with dose limiting toxicity (DLT)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Time frame: Though end of DLT evaluation period (Up to approximately 3 years)
Secondary
Duration of Response (DOR) per RECIST v1.1 by investigator
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
Pharmacokinetics (PK): Serum concentration of PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Time frame: Up to 37 days after the last dose of treatment
Eligibility criteria
Study locations (101)
Mayo Clinic Building- Phoenix
Phoenix, Arizona, 85054
Mayo Clinic
Scottsdale, Arizona, 85259
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Highlands Oncology Group
Rogers, Arkansas, 72758
Highlands Oncology Group
Springdale, Arkansas, 72762
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010
UC San Diego Medical Center - Encinitas
Encinitas, California, 92024
City of Hope Investigational Drug Services (IDS)
Irvine, California, 92618
City of Hope
Irvine, California, 92618
UC San Diego / Moores Cancer Center
La Jolla, California, 92037
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, 92037
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037
City of Hope
Long Beach, California, 90813
UC San Diego Medical Center - Bankers Hill
San Diego, California, 92101
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, 92103
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, 92127
City of Hope UPLAND
Upland, California, 91786
UC San Diego Medical Center - Vista
Vista, California, 92081
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Mayo Clinic Pharmacy
Jacksonville, Florida, 32224
Tennessee Oncology, PLLC- Ringgold
Ringgold, Georgia, 30736
City Of Hope - Chicago
Zion, Illinois, 60099
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337
Minnesota Oncology Hematology, P.A.
Chaska, Minnesota, 55318
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109
Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
Rochester, Minnesota, 55902
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, 55905
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
MSK Monmouth
Middletown, New Jersey, 07748
MSK Bergen
Montvale, New Jersey, 07645
New York Oncology Hematology, P.C.
Albany, New York, 12206
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, 12065
MSK Commack
Commack, New York, 11725
MSK Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, 11101
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, 10065
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, 10065
MSK Nassau
Uniondale, New York, 11553
Grand Strand Medical Center
Myrtle Beach, South Carolina, 295724607
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572
Tennessee Oncology, PLLC- Chattanooga Downtown
Chattanooga, Tennessee, 37403
Tennessee Oncology, PLLC - Chattanooga Med Park II
Chattanooga, Tennessee, 37404
Tennessee Oncology, PLLC - Chattanooga Memorial
Chattanooga, Tennessee, 37404
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
Chattanooga, Tennessee, 37404
Tennessee Oncology, PLLC- Chattanooga East
Chattanooga, Tennessee, 37421
Tennessee Oncology, PLLC- Cookeville
Cookeville, Tennessee, 38501
Tennessee Oncology, PLLC-Dickson
Dickson, Tennessee, 37055
Tennessee Oncology, PLLC- Franklin Proton Center
Franklin, Tennessee, 37067
Tennessee Oncology, PLLC-Franklin
Franklin, Tennessee, 37067
Tennessee Oncology, PLLC-Gallatin
Gallatin, Tennessee, 37066
Tennessee Oncology, PLLC-Hendersonville
Hendersonville, Tennessee, 37075
Tennessee Oncology, PLLC-Lebanon
Lebanon, Tennessee, 37090
Tennessee Oncology, PLLC-Mount Juliet
Mount Juliet, Tennessee, 37122
Tennessee Oncology, PLLC-Murfreesboro
Murfreesboro, Tennessee, 37129
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC- Elliston Place Plaza
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC-Investigational Drug Services
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC- Saint Thomas West
Nashville, Tennessee, 37205
Tennessee Oncology, PLLC- Skyline
Nashville, Tennessee, 37207
Tennessee Oncology, PLLC- Southern Hills
Nashville, Tennessee, 37211
Tennessee Oncology, PLLC- Shelbyville
Shelbyville, Tennessee, 37160
Tennessee Oncology, PLLC- Smyrna
Smyrna, Tennessee, 37167
Texas Oncology - Central South
Austin, Texas, 78705
Texas Oncology - Central South
Austin, Texas, 78731
Texas Oncology - Central South
Austin, Texas, 78745
Texas Oncology - Central South
Austin, Texas, 78758
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
Texas Oncology - Central South
Harlingen, Texas, 78550
Texas Oncology - Gulf Coast
Houston, Texas, 77024
Texas Oncology - Gulf Coast
Houston, Texas, 77054
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
US Oncology Investigational Products Center
Irving, Texas, 75063
Texas Oncology - Central South
McAllen, Texas, 78503
Texas Oncology - Gulf Coast
Pearland, Texas, 77584
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Texas Oncology - Central South
Waco, Texas, 76712
Texas Oncology - Gulf Coast
Webster, Texas, 77598
Texas Oncology - Central South
Weslaco, Texas, 78596
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Minnesota Oncology Hematology, P.A.
Hudson, Wisconsin, 54016