Actively Recruiting
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
Led by Stephanie Berg · Updated on 2026-03-25
25
Participants Needed
2
Research Sites
114 weeks
Total Duration
On this page
Sponsors
S
Stephanie Berg
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC). The name of the study drugs involved in this research study is: * Sasanlimab (a type of monoclonal antibody) * Palbociclib (a type of kinase inhibitor) * Axitinib (a type of Vascular endothelial growth factor inhibitor)
CONDITIONS
Official Title
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma, including sarcomatoid histology
- For tRCC, confirmation of TFE3 (Xp11.2) translocation or TFEB rearrangement by specific tests
- Availability of formalin-fixed, paraffin-embedded tumor tissue block or recent biopsy slides
- Measurable disease as per RECIST 1.1 criteria
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Normal organ and marrow function meeting specified laboratory values
- Women of child-bearing potential and men must agree to use adequate contraception before and during the study and for 90 days after completion
- Ability to swallow oral medications
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior systemic therapy for advanced or metastatic renal cell carcinoma
- Prior adjuvant or neoadjuvant therapy with disease progression or relapse within 12 months
- Prior immunotherapy or prior therapy with axitinib or CDK4/6 inhibitors in the metastatic setting
- Untreated brain metastases or unstable CNS tumors
- Recent wide field radiation therapy or major surgery within specified time frames
- Untreated deep vein thrombosis or pulmonary embolism
- Serious or uncontrolled medical conditions that would preclude participation
- Current or recent use of immunosuppressive medications except specified exceptions
- Known severe hypersensitivity to monoclonal antibodies or history of anaphylaxis
- Active autoimmune disease worsening with immunostimulatory agents
- Recent vaccination except inactivated vaccines
- Grade 3 or higher hemorrhage within 4 weeks
- Active systemic infections requiring IV antibiotics
- Known active Hepatitis B or C infection
- Prior stem cell or solid organ transplant
- Gastrointestinal conditions affecting drug absorption
- Therapeutic use of warfarin or coumadin derivatives
- Other malignancies diagnosed within 2 years unless low risk
- Certain cardiovascular conditions and recent major cardiovascular events
- History of interstitial lung disease or significant respiratory conditions
- Heavy smoking history over 30 pack-years
- Known hypersensitivity to study drugs or excipients
- Current use of strong CYP3A4/5 inhibitors or inducers
- Use of herbal medications within 7 days prior to treatment
- Pregnant or breastfeeding females
- Investigator judgment of unsuitability or noncompliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Stephanie Berg, DO
CONTACT
B
Bradley McGregor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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