Actively Recruiting
A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC
Led by Stephanie Berg · Updated on 2026-03-25
25
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
S
Stephanie Berg
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well and safely the drugs sasanlimab, palbociclib, and axitinib work for treating people with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC). This Phase 2 study focuses on these advanced kidney cancers, with sasanlimab and palbociclib being investigational for this use, while axitinib is an approved treatment for ccRCC. The combination of all three drugs is not yet approved for these conditions. Participants will receive a combination of three drugs: sasanlimab by injection under the skin daily starting Day 1; axitinib tablets twice daily starting Day 1; and palbociclib tablets once daily starting Day 8 through Day 28 of each 28-day treatment cycle. The study includes a baseline visit, imaging every 8 weeks for 16 weeks, then every 12 weeks, and an end of treatment visit. After treatment ends, participants will be followed up every 6 months for 2 years. Participants will have screening and regular visits including questionnaires, blood and urine tests, imaging scans, and heart monitoring with electrocardiograms. Disease status will be assessed every 8 weeks initially, then every 12 weeks, to track tumor response. Safety is monitored throughout treatment and for 90 days after the last dose. Survival follow-up will continue every 6 months for up to 2 years. The total treatment duration can be up to 14 months, with close monitoring during and after therapy.
CONDITIONS
Brief 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
- Measurable disease as per RECIST 1.1 criteria
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Normal organ and marrow function including specific blood counts and liver and kidney function
- Women of child-bearing potential and men must agree to use adequate contraception before and during study participation and for 90 days after treatment ends
- Ability to swallow oral medications
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior systemic therapy for advanced or metastatic renal cell carcinoma
- Prior adjuvant or neoadjuvant therapy for renal cell carcinoma if disease progressed or relapsed within 12 months
- Prior treatment with any immunotherapeutic agent or CDK4/6 inhibitor
- Untreated brain metastases or unstable CNS tumors
- Recent wide field radiation therapy or major surgery within specified timeframes
- Untreated deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start
- Serious uncontrolled medical conditions such as severe lung disease, severe heart problems, or active infections
- Current or recent use of immunosuppressive medications except certain steroids or injections
- Known severe allergic reactions to monoclonal antibodies or history of anaphylaxis
- Active autoimmune disease requiring immunosuppressive treatment
- Recent vaccinations with live vaccines
- Grade 3 or higher bleeding within 4 weeks
- Known active infections including HIV or active Hepatitis B or C
- Prior stem cell or organ transplant
- Gastrointestinal conditions affecting drug absorption
- Current use of strong CYP3A4/5 inhibitors or inducers within specified times
- Recent use of herbal medications
- Pregnant or breastfeeding women
- History of significant cardiovascular events within 6 months
- Tobacco use history greater than 30 pack-years
- Known hypersensitivity to study drugs or excipients
- Investigator judgment of unsuitability or likely non-compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 months
Participants receive the study drugs sasanlimab, palbociclib, and axitinib in repeated 28-day cycles while undergoing regular assessments including imaging.
Imaging every 8 weeks for the first 16 weeks, then every 12 weeks; assessments during each 28-day treatment cycle
Duration - Up to 2 years after treatment ends
Participants are followed every 6 months for up to 2 years after treatment discontinuation to monitor survival and safety.
Visits every 6 months
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
B
Bradley McGregor, MD
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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