A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
SPARCC
A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC
1 other identifier
interventional
25
1 country
2
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
March 25, 2026
March 1, 2026
10 months
August 8, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months
Secondary Outcomes (5)
Grade 3 or Higher Treatment-Related Adverse Event (AE) Rate
AEs will be collected during study treatment, and participants will be followed for 90 days post last treatment administration, or until initiation of new cancer-directed treatment, up to 17 months.
Complete Response Rate (CRR)
Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months
Deep Partial Response Rate
Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months
Median Progression-Free Survival (PFS)
Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months
Median Overall Survival (OS)
Participants will be followed for survival every 6 months after treatment discontinuation, until death or for up to 2 years, whichever comes first. Treatment duration is up to 14 months
Study Arms (1)
Sasanlimab, Axitinib, and Palbociclib
EXPERIMENTALA Bayesian dose-limiting toxicity plan will be employed per protocol with a monitoring time period of the first two cycles of therapy and starting after the first three participants have started protocol therapy. 25 enrolled participants will complete: * Baseline visit with assessments and imaging * Imaging every 8 weeks for 16 weeks, then every 12 weeks * Cycle 1 Through End of Treatment (28 day cycles): * Day 1: Predetermined dose of Sasanlimab 1x daily * Days 1 through 28: Predetermined dose of Axitinib 2x daily, * Days 8 through 28: Predetermined dose of Palbociclib 1x daily * End of treatment visit * Follow up every 6 months for 2 years after treatment discontinuation
Interventions
Recombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol
Cyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol
Vascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible.
- a. For tRCC please refer to the following for eligibility definitions:
- i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable.
- ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded.
- b. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides from a primary or metastatic tumor resection or biopsy) can be provided if the following criteria are met:
- i. The biopsy or resection was performed within 1 year of registration AND
- ii. The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and registration onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides (10 minimum) will be acceptable
- c. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided as per documented regulations, then 15 unstained slides (10 minimum) will be acceptable.
- Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease.
- Age ≥ 18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Normal organ and marrow function as defined below:
- a. Absolute neutrophil count ≥1.5×109/L
- b. Platelets ≥100×109/L
- c. Hemoglobin ≥9g/dL (RBC transfusions allowed)
- +7 more criteria
You may not qualify if:
- Treatment with the following prior therapies:
- a. Prior systemic therapy for advanced or metastatic RCC.
- b. Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred within 12 months of last dose of such therapy. Treatment with an immune checkpoint inhibitor in the adjuvant setting is allowed providing more than 12 months have elapsed since last dose or completion of therapy.
- c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways).
- d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).
- e. Prior therapy with any CDK4/6 inhibitor.
- Participants with untreated brain metastases. Participants with metastatic CNS tumors may participate in this trial, if the participant is ≥ 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy \>10 mg/day prednisone equivalents. A repeat MRI or CT brain to show stability is required.
- Wide field radiation therapy ≤ 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic non-target lesion(s) is permitted if completed at least 48hrs prior to patient registration.
- Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1.
- Major surgery/surgical procedures within the past 4 weeks prior to registration.
- The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease - also see 3.2.22, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
- Current or prior use of immunosuppressive medication within 7 days prior to registration, except the following:
- a. Intranasal, inhaled, topical steroids, or local steroid injections (eg. intra-articular injection).
- b. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent.
- c. Steroids as premedication for hypersensitivity reactions (eg. CT scan premedication).
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stephanie Berglead
- Pfizercollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Berg, DO
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
August 8, 2025
First Posted
August 14, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
February 1, 2028
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.