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A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma

A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC

NCT07123090•Stephanie Berg

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)

Detailed Description

This single arm, Phase 2 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 U.S. Food and Drug Administration (FDA) has not approved sasanlimab or palbociclib as a treatment option for ccRCC or tRCC. The U.S. FDA has approved axitinib as a treatment option for ccRCC. The U.S. FDA has not approved the combination of sasanlimab, axitinib, and palbociclib for ccRCC or tRCC. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, urine tests, imaging scans, and electrocardiograms (ECGs). It is expected that about 25 people will take part in this research study. Pfizer, is supporting this research study by providing funding and the study drugs, sasanlimab, palbociclib, and axitinib.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+12 more criteria

Exclusion Criteria

•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.
+26 more criteria

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

October 1, 2026

Completion Date

February 1, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Metastatic Renal Cell CarcinomaMetastatic Renal CancerRenal Cell CarcinomaAdvanced Clear Cell Renal Cell CarcinomaKidney CancerTranslocation Renal Cell Carcinoma

Interventions

Sasanlimab

DRUG

Palbociclib

DRUG

Axitinib

DRUG

Contacts

Stephanie Berg, DO

CONTACT

617-632-6328 stephaniea_berg@dfci.harvard.edu

Bradley McGregor, MD

CONTACT

1-877-DF-TRIAL Bradley_McGregor@DFCI.HARVARD.EDU

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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