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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Stephanie Berg
Study ID
NCT07123090
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sasanlimab — DRUG
    Recombinant humanized monoclonal antibody, prefilled syringe, subcutaneous (under the skin) injection per protocol
  • Palbociclib — DRUG
    Cyclin-dependent kinase (CDK) 4/6 inhibitor, tablet taken orally per protocol
  • Axitinib — DRUG
    Vascular endothelial growth factor (VEGF) inhibitor, tablet taken orally per standard of care

Study Details

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)

Key Dates

Start date
Nov 24, 2025
Status verified
Mar 2026
Primary completion
Oct 1, 2026
Completion
Feb 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sasanlimab, Axitinib, and Palbociclib
    A 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

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Disease assessment will be performed every 8 weeks for the first 16 weeks, then every 12 weeks on treatment for up to 14 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Stephanie Berg, DO
[email protected]
617-632-6328
Stephanie Berg, DO (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Stephanie Berg, DO
[email protected]
617-632-6328
Stephanie Berg, DO (PRINCIPAL_INVESTIGATOR)

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