Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Sasanlimab for Metastatic Renal Cell Carcinoma

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)

Official registry: https://clinicaltrials.gov/study/NCT07123090 · Stephanie Berg · enrollment listed as 25

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sasanlimab, Palbociclib, or Axitinib. The registry lists allocation as na. 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).

They plan to enroll about 25 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Sasanlimab, Palbociclib, Axitinib

Primary outcome (registry wording): Objective Response Rate (ORR)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • i. The biopsy or resection was performed within 1 year of registration AND
  • 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

Public study contact (from the registry)

Stephanie Berg, DO

617-632-6328

stephaniea_berg@dfci.harvard.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Selected individuals suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease.

NCT00026884 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer

This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck.

NCT00033137 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT07123090 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07123090?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07123090?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary