MedTrace Logo

Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

NCT05188118 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-06

No results posted yet for this study

Summary

This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).

Conditions

Interventions

DRUG

Cabozantinib

60mg oral once daily for 12 weeks

DRUG

Ipilimumab

1mg/kg intravenous once every 3 weeks over 12 weeks

DRUG

Nivolumab

3mg/kg intravenous once every 3 weeks over 12 weeks, then 480mg once every 4 weeks after

DRUG

Lenvatinib

18mg oral once daily for 12 weeks

DRUG

Everolimus

5mg oral once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Che-Kai Tsao · Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188118 on ClinicalTrials.gov