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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05188118
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    60mg oral once daily for 12 weeks
  • Ipilimumab — DRUG
    1mg/kg intravenous once every 3 weeks over 12 weeks
  • Nivolumab — DRUG
    3mg/kg intravenous once every 3 weeks over 12 weeks, then 480mg once every 4 weeks after
  • Lenvatinib — DRUG
    18mg oral once daily for 12 weeks
  • Everolimus — DRUG
    5mg oral once daily for 12 weeks

Study Details

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 \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).

Key Dates

Start date
Feb 15, 2023
Status verified
Nov 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Patients with metastatic or unresectable clear cell renal cell carcinoma
    Patients with metastatic or unresectable clear cell renal cell carcinoma to 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 \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).

Primary Outcome Measure

Best Overall Response Rate (ORR) [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Che-Kai Tsao, MD
[email protected]
212-824-8536
Lindsay Diamond, NP
[email protected]
347-514-1561
Chei-Kai Tsao, MD

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