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NCT05188118 · ClinicalTrials.gov registry record · Early Phase 1
Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
A Early Phase 1 study of Renal Cell Carcinoma, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05188118: Recruiting Early Phase 1 study of Renal Cell Carcinoma, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05188118 is a Early Phase 1 study of Renal Cell Carcinoma that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05188118, a Early Phase 1 study of Renal Cell Carcinoma, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).
Primary Outcome
ORR is defined as the proportion of subjects who achieved a best response of CR or PR using the RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameters
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Everolimus
- DRUG Cabozantinib
- DRUG Lenvatinib
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What NCT05188118 shows while recruiting
NCT05188118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Nivolumab is the first listed.
NCT05188118 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05188118 about?
NCT05188118 is a clinical study titled "Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma". 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 t...
What is the current status of trial NCT05188118?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-02-15. Estimated completion is 2026-12.
What conditions does trial NCT05188118 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT05188118?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Everolimus (DRUG), Cabozantinib (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT05188118?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05188118 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05188118's enrollment target sits among peer trials
20 109th of 121 higher than 10 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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