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NCT03172754 · ClinicalTrials.gov registry record · Phase 1

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

A Phase 1 study of Renal Cell Carcinoma, sponsored by Fox Chase Cancer Center.

Active
Registry status
Phase 1
Development phase
98
Enrollment target
4
Study locations

NCT03172754 is a Phase 1 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Fox Chase Cancer Center. The registered enrollment target is 98 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (60% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT03172754, a Phase 1 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Fox Chase Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
98 participants
Enrollment target
4
Study locations

Study Summary

This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.

Conditions Studied

Renal Cell Carcinoma

Interventions

  • DRUG Nivolumab
  • DRUG Axitinib

Study Locations (4)

New York

  • US Oncology and Hematology - Albany
  • Cornell - New York

Maryland

  • Johns Hopkins - Baltimore

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2017-06-12
Est. Completion 2026-10-06
Phase Phase 1

Sponsor

Fox Chase Cancer Center

183 total trials

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What the Registry Record Tells You About NCT03172754

The ClinicalTrials.gov registry entry for NCT03172754 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (60% lower). The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT03172754 reports 4 study locations spanning 3 distinct geographic areas - top geographies include New York, Maryland, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03172754 about?

NCT03172754 is a clinical study titled "Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma". This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding ph...

What is the current status of trial NCT03172754?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2017-06-12. Estimated completion is 2026-10-06.

What conditions does trial NCT03172754 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma.

What interventions are being tested in trial NCT03172754?

The interventions under investigation include: Nivolumab (DRUG), Axitinib (DRUG).

Who is sponsoring clinical trial NCT03172754?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03172754 being conducted?

This trial has 4 study locations across Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.