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ACTIVE NOT RECRUITING Phase 1

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

NCT03172754 · View on ClinicalTrials.gov ↗

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

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

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03172754

The ClinicalTrials.gov registry entry for NCT03172754 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fox Chase Cancer Center, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03172754 reports 4 study locations spanning 3 distinct geographic areas — top geographies include New York, Maryland, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03172754?

The interventions under investigation include: Nivolumab (DRUG), Axitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03172754?

This trial is sponsored by Fox Chase Cancer Center, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial