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ACTIVE NOT RECRUITING Phase 2

Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

NCT03241186 · View on ClinicalTrials.gov ↗

Study Summary

This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.

Conditions Studied

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab

Study Locations (7)

Minnesota

  • University of Minnesota — Minneapolis
  • Mayo Clinic Rochester — Rochester

Florida

  • Mayo Clinic- Florida — Jacksonville

Iowa

  • University of Iowa Hospital and Clinics — Iowa City

Nebraska

  • Nebraska Cancer Specialists — Omaha

Oregon

  • Providence Portland Medical Center — Portland

Pennsylvania

  • Fox Chase Cancer Center — Philadelphia

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2017-09-12
Est. Completion 2023-09
Phase Phase 2

Sponsor

Robert R. McWilliams, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03241186

The ClinicalTrials.gov registry entry for NCT03241186 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Robert R. McWilliams, MD, which has 1 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 Mucosal Melanoma 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: NCT03241186 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Minnesota, Florida, Iowa. 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 NCT03241186 about?

NCT03241186 is a clinical study titled "Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma". This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycl...

What is the current status of trial NCT03241186?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2017-09-12. Estimated completion is 2023-09.

What conditions does trial NCT03241186 study?

This clinical trial studies the following conditions: Mucosal Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03241186?

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

Who is sponsoring clinical trial NCT03241186?

This trial is sponsored by Robert R. McWilliams, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03241186 being conducted?

This trial has 7 study locations across Florida, Iowa, Minnesota, Nebraska, Oregon. 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