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NCT02314169 · ClinicalTrials.gov registry record · Phase 2

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

A Phase 2 study of Anal Canal Squamous Cell Carcinoma and Stage IV Anal Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
37
Enrollment target
20
Study locations

NCT02314169 is a Phase 2 study of Anal Canal Squamous Cell Carcinoma and Stage IV Anal Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants. The trial reports 20 study locations across 5 states.

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The verdict

NCT02314169, a Phase 2 study of Anal Canal Squamous Cell Carcinoma and Stage IV Anal Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
37 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Connecticut

  • Smilow Cancer Hospital-Derby Care Center - Derby
  • Smilow Cancer Hospital Care Center-Fairfield - Fairfield
  • Smilow Cancer Hospital Care Center - Guilford - Guilford
  • Smilow Cancer Hospital Care Center at Saint Francis - Hartford
  • Smilow Cancer Center/Yale-New Haven Hospital - New Haven
  • Yale University - New Haven
  • Yale-New Haven Hospital North Haven Medical Center - North Haven
  • Smilow Cancer Hospital-Torrington Care Center - Torrington
  • Smilow Cancer Hospital Care Center-Trumbull - Trumbull
  • Smilow Cancer Hospital-Waterbury Care Center - Waterbury
  • Smilow Cancer Hospital Care Center - Waterford - Waterford

Illinois

  • Northwestern University - Chicago
  • University of Chicago Comprehensive Cancer Center - Chicago
  • Decatur Memorial Hospital - Decatur
  • UC Comprehensive Cancer Center at Silver Cross - New Lenox

California

  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • University of California Davis Comprehensive Cancer Center - Sacramento

Colorado

  • UCHealth University of Colorado Hospital - Aurora

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2015-05-13
Est. Completion 2026-03-21
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02314169

The ClinicalTrials.gov registry entry for NCT02314169 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Anal Canal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02314169 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Connecticut, Illinois, California.

Frequently Asked Questions

What is clinical trial NCT02314169 about?

NCT02314169 is a clinical study titled "Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer". This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy...

What is the current status of trial NCT02314169?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2015-05-13. Estimated completion is 2026-03-21.

What conditions does trial NCT02314169 study?

This clinical trial studies the following conditions: Anal Canal Squamous Cell Carcinoma, Stage IV Anal Cancer AJCC v8, Metastatic Anal Canal Carcinoma.

What interventions are being tested in trial NCT02314169?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02314169?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02314169 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.