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NCT04444921 · ClinicalTrials.gov registry record · Phase 3

EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients

A Phase 3 study of Stage III Anal Cancer AJCC v8 and Anal Basaloid Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
205
Enrollment target
20
Study locations

NCT04444921 is a Phase 3 study of Stage III Anal Cancer AJCC v8 and Anal Basaloid Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 205 participants. The trial reports 20 study locations across 4 states.

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The verdict

NCT04444921, a Phase 3 study of Stage III Anal Cancer AJCC v8 and Anal Basaloid Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
205 participants
Enrollment target
20
Study locations

Study Summary

This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab together with carboplatin and paclitaxel may help doctors find out if the treatment is better or the same as the usual approach.

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Nivolumab

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • PCR Oncology - Arroyo Grande
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Kaiser Permanente Dublin - Dublin

Arizona

  • Kingman Regional Medical Center - Kingman
  • Cancer Center at Saint Joseph's - Phoenix

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs

Trial Details

FieldValue
Enrollment Target 205 participants
Start Date 2020-11-17
Est. Completion 2027-03-31
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04444921

The ClinicalTrials.gov registry entry for NCT04444921 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 205 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 7 conditions, with Stage III Anal Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.

NCT04444921 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT04444921 about?

NCT04444921 is a clinical study titled "EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients". This phase 3 trial compares the addition of nivolumab to chemotherapy (carboplatin and paclitaxel) versus usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may h...

What is the current status of trial NCT04444921?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 205 participants. The study started on 2020-11-17. Estimated completion is 2027-03-31.

What conditions does trial NCT04444921 study?

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

What interventions are being tested in trial NCT04444921?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Nivolumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04444921?

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

Where is trial NCT04444921 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. 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.