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Alkylating agents

Nivolumab + Chemotherapy for Anal Cancer

Phase 3
Recruiting
Led By Cathy Eng
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing nivolumab in combination with carboplatin and paclitaxel versus the usual treatment of carboplatin and paclitaxel for anal cancer that has spread to other parts of the body.

Who is the study for?
Adults with metastatic anal squamous cell carcinoma, including those HIV-positive on effective therapy or cured of hepatitis C. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and not pregnant or breastfeeding. Excluded are those with recent major surgery, interstitial lung disease, active infections requiring IV antibiotics, certain autoimmune diseases, or prior systemic chemotherapy for metastatic anal cancer.Check my eligibility
What is being tested?
This phase 3 trial is testing the effectiveness of adding nivolumab (an immunotherapy drug) to standard chemotherapy drugs carboplatin and paclitaxel in treating metastatic anal cancer. The goal is to see if this combination improves outcomes compared to chemotherapy alone.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in organs and infusion reactions. Chemotherapy can lead to hair loss, nausea, fatigue, increased risk of infection due to low blood counts, nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as anal squamous cell carcinoma.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My hepatitis B is under control or being treated effectively.
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I agree not to get any live vaccines during the study.
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I am HIV positive, on ART, with a CD4 count >= 200 or undetectable viral load.
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I am fully active or can carry out light work.
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My cancer cannot be removed by surgery and cannot be cured.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Incidence of adverse events
Objective response rate (ORR)
Overall survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (carboplatin, paclitaxel, nivolumab)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 30 minutes on days 1 and 15 of cycle 1 and then on day 1 only of subsequent cycles, paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles for carboplatin and paclitaxel, and up to 2 years for nivolumab in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (carboplatin, paclitaxel)Active Control2 Interventions
Patients receive paclitaxel IV on days 1, 8, and 15 of each cycle, and carboplatin IV on day 1 of each cycle. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,868 Total Patients Enrolled
Cathy EngPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
238 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04444921 — Phase 3
Anal Squamous Cell Carcinoma Research Study Groups: Arm A (carboplatin, paclitaxel), Arm B (carboplatin, paclitaxel, nivolumab)
Anal Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04444921 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04444921 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers needed for this research project at this time?

"Yes, this is an active trial, as evidenced by the listing on clinicaltrials.gov. It was created on October 15th, 2020 and updated as recently as November 3rd, 2022. They are currently enrolling 205 patients from 100 different sites."

Answered by AI

Is this clinical trial being done in more than one state?

"Mission Cancer and Blood - Laurel in Des Moines, Saint Mary Mercy Hospital in Livonia, McFarland Clinic PC-Jefferson in Jefferson, and 97 other locations are currently recruiting for this trial."

Answered by AI

What cancerous growths does Paclitaxel typically target?

"Paclitaxel is most often administered to patients with malignant neoplasms. Additionally, this medication can be used to treat unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."

Answered by AI

What other medical studies has Paclitaxel been involved in?

"Currently, there are a total of 1914 ongoing studies investigating the efficacy of Paclitaxel. This includes 412 trials that are currently in Phase 3. While several of the studies for Paclitaxel are running out of in São Paulo, Maryland, there are a total of 99059 locations operating studies for Paclitaxel."

Answered by AI

What are some of the dangers associated with Paclitaxel?

"Paclitaxel receive a score of 3 out of 3 for safety. This is due to the fact that it is a Phase 3 trial, signifying that there is both some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

How many people are included in this test group for this clinical trial?

"In order to have a robust sample size, 205 individuals who meet the pre-determined eligibility requirements are needed to sign-up for this study. Participation is possible at sites such as Mission Cancer and Blood - Laurel in Des Moines, Iowa and Saint Mary Mercy Hospital in Livonia, Michigan."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Kaiser Permanente-San Francisco
Memorial Sloan Kettering Westchester
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients
2020. "EA2176: Phase 3 Clinical Trial of Carboplatin and Paclitaxel +/- Nivolumab in Metastatic Anal Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04444921.
All > Anal Cancer
~74 spots leftby Mar 2026
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