What side effects are associated with this type of intervention?

Common treatments for Anal Squamous Cell Carcinoma include chemotherapy (e.g., carboplatin and paclitaxel) and immunotherapy with monoclonal antibodies such as Nivolumab. The side effects of chemotherapy can include nausea, vomiting, hair loss, fatigue, and increased risk of infection. Immunotherapy with Nivolumab can lead to immune-related adverse events such as skin rashes, colitis, hepatitis, endocrinopathies, and pneumonitis. These side effects arise from the enhanced immune response targeting not only cancer cells but also normal tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for Anal Squamous Cell Carcinoma, primarily focusing on chemotherapy regimens. However, recent clinical trials, such as the one involving Nivolumab, are exploring the efficacy of immunotherapy with monoclonal antibodies. Nivolumab, an anti-PD-1 monoclonal antibody, is being studied in combination with chemotherapy agents like carboplatin and paclitaxel to enhance the immune system's ability to attack cancer cells and inhibit tumor growth and spread. This approach represents a promising advancement in the treatment landscape for metastatic anal cancer.

What other types of research exist?

Promising novel alternatives to Nivolumab for Anal Squamous Cell Carcinoma patients include other immune checkpoint inhibitors like Pembrolizumab and Atezolizumab, therapeutic vaccines targeting HPV, engineered T cells such as CAR-T cells, and antibody-drug conjugates. These treatments are in various stages of clinical development and may offer new options for patients in 2024.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Anal Squamous Cell Carcinoma include chemotherapy and immunotherapy. Chemotherapy agents like carboplatin and paclitaxel work by killing cancer cells, inhibiting their division, and preventing their spread. Immunotherapy, particularly with monoclonal antibodies such as nivolumab, boosts the immune system's ability to attack cancer cells by targeting proteins that tumors use to evade immune detection. This combination of therapies is crucial for patients as it not only directly targets and destroys cancer cells but also enhances the body's natural immune response, potentially improving overall treatment efficacy and outcomes.

Human Papillomavirus Induced Cervical and Oropharyngeal Cancers: From Mechanisms to Potential Immuno-therapeutic Strategies.Cytoreductive treatment strategies for de novo metastatic prostate cancer.The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.