Your session is about to expire
← Back to Search
Alkylating agents
Nivolumab + Chemotherapy for Anal Cancer
Phase 3
Waitlist Available
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
Must not have
Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater). These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Patients with any of these are ineligible because of the risk of recurrence or exacerbation of autoimmune disease
Patient must not have a serious active infection requiring IV antibiotics at time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether adding nivolumab to standard chemotherapy is more effective for patients with metastatic anal cancer. Nivolumab helps the immune system fight cancer, while chemotherapy kills or stops cancer cells from growing. Nivolumab has shown significant effectiveness in treating metastatic squamous cell carcinoma of the anal canal.
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.
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.
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 belowSelect...
My cancer is confirmed as anal squamous cell carcinoma.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
My hepatitis B is under control or being treated effectively.
Select...
I agree not to get any live vaccines during the study.
Select...
I am HIV positive, on ART, with a CD4 count >= 200 or undetectable viral load.
Select...
I am fully active or can carry out light work.
Select...
My cancer cannot be removed by surgery and cannot be cured.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have an active or history of severe autoimmune disease.
Select...
I do not have a serious infection needing IV antibiotics now.
Select...
I have never received immunotherapy.
Select...
I do not have a history of lung diseases like pneumonitis or pulmonary fibrosis.
Select...
I do not have severe nerve damage.
Select...
I have no allergies to platinum, taxane chemotherapy, or monoclonal antibodies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival
Secondary study objectives
Incidence of adverse events
Objective response rate (ORR)
Overall survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~5220
Paclitaxel
2011
Completed Phase 4
~5810
Carboplatin
2014
Completed Phase 3
~6120
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.
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.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,732 Total Patients Enrolled
Cathy EngPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
238 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am using or willing to use effective birth control or abstain from sex as required.I am not on high-dose steroids or other immune-weakening drugs.I have had radiation for symptom relief, not on the main cancer area, more than a week ago.I haven't used chemotherapy or trial drugs for my advanced anal cancer.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 3 years.My cancer is confirmed as anal squamous cell carcinoma.I have brain metastasis but no symptoms, and my treatment ended over 3 months ago.My kidney function, measured by creatinine levels or clearance, is within the required range.My hepatitis B is under control or being treated effectively.My heart is healthy enough for the trial, based on recent tests.I agree not to get any live vaccines during the study.I am HIV positive, on ART, with a CD4 count >= 200 or undetectable viral load.I do not have a serious infection needing IV antibiotics now.I am not pregnant or breastfeeding and have confirmed this with a test.I do not have an active or history of severe autoimmune disease.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am fully active or can carry out light work.My cancer cannot be removed by surgery and cannot be cured.My cancer can be measured by scans taken less than 4 weeks ago.I have never received immunotherapy.I have not had major surgery in the last 28 days.I do not have a history of lung diseases like pneumonitis or pulmonary fibrosis.I am 18 years old or older.I do not have severe nerve damage.I have no allergies to platinum, taxane chemotherapy, or monoclonal antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (carboplatin, paclitaxel)
- Group 2: Arm B (carboplatin, paclitaxel, nivolumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger