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Nivolumab for Anal Cancer
Phase 3
Waitlist Available
Led By Lakshmi Rajdev
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
REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Age >= 18 years
REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA: Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the American Joint Committee on Cancer (AJCC) 8th edition; this may include tumors of non-keratinizing histology such as basaloid, transitional cell, or cloacogenic histology; individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal
Must not have
Receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
T1 or M1, and T2N0 cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial tests how well nivolumab works in treating patients with anal cancer after they've received other treatments. Nivolumab may help the body's immune system attack the cancer, and may prevent tumor cells from growing and spreading.
Who is the study for?
Adults with high-risk stage II-IIIB anal cancer who have not had prior immune checkpoint inhibitor therapy, no recent transplants, autoimmune disease, or other cancers. HIV+ patients are eligible if well-managed. Participants must meet specific blood count and organ function criteria and agree to contraception.
What is being tested?
The trial is testing the effectiveness of nivolumab as an immunotherapy after standard treatment for anal cancer. It aims to see if nivolumab can help the immune system attack cancer cells better and prevent the disease from spreading.
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs, potential lung issues (pneumonitis), fatigue, skin reactions, hormone gland problems (like thyroid dysfunction), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer is a specific type and stage of anal or anorectal cancer.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.
Select...
I am HIV positive with a CD4 count over 200 and a viral load under 200.
Select...
I am receiving proper treatment for HIV under a specialist's care.
Select...
I have never been treated with immune checkpoint inhibitors.
Select...
I have tested negative for TB or completed TB prevention treatment.
Select...
I am able to care for myself and perform daily activities.
Select...
My cancer is a specific stage and type affecting the anus or rectum.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any other cancer treatments or experimental drugs with the study drugs.
Select...
My cancer is in an early or advanced stage but hasn't spread to nearby lymph nodes.
Select...
I have lung disease that could affect my treatment.
Select...
I have had a bone marrow, stem cell, or organ transplant from a donor.
Select...
I had surgery to remove anal cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease free survival
Secondary study objectives
Incidence of toxicities
Objective response rate
Severe toxicity interval
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (clinical observation)Experimental Treatment10 Interventions
Patients undergo observation while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.
Group II: Arm A (nivolumab)Experimental Treatment11 Interventions
Patients receive nivolumab while on study. Patients undergo sigmoidoscopy, colonoscopy or anoscopy, proctoscopy or digital rectal exam, x-ray, CT scan, MRI, biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Sigmoidoscopy
2007
Completed Phase 2
~140
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biopsy
2014
Completed Phase 4
~1090
Colonoscopy
2012
Completed Phase 3
~115560
Computed Tomography
2017
Completed Phase 2
~2740
Proctoscopy
2012
Completed Phase 1
~10
High Resolution Anoscopy
2010
N/A
~620
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupNETWORK
127 Previous Clinical Trials
67,930 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,656 Total Patients Enrolled
Lakshmi RajdevPrincipal InvestigatorECOG-ACRIN Cancer Research Group
4 Previous Clinical Trials
349 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test taken within 2 weeks before the study shows that your ANC level is above 1500/mm^3.I am not taking any other cancer treatments or experimental drugs with the study drugs.Your liver enzymes (AST and ALT) should not be more than 2.5 times the normal level. This will be checked within 2 weeks before you enroll in the study.I am 18 years old or older.My cancer is a specific type and stage of anal or anorectal cancer.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.My last surgery was more than 4 weeks ago.I am HIV positive with a CD4 count over 200 and a viral load under 200.I haven't received any live vaccines in the last 30 days.I have had chemoradiotherapy for anal cancer before.I have lung disease that could affect my treatment.I am receiving proper treatment for HIV under a specialist's care.I will use or am using effective birth control or abstaining from sex during and for 5 months (if female) or 7 months (if male) after treatment.I do not have any untreated or uncontrolled illnesses.I have never been treated with immune checkpoint inhibitors.I am not on high-dose steroids or drugs that weaken my immune system.My cancer is in an early or advanced stage but hasn't spread to nearby lymph nodes.Your bilirubin levels must be within normal range before enrolling in the study.Your blood test results show that you have enough platelets, with a count over 100,000/mm^3 taken within 2 weeks prior to registration.You are currently pregnant or breastfeeding.I have tested negative for TB or completed TB prevention treatment.I am healthy despite HIV, but have anal cancer.I am able to care for myself and perform daily activities.I have had a bone marrow, stem cell, or organ transplant from a donor.You have had an autoimmune disease within the last 2 years that has been active.Your hemoglobin levels must be higher than 9 g/dL within two weeks before you join the study.I haven't had AIDS complications in the last year, except for a low CD4+ count before starting HIV treatment.I have mild diarrhea and tests for parasites are negative.I have not had any cancer except for skin cancer or cervical cancer in situ in the last 2 years.My cancer is a specific stage and type affecting the anus or rectum.Your blood albumin levels must be at least 3.0 g/dL within 2 weeks before registering.Your kidney function, as measured by a blood test called serum creatinine, should be normal or mildly impaired.I had surgery to remove anal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (nivolumab)
- Group 2: Arm B (clinical observation)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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