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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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My cancer is a specific type and stage of anal or anorectal cancer.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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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.
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I have never been treated with immune checkpoint inhibitors.
Select...
I have tested negative for TB or completed TB prevention treatment.
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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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival
Secondary outcome measures
Colostomy-free survival
Incidence of toxicities
Objective response rate
+2 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
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
Sigmoidoscopy
2007
Completed Phase 2
~140
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Colonoscopy
2012
Completed Phase 3
~115560
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Proctoscopy
2012
Completed Phase 1
~10
High Resolution Anoscopy
2010
N/A
~620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupNETWORK
124 Previous Clinical Trials
67,109 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,809 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain what other similar research has been conducted using Nivolumab?
"Nivolumab was first trialled in 2010 at H. Lee Moffitt Cancer Center and Research Institute. As of now, there have been a total of 241 completed trials. Additionally, there are currently 751 actively recruiting studies, with a large number of these trials running out of Hixson, Tennessee."
Answered by AI
Are there any available spots left to participate in this research project?
"According to the latest update on clinicaltrials.gov, this clinical trial is not currently enrolling patients. Although the trial was last updated on 9/23/2022, there are 3328 other trials that are still recruiting patients."
Answered by AI
What are some common illnesses that Nivolumab has been known to help?
"Nivolumab is an effective treatment for patients with malignant neoplasms, unresectable melanoma, or squamous cell carcinoma."
Answered by AI
What is the most significant hazard associated with Nivolumab?
"We believe that Nivolumab is safe to use based on its classification as a Phase 3 drug. This means that there is some evidence to support its efficacy, and multiple rounds of data support its safety."
Answered by AI
At how many facilities is this experiment being conducted?
"A few of the 100 locations where this study is being conducted are the Pulmonary Medicine Center of Chattanooga-Hixson in Hixson, Tennessee, Licking Memorial Hospital in Newark, Nevada, and Summerlin Hospital Medical Center in Las Vegas, Oregon."
Answered by AI
Is this research project an original investigation?
"751 clinical trials evaluating the efficacy of nivolumab are underway as of now. They are being conducted in 2357 cities across 50 different nations. The first such study began in 2010 and was sponsored by Medarex. 127 individuals participated in the Phase 1 trial which successfully completed. In the decade since, 241 more trials have been completed."
Answered by AI
Who else is applying?
What site did they apply to?
Tom Baker Cancer Centre
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve had a durable complete response to chemo and would like to keep the cancer from returning.
PatientReceived 1 prior treatment
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