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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Anal Cancer

Phase 2
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
Patients must have measurable disease according to the standard Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CT scans or MRIs used to assess the measurable disease must have been completed within 28 days prior to study drug initiation
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 80%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing nivolumab with or without ipilimumab to see if it can treat anal canal cancer that has not responded to other treatments and has spread to other parts of the body.

Who is the study for?
This trial is for adults with metastatic anal canal cancer that hasn't improved after treatment. Participants must have adequate organ function, agree to contraception, and be willing to undergo HIV/hepatitis testing. Exclusions include recent chemotherapy, other investigational drugs, allergies to similar compounds, uncontrolled illnesses, certain prior cancers unless in remission for three years or more.Check my eligibility
What is being tested?
The study examines the effectiveness of nivolumab alone or combined with ipilimumab in treating refractory metastatic anal canal cancer. These are immunotherapy drugs designed to help the immune system fight cancer by blocking tumor growth and spread.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting organs like the liver or lungs, infusion reactions from the drug entering the body, fatigue, skin issues such as rash or itching, digestive problems like diarrhea or colitis (inflammation of colon), hormonal gland problems leading to changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by scans and was checked within the last 28 days.
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I am fully active or have some restrictions but can still care for myself.
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I have had at least one treatment for advanced anal cancer that cannot be cured.
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My cancer is a type of anal cancer that has spread and was previously treated.
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I am 18 years old or older.
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I am fully active or able to carry out light work.
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I am HIV positive with a good immune status, undetectable virus, and on HAART.
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I am 18 years old or older.
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I've had at least one treatment for advanced anal cancer and waited the required time before starting a new treatment.
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I have had treatment for metastatic anal canal cancer before.
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My kidney function, measured by creatinine levels or clearance, is within the required range.

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
Overall response rate: number of participants with response (Part A)
Progression-free survival (PFS) (Part B)
Secondary outcome measures
Incidence of grade 3/4/5 adverse events (Part B)
Number of participants with toxicities (Part A)
Overall response rates (Part B)
+2 more
Other outcome measures
Expression of biomarkers using immunohistochemistry and blood samples (Part A)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
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%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
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

3Treatment groups
Experimental Treatment
Group I: Part B Arm II (nivolumab, ipilimumab)Experimental Treatment5 Interventions
Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Group II: Part B Arm I (nivolumab)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.
Group III: Part A (nivolumab)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI 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 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Ipilimumab
2014
Completed Phase 3
~2640
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,509 Total Patients Enrolled
Cathy EngPrincipal InvestigatorYale University Cancer Center LAO
3 Previous Clinical Trials
306 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02314169 — Phase 2
Anal Squamous Cell Carcinoma Research Study Groups: Part A (nivolumab), Part B Arm I (nivolumab), Part B Arm II (nivolumab, ipilimumab)
Anal Squamous Cell Carcinoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02314169 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02314169 — Phase 2

Frequently Asked Questions

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

Is this experiment currently accepting participants?

"Contrary to popular belief, this experiment is not seeking out subjects as of now. The initial posting was on May 1st 2015 and the latest update occurred October 18th 2022. Although recruitment for this medical trial has been suspended, there are 3349 other trials actively looking for volunteers."

Answered by AI

Has the Food and Drug Administration sanctioned Nivolumab for therapeutic use?

"Our internal research team at Power assigned nivolumab a score of 2, as this is only in its second phase of testing and there are indications that the treatment may be safe but no evidence yet to confirm efficacy."

Answered by AI

Are there numerous venues executing this investigation in Canada?

"For this medical trial, potential participants can register at Wayne State University/Karmanos Cancer Institute in Detroit (MI), M D Anderson Cancer Center in Houston (TX), Smilow Cancer Hospital Care Center - Guiford in Guilford (CT) and 46 other locations."

Answered by AI

What other research endeavors have been conducted regarding Nivolumab?

"Currently, there are 765 ongoing studies of Nivolumab with 86 in the most advanced Phase 3. Conveniently for those living nearby, Pittsburgh is a hub for this research; however, trials can be found at 42708 sites around the globe."

Answered by AI

What is the central goal of this clinical experiment?

"The primary endpoint of this clinical trial, which will be monitored over a two year period, is Progression-free survival (PFS). Secondary objectives measure the number and severity of adverse events by observing patients' responses to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0., Grade 3/4/5 adverse event incidences according to CTCAE v.5.0, and overall response rates based on CT scans or magnetic resonance imaging in accordance with RECIST 1.1 criteria; complete remission requires disappearance all target lesions and any pathological lymph nodes reduction under 10 mm (< 1 cm), partial remission demands a"

Answered by AI

What is the current size of the population enrolled in this experiment?

"This trial is no longer soliciting patients. Initially posted on May 1st 2015 and last revised October 18th 2022, it has since been supplanted by other research initiatives. As of now, there are 2584 clinical studies actively enrolling participants with carcinoma and 765 trials for Nivolumab recruiting volunteers."

Answered by AI

To what illnesses is Nivolumab typically prescribed?

"Nivolumab, a popular drug for cancer treatments and countering the effects of anti-angiogenic therapy, is frequently prescribed to combat malignant neoplasms, irresectable melanomas and squamous cell carcinoma."

Answered by AI
~12 spots leftby Feb 2025