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Checkpoint Inhibitor
Nivolumab for Advanced Cervical Cancer
Phase 2
Waitlist Available
Led By Alessandro D Santin
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
Any other prior therapy directed at the malignant tumor including chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least three weeks prior to registration
Investigation agents must be discontinued for at least 30 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing nivolumab to treat patients with cervical cancer that has returned or spread. Nivolumab is a monoclonal antibody that may help to block tumor growth.
Who is the study for?
This trial is for patients with persistent, recurrent, or metastatic cervical cancer. Participants must have completed prior treatments and recovered from their effects, have measurable disease as per RECIST 1.1 criteria, and a performance status of 0 or 1. They should not be pregnant or nursing and agree to use contraception. Exclusions include brain metastases under certain conditions, HIV/AIDS, active hepatitis infection, autoimmune diseases requiring treatment, previous nivolumab therapy or similar drugs targeting immune pathways.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Nivolumab—a monoclonal antibody—in treating cervical cancer that has grown back or spread. It aims to see how well it works by blocking tumor growth in different ways by targeting specific cells.See study design
What are the potential side effects?
Nivolumab may cause side effects such as fatigue; reactions at the injection site; allergic reactions; issues affecting organs like liver or lungs due to inflammation; endocrine problems like thyroid dysfunction; skin rash and other immune-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I stopped any cancer treatments at least 3 weeks ago.
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I haven't taken any experimental drugs in the last 30 days.
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I finished any radiation therapy at least 4 weeks ago.
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It has been over 4 weeks since my last major surgery.
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I have a tumor or lymph node that meets the size requirements for measurement.
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I have had one chemotherapy treatment for my cervical cancer that has come back or spread.
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My cervical cancer has returned or spread and is getting worse.
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I stopped my previous cancer treatment at least 3 weeks ago.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is not classified as minimal deviation, gastric type, clear cell, or mesonephric carcinoma.
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
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by CTCAE Version 4
Objective Tumor Response as Assessed by RECIST 1.1 Criteria
Secondary outcome measures
Overall Survival
Progression-free Survival
Other outcome measures
Change in the CTC Count
Change in the Immune Response to HPV 16/18/31/35/45 E7 Antigen in Peripheral Blood Lymphocytes and Serum
Immune Infiltration Related Biomarkers (i.e., CD4+, CD8+, FoxP3) in Tumor Specimens
+1 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%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
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%
Alopecia
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
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%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
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%
Pericardial effusion malignant
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
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
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab)Experimental Treatment2 Interventions
Patients receive nivolumab IV over approximately 60 minutes every 2 weeks for a maximum of 46 doses over 92 weeks 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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,337 Total Patients Enrolled
NRG OncologyOTHER
232 Previous Clinical Trials
100,752 Total Patients Enrolled
Alessandro D SantinPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
11 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have had a scan of the specific area being treated within the past 28 days before enrolling in the trial.I stopped any cancer treatments at least 3 weeks ago.I haven't taken any experimental drugs in the last 30 days.It has been over 4 weeks since I had any major surgery.I do not have current severe digestive system problems.I finished my radiation therapy at least 4 weeks ago.I finished any radiation therapy at least 4 weeks ago.It has been over 4 weeks since my last major surgery.I have recovered from the side effects of my recent cancer treatment.My cervical cancer has spread or returned and cannot be cured with surgery or radiation.I have a tumor or lymph node that meets the size requirements for measurement.I have previously been treated with specific immune-targeting cancer drugs.I have at least one measurable tumor that hasn't been treated with radiation, or if it has, it's still growing.I have had one chemotherapy treatment for my cervical cancer that has come back or spread.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.My cervical cancer has returned or spread and is getting worse.I stopped my previous cancer treatment at least 3 weeks ago.You are currently pregnant or breastfeeding.You had a physical exam within 28 days before signing up for the study.My kidney function, measured by creatinine levels or clearance, is within the required range.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastases that don't meet certain conditions.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.My cancer is not classified as minimal deviation, gastric type, clear cell, or mesonephric carcinoma.I am a woman able to have children and I agree to use birth control.I have an autoimmune disease that affects my organs or needs strong medication.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab)
Awards:
This trial has 1 awards, including:- 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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