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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

Must not have

Evidence of active or acute diverticulitis, intra-abdominal abscess, abdominal/pelvic fistula, gastrointestinal perforation, gastrointestinal (GI) obstruction and/or requirement for parenteral hydration and/or nutrition

Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have current severe digestive system problems.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I have previously been treated with specific immune-targeting cancer drugs.

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I have brain metastases that don't meet certain conditions.

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I am a woman able to have children and I agree to use birth control.

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I have an autoimmune disease that affects my organs or needs strong medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Overall Survival

Progression-free Survival

Other study objectives

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 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

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%

Tinnitus

10%

Cushingoid

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5220

0 / 17Eligibility criteria met