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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 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.

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

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 more

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%

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

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Dehydration

Hyperkalaemia

Hyperglycaemia

Chills

Blood alkaline phosphatase increased

Hypertension

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Femur fracture

Bone pain

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Neoplasm progression

Circulatory collapse

Atrial flutter

Bronchial obstruction

Hypercalcaemia

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,127 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,826 Total Patients Enrolled

Alessandro D SantinPrincipal InvestigatorNRG Oncology

1 Previous Clinical Trials

11 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02257528 — Phase 2

Cervical Cancer Research Study Groups: Treatment (nivolumab)

Cervical Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02257528 — Phase 2

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02257528 — Phase 2

Frequently Asked Questions

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

At how many different sites is this trial being conducted?

"Currently, this trial is taking place in 100 different clinics. While the primary locations are El Dorado, Coeur d'Alene and Pekin, there are also satellite sites in other cities. If you enroll in this study, it is best to choose a location near you to avoid excessive travelling."

Answered by AI

Are there other ongoing studies that are testing Nivolumab?

"There are currently 747 studies being conducted that involve the use of Nivolumab. Out of those, 82 are in Phase 3. Though most trials for this treatment originate from Basel, BE, there are a total of 40325 locations running these sorts of tests."

Answered by AI

For what maladies is Nivolumab most frequently recommended?

"Nivolumab is often used to treat malignant neoplasms, but can also help patients with metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."

Answered by AI

Are investigators still looking for participants for this clinical trial?

"This particular clinical trial, which was initial posted on May 18th 2015 and last updated September 23rd 2022 according to clinicaltrials.gov, is not currently recruiting patients. That said, there are 4,417 other trials that are actively looking for participants."

Answered by AI

Is this a new clinical trial?

"Nivolumab has had 747 clinical trials since the first one in 2010. The initial study, sponsored by Medarex, involved 127 patients and completed its Phase 1 drug approval stage. So far, 806 studies have been conducted across 2347 cities in 50 different countries."

Answered by AI

How many people fit the inclusion criteria for this clinical trial?

"This clinical trial is no longer seeking participants. It was originally posted on 5/18/2015 and last updated on 9/23/2022. However, there are currently 3670 studies actively recruiting patients with stage iv cervical cancer ajcc v6 and v7, and 747 studies for Nivolumab that are actively recruiting patients."

Answered by AI