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Checkpoint Inhibitor

Nivolumab for Mesothelioma

Phase 2

Waitlist Available

Led By Kiran Turaga, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 months

Awards & highlights

Study Summary

This trial is for people with peritoneal mesothelioma. The doctors will give patients immunotherapy drugs before and after surgery to see if it decreases the amount of cancer cells and delays regrowth.

Eligible Conditions

Mesothelioma
Peritoneal Mesotheliomas

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major Pathologic (Disease) Response of Tumor to Nivolumab Combined With Ipilimumab Before Surgery

Secondary outcome measures

Number of Participants Who Proceed to Surgery Without Delays After Receiving Nivolumab Combined With Ipilimumab

Overall Survival of Participants Who Take Nivolumab Combined With Ipilimumab Before Surgery

Peritoneal Carcinomatosis Index (PCI) of Participants Who Taking Nivolumab Combined With Ipilimumab Before Surgery

+4 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%

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%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

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

Chills

Hypertension

Hyperkalaemia

Dehydration

Hyperglycaemia

Blood alkaline phosphatase increased

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Rash maculo-papular

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

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Confusional state

Pneumothorax

Atrial flutter

Femur fracture

Bone pain

Cancer pain

Neoplasm progression

Pericardial effusion malignant

Circulatory collapse

Hypercalcaemia

Bronchial obstruction

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: All Participants in Study Who Have MesotheliomaExperimental Treatment2 Interventions

Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. There will also be a follow up period to determine how well the drugs and surgery worked to get rid of your cancer. Your overall participation in this study (including drug treatment, surgery and follow up visits) will last for roughly one and a half years. All eligible participant who enroll in the study will participate in this group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,747 Total Patients Enrolled

9 Trials studying Mesothelioma

1,254 Patients Enrolled for Mesothelioma

Kiran Turaga, MDPrincipal InvestigatorUniversity of Chicago

4 Previous Clinical Trials

419 Total Patients Enrolled

1 Trials studying Mesothelioma

26 Patients Enrolled for Mesothelioma

Frequently Asked Questions

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

Is Nivolumab a secure and reliable treatment option for patients?

"The safety of Nivolumab has been rated at a 2 in Power's evaluation scale, indicating that while Phase 2 trials have yielded some evidence supporting its security, there is no available data regarding the drug's efficacy."

Answered by AI

Is this research endeavor still seeking participants?

"Clinicaltrials.gov states that the trial is currently seeking applicants, which were first requested on December 1st 2021 and was most recently adjusted on February 14th 2022."

Answered by AI

How many participants are involved in the current investigation?

"Confirmed. According to the clinicaltrials.gov data, this research study is still accepting applicants since its inception on December 1st 2021 and last update on February 14th 2022. 37 volunteers are being sought from a single center for participation in the trial."

Answered by AI

What medical issues has Nivolumab been prescribed to address?

"Nivolumab is typically used as a follow-up to anti-angiogenic therapy, but it has also been administered in cases of malignant neoplasms and unresectable melanoma or squamous cell carcinomas."

Answered by AI

Are there any existing records of Nivolumab's efficacy?

"Currently, 765 trials are in progress that research Nivolumab. Of these operational studies, 86 are Phase 3 clinical trials. The majority of the experiments conducted with this medication happen near Pittsburgh; however, there is an expansive network spanning across 42755 locations around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma

2021. "A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05041062.