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Nivolumab for Mesothelioma

The University of Chicago, Chicago, IL
Mesothelioma+1 More ConditionsNivolumab - Drug
Eligibility
18+
All Sexes

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
  • Peritoneal Mesotheliomas
  • Mesothelioma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 42 Months

12 weeks
Peritoneal Carcinomatosis index (PCI) of Participants Who Taking Nivolumab Combined with Ipilimumab Before Surgery
Rate of Participants Who Report Serious Side Effects to Taking Nivolumab Combined with Ipilimumab After Surgery (Adjuvant Treatment)
19 weeks
Number of Participants Who Proceed to Surgery Without Delays After Receiving Nivolumab Combined with Ipilimumab
24 months
Major Pathologic (Disease) Response of Tumor to Nivolumab Combined with Ipilimumab Before Surgery
Radiologic response to nivolumab and ipilimumab before surgery
Week 3
Rate of Participants Who Report Serious Side Effects to Nivolumab Combined with Ipilimumab Before Surgery (Neoadjuvant Treatment)
42 Months
Overall Survival of Participants Who Take Nivolumab Combined with Ipilimumab Before Surgery
42 months
Progression-Free Survival of Participants Who Take Nivolumab Combined with Ipilimumab Before Surgery

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Side Effects for

Investigator Choice of Chemotherapy
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%Thrombocytopenia
15%Insomnia
14%Weight decreased
14%Hyponatraemia
14%Rash
14%Platelet count decreased
13%Blood creatinine increased
13%White blood cell count decreased
12%Pain in extremity
12%Pruritus
12%Hypokalaemia
12%Abdominal pain
11%Alanine aminotransferase increased
11%Aspartate aminotransferase increased
11%Myalgia
10%Pneumonia
10%Muscular weakness
10%Productive cough
10%Alopecia
10%Dry skin
10%Chest pain
10%Hypoalbuminaemia
10%Dysgeusia
9%Abdominal pain upper
9%Mucosal inflammation
9%Hypothyroidism
9%Upper respiratory tract infection
9%Peripheral sensory neuropathy
8%Lacrimation increased
8%Non-cardiac chest pain
8%Nasopharyngitis
8%Dysphonia
8%Epistaxis
8%Haemoptysis
8%Stomatitis
7%Anxiety
7%Bronchitis
7%Hypertension
7%Hyperkalaemia
7%Dehydration
7%Chills
7%Blood alkaline phosphatase increased
7%Hyperglycaemia
7%Lymphocyte count decreased
6%Oropharyngeal pain
6%Pneumonitis
6%Pleural effusion
6%Neuropathy peripheral
6%Hypophosphataemia
6%Leukopenia
5%Gamma-glutamyltransferase increased
5%Hypotension
5%Dry mouth
5%Muscle spasms
5%Pain
5%Urinary tract infection
5%Malaise
5%Depression
5%Rash maculo-papular
5%Dyspepsia
5%Musculoskeletal chest pain
4%Fall
4%Pulmonary embolism
3%Myocardial infarction
3%Metastases to central nervous system
3%Musculoskeletal pain
3%Chronic obstructive pulmonary disease
3%Febrile neutropenia
2%Adrenal insufficiency
2%Atrial fibrillation
2%Sepsis
2%Malignant pleural effusion
2%Embolism
2%Cardiac failure
2%General physical health deterioration
1%Pancytopenia
1%Lung cancer metastatic
1%Small intestinal haemorrhage
1%Neoplasm progression
1%Gastrointestinal haemorrhage
1%Colitis
1%Appendicitis
1%Respiratory tract infection
1%Bone pain
1%Ataxia
1%Syncope
1%Bronchial obstruction
1%Pneumothorax
1%Circulatory collapse
1%Superior vena cava syndrome
1%Respiratory failure
1%Seizure
1%Atrial flutter
1%Pericardial effusion
1%Ileus
1%Small intestinal obstruction
1%Performance status decreased
1%Skin infection
1%Femur fracture
1%Hypercalcaemia
1%Cancer pain
1%Pericardial effusion malignant
1%Confusional state
1%Tumour pain
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the Investigator Choice of Chemotherapy ARM group. Side effects include: Nausea with 57%, Anaemia with 54%, Fatigue with 51%, Decreased appetite with 39%, Malignant neoplasm progression with 36%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

All Participants in Study Who Have Mesothelioma
1 of 1

Experimental Treatment

2 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

All Participants in Study Who Have MesotheliomaExperimental Group · 2 Interventions: Nivolumab, Ipilimumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 42 months

Who is running the clinical trial?

University of ChicagoLead Sponsor
950 Previous Clinical Trials
759,545 Total Patients Enrolled
9 Trials studying Mesothelioma
1,252 Patients Enrolled for Mesothelioma
Kiran Turaga, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
417 Total Patients Enrolled
1 Trials studying Mesothelioma
24 Patients Enrolled for Mesothelioma

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of cancer called mesothelioma, and it can be treated with a surgery called cytoreduction and a procedure called hyperthermic intraperitoneal chemotherapy (HIPEC).
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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