Ipilimumab for Mesothelioma

Phase-Based Estimates
2
Effectiveness
3
Safety
Centro di Riferimento Oncologico, Aviano, Italy
Mesothelioma+1 More
Ipilimumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Mesothelioma

Study Summary

This study is evaluating whether a combination of two drugs can be more effective than one drug alone.

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Eligible Conditions

  • Mesothelioma
  • Mesothelioma, Malignant

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Ipilimumab will improve 1 primary outcome and 6 secondary outcomes in patients with Mesothelioma. Measurement will happen over the course of From randomization to the date of death (Up to 40 Months).

Month 40
Overall Survival (OS)
Up to 40 months
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Objective Response Rate (ORR) According to PD-L1 Expression Level
Overall Survival (OS) According to PD-L1 Expression Level
Progression Free Survival (PFS)
Progression Free Survival (PFS) According to PD-L1 Expression Level

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Pemetrexed and Cisplatin (or Carboplatin)
Nivolumab and Ipilimumab

This trial requires 605 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ipilimumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Nivolumab and IpilimumabSpecified dose on specified days
Pemetrexed and Cisplatin (or Carboplatin)Specified dose on specified days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 40 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 40 months for reporting.

Closest Location

University Of Chicago - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We have a tumor sample that is available for testing show original
results A person's blood work results are acceptable if they fall within the normal range show original
To learn more about how to participate in a Bristol-Myers Squibb clinical trial, please visit www.BMSStudyConnect.com show original
People who are at least 18 years of age are allowed to vote. show original
This means that the person has a tumor on the pleural membrane lining the lungs, but surgery cannot cure it. show original
The patient has a performance status of 0 or 1. show original

Patient Q&A Section

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

Has ipilimumab proven to be more effective than a placebo?

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Ipilimumab-based therapy provided no significant difference to placebo in delaying disease progression among participants not previously treated with chemotherapy or immunotherapy. The clinical benefit of ipilimumab deserves further testing.

Unverified Answer

What are the signs of mesothelioma?

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Most patients with mesothelioma have no specific signs or symptoms of the disease. Symptoms are largely attributed to the associated lung disease. Symptoms associated with pleural effusion alone, without signs of the underlying cancer, are often attributed to heart failure or other lung diseases; these include shortness of breath, cough, weight loss, or coughing up blood.

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What is mesothelioma?

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Mesothelioma occurs most commonly in persons between the ages of 40 and 50, more often in women than men, in an occupational setting, in persons who have a family history of cancer and also in the presence of the genetic condition, hereditary non-polyposis colorectal cancer. It presents clinically as a tumour in the abdomen or pelvis, painless, diffuse swelling and the presence of pain and/or a mass. Mesotheliomas are diagnosed by biopsy or by operative examination and histology. Although the average survival from the initial diagnosis of mesothelioma is 3 to 5 years, the average survival in these patients with recurrent disease is only 3 to 6 months.

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What causes mesothelioma?

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The cause of mesothelioma remains unknown. The disease is believed to be preceded at least in a significant proportion of cases by asbestos exposure or heavy exposure to second-hand tobacco smoke. The most plausible explanation is that asbestos and asbestos-like fibers are a natural part of the environment. Although asbestos is considered a carcinogen, no conclusive proof of a carcinogenic effect has been found. The incidence of mesothelioma has increased in industrialized countries in parallel with an increase in occupational exposure to asbestos. Although asbestos exposure is generally accepted as being a significant contributor to the development of mesothelioma it is not believed by physicians to be solely responsible for the disease.

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Can mesothelioma be cured?

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Mesothelioma cannot be completely eradicated. However, there is evidence that a high dosage of cytotoxic therapy may be of use in the adjuvant treatment of the disease\n

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What are common treatments for mesothelioma?

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Mesothelioma is treated almost exclusively by chemotherapy with cytotoxic drugs, including mitomycin C, vinblastine, bleomycin, cisplatin, etoposide, paclitaxel, nimotuzumab, docetaxel and pemetrexed. In addition, immunotherapy has been used with some success. However, given the limitations of all chemotherapeutic agents, radiotherapy and other modalities are necessary and appropriate for most patients.

Unverified Answer

How many people get mesothelioma a year in the United States?

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The most recent report from the SEER database lists 5,880 cases of mesothelioma in the United States for 1999. We were unable to find any other published information on this problem. We conclude that mesothelioma is a condition for which the number of cases in the United States cannot be estimated very well.

Unverified Answer

What are the chances of developing mesothelioma?

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mesothelioma can be controlled. There is much that we don't know about a risk factor for mesothelioma but for the time being people just need to make regular visits to their doctors and take prescribed drugs to control the symptoms of mesothelioma. When this disease becomes a debilitating illness, some sufferers will wish that they could have it under control. The chances for people to have their mesothelioma diagnosed is also decreased if they develop the underlying causes of this disease and the signs and symptoms are related to this condition. This article also explains the differences between benign and malignant mesothelioma.

Unverified Answer

Have there been any new discoveries for treating mesothelioma?

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Mesothelioma is a disease that most commonly develops after exposure to Asbestos. Treatment for mesothelioma includes surgery, radiation, and chemotherapy drugs. The most common form of treatment is surgery where only part of the tumor is removed. Radiation is also used for some types of mesothelioma but usually has a less successful result than surgery. One type of chemotherapy, which is used is a treatment that involves removing the cancerous cells that are inside a patient's body. The process of chemotherapy to treat this type of cancer is known as the "debulking" or "plegeting" process.

Unverified Answer

How quickly does mesothelioma spread?

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The time from the first symptoms to diagnosis varies enormously between patients. Many patients develop symptoms more than 20 years after exposure to asbestos. The average time from first symptoms to the onset of pleural mesothelioma diagnosed was 26.4 years. Patients diagnosed with malignant pleural mesothelioma were diagnosed 6.6 years earlier (p < .001) than for those with malignant pericardial mesothelioma; for patients diagnosed with peritoneal mesothelioma, the average delay was 13.2 years and 24.3 years were spent with the disease before the patient developed signs of the disease (p < .001) [Fig.6].

Unverified Answer

Does mesothelioma run in families?

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The family history of lung cancer supports an etiological role for a familial predisposition to lung cancer. We could not demonstrated a significant association of mesothelioma with a positive family history. The occurrence of pleural mesothelioma in two related individuals suggests a genetic predisposition, but such evidence is still inconclusive.

Unverified Answer

How serious can mesothelioma be?

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There were some commonalities between the data. In the USA, it is more difficult to screen women than men for asbestos exposure. In Italy both sexes are screened equally often. In Germany, it is more difficult to screen men than women for asbestos exposure. Mesothelioma patients have a much higher mortality than patients with pleural cancer

Unverified Answer
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