CLINICAL TRIAL

Pembrolizumab for Mesothelioma

Waitlist Available · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether a combination of chemotherapy and a drug called pembrolizumab may help treat malignant pleural mesothelioma.

See full description

About the trial for Mesothelioma

Eligible Conditions
Pleural Mesotheliomas · Mesothelioma, Malignant · Mesothelioma

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab 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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pemetrexed
DRUG
Pembrolizumab
DRUG
Indocyanine Green (ICG) Image-Guided Surgery
PROCEDURE
Cisplatin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Pembrolizumab
FDA approved
Cisplatin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subjects are required to provide a tissue sample from a newly obtained core or excisional biopsy of a tumor lesion show original
If your organ function is adequate, all screening labs should be performed within 10 days of starting treatment. show original
Female subjects who could potentially become pregnant must be willing to use an effective method of contraception for the entire study period, which is 120 days after the final dose of the study medication show original
Male subjects who could potentially father a child must agree to use contraception starting with the first dose of the study drug and continuing through 120 days after the last dose of the study drug show original
The individual has a performance status of 0 or 1 on the ECOG Performance Scale. show original
The participant must be willing and able to provide written informed consent for the trial. show original
You must be 18 years of age or older on the day you sign the informed consent form. show original
Have a measurable disease based on RECIST 1.1. show original
Women who could potentially become pregnant should have a negative urine or serum pregnancy test within 72 hours before receiving the first dose of the study medication show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Each subject will be assessed for OS from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)
Screening: ~3 weeks
Treatment: Varies
Reporting: Each subject will be assessed for OS from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Each subject will be assessed for OS from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 2 secondary outcomes in patients with Mesothelioma. Measurement will happen over the course of Each subjects will be assessed for AEs from the time of their first study treatment until 30 days after the end of their treatment for AEs and until 90 days after their last treatment for serious AEs (study treatment may last for up to 1 year).

Study related adverse events (AEs)
EACH SUBJECTS WILL BE ASSESSED FOR AES FROM THE TIME OF THEIR FIRST STUDY TREATMENT UNTIL 30 DAYS AFTER THE END OF THEIR TREATMENT FOR AES AND UNTIL 90 DAYS AFTER THEIR LAST TREATMENT FOR SERIOUS AES (STUDY TREATMENT MAY LAST FOR UP TO 1 YEAR)
Study related adverse events (AEs)
EACH SUBJECTS WILL BE ASSESSED FOR AES FROM THE TIME OF THEIR FIRST STUDY TREATMENT UNTIL 30 DAYS AFTER THE END OF THEIR TREATMENT FOR AES AND UNTIL 90 DAYS AFTER THEIR LAST TREATMENT FOR SERIOUS AES (STUDY TREATMENT MAY LAST FOR UP TO 1 YEAR)
Progression-free survival (PFS)
EACH SUBJECT WILL BE ASSESSED FOR PFS FROM THE TIME OF THEIR FIRST STUDY TREATMENT UNTIL THE DATE WHEN THEY HAVE DOCUMENTED DISEASE PROGRESSION OR DEATH (WHICHEVER COMES FIRST), OR UNTIL THE STUDY IS COMPLETED (ESTIMATED 2 YEARS FOR STUDY COMPLETION)
Progression-free survival (PFS)
EACH SUBJECT WILL BE ASSESSED FOR PFS FROM THE TIME OF THEIR FIRST STUDY TREATMENT UNTIL THE DATE WHEN THEY HAVE DOCUMENTED DISEASE PROGRESSION OR DEATH (WHICHEVER COMES FIRST), OR UNTIL THE STUDY IS COMPLETED (ESTIMATED 2 YEARS FOR STUDY COMPLETION)
Overall survival (OS)
EACH SUBJECT WILL BE ASSESSED FOR OS FROM THE TIME OF THEIR FIRST STUDY TREATMENT UNTIL THE DATE WHEN THEY HAVE DOCUMENTED DISEASE PROGRESSION OR DEATH (WHICHEVER COMES FIRST), OR UNTIL THE STUDY IS COMPLETED (ESTIMATED 2 YEARS FOR STUDY COMPLETION)
Overall survival (OS)
EACH SUBJECT WILL BE ASSESSED FOR OS FROM THE TIME OF THEIR FIRST STUDY TREATMENT UNTIL THE DATE WHEN THEY HAVE DOCUMENTED DISEASE PROGRESSION OR DEATH (WHICHEVER COMES FIRST), OR UNTIL THE STUDY IS COMPLETED (ESTIMATED 2 YEARS FOR STUDY COMPLETION)

Patient Q & A Section

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

What is mesothelioma?

Mesothelioma is an unusual and highly malignant cancer affecting the serous membranes, arising from the parietal pericardium, which surrounds the heart and lungs. It usually occurs around the age of 50 and is more common in women. It is treated by surgical removal and chemotherapy. Survival is less than 10% after a few years.

Anonymous Patient Answer

What are common treatments for mesothelioma?

As mesothelioma is largely diagnosed postoperatively, the treatments are mostly palliative. Most mesothelioma patients are treated with surgery if the tumor is small, and chemotherapy or radiation therapy if the tumor is more advanced. Mesothelioma tends to remain a fatal cancer with a six-month survival rate of approximately 20%.\n

Anonymous Patient Answer

What are the signs of mesothelioma?

The major signs of mesothelioma and its precursor, pleural malignancy are coughing up blood, chest pain, dyspnea and coughing up blood with blood. However, the symptoms of mesothelioma vary greatly. Tumor size, location and metastatic spread can also play a role in determining the specific signs and symptoms of the cancer.

Anonymous Patient Answer

What is the survival rate for mesothelioma?

Survival time for mesothelioma patient is mostly found to be correlated with both the stage at diagnosis and the patient's age; stage 5s, however, show the longest survival.

Anonymous Patient Answer

Is pembrolizumab safe for people?

This pooled analysis of clinical trials show that pembrolizumab has the potential to be an effective and safe treatment for patients with advanced MPM. These data should help guide treatment decisions for patients with MPM who have undergone prior systemic therapy and will aid in developing new treatments for this disease once new agents and targeted therapies become available.

Anonymous Patient Answer

What causes mesothelioma?

Both radiation and asbestos exposure are risk factors for mesothelioma. Other potentially implicated agents include many drugs, some of which have also been used in therapy for cancer, and environmental chemicals such as asbestos. Mesothelioma is a disease that develops in a very diverse group of patients, and most physicians have never seen a case. More importantly, many people are unaware of their own elevated risk of developing this disease. Mesothelioma has a high mortality rate, and is often diagnosed too late to produce a cure.

Anonymous Patient Answer

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

While the number of new cases occurring in the US is expected to be higher than those in Europe, an equivalent number of people will develop this malignancy and it is not clear whether the disease burden will become greater in the US or not. The difference in survival between whites and blacks cannot be explained by increased incidence of the malignancy among whites. It would be more informative to determine the cause of these differences and their relation to racial disparities in treatment or survival.

Anonymous Patient Answer

Can mesothelioma be cured?

Most patients with mesothelioma are cured by surgery or chemotherapy. While surgical options are most frequently curative at early stages of disease, chemotherapy can prolong survival in most patients with resectable and advanced disease.

Anonymous Patient Answer

What are the latest developments in pembrolizumab for therapeutic use?

The use of pembrolizumab for treatment of advanced mesothelioma appears to be safe and results in significant improvement in survival. Further research is needed to explore the therapeutic benefit of pembrolizumab for treatment of malignant pleural mesothelioma.

Anonymous Patient Answer

How quickly does mesothelioma spread?

The rate of dissemination and survival may be influenced by a number of factors, such as patient, tumor histological and histological grade type, tumor stage, and the ability of the tumor microenvironment to support proliferation and metastatic dissemination. The presence of occult disease in an early Tumor stage (Stage I or II) will increase the likelihood of spread, and the ability of tumors to metastasize must be considered when making patient treatment programs, which require adequate patient selection to optimize outcomes after surgery.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Mesothelioma by sharing your contact details with the study coordinator.