On www.ClinicalTrials.gov there are 3 listings involving mesothelioma and Pembrolizumab.
The first clinical trial listed is for malignant mesothelioma patients only.
We will be featuring this trial below. This is the only mesothelioma-exclusive clinical trial listed.
The second trial is not yet recruiting. It will include other cancers as well. The title is: A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients.
The third trial is ongoing and recruiting, it involves other cancers besides mesothelioma, is at multiple sites, and for people whose cancers have progressed on standard therapy. It is titled: Study of Pembrolizumab (MK-3475) in Participants with Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
Clinical Trial- NCT02399371
Pembrolizumab in Treating Patients With Malignant Mesothelioma
Official Title: A Phase II Study of the Anti-PD-1 Antibody Pembrolizumab in Patients with Malignant Mesothelioma
Listing on www.clinicaltrials.gov
Sponsor- University of Chicago
Principal Investigator- Hedy L Kindler M.D.
Contact: Hedy L. Kindler 773-702-0360 hkindler@medicine.bsd.uchicago.edu
Number of Participants- 65
Purpose:
This clinical trial is for patients with malignant mesothelioma. It is for both peritoneal and pleural mesothelioma, and for cell types, (epithelioid, biphasic , sarcomatoid) the most common ones. It also includes recurrent peritoneal and pleural mesothelioma. It is a Phase II trial. The drug Pembrolizumab is a monoclonal antibody. The way monoclonal antibodies work is by blocking a protein called programmed cell death 1 (PD-1) which may stimulate an immune response and kill tumor cells.
Screening:
Pemnrolizumab focuses on a protein called PD-L1 which is expressed by mesothelioma types of tumors. You must have enough tissue for diagnosis so 3 biomarkers can be studied. You must have an archived specimen of your tumor or you will need to have a biopsy . Your disease must be measurable. A recent CT scan could have the information required. You must have had chemotherapy and either finished treatment or were unable to tolerate chemotherapy. Your tumor specimen will be submitted to Merck and will be tested for the bio-markers. This process takes approximately 3-4 weeks.
Eligibility Criteria
Age 18 or older, male or female, histologically or cytologically confirmed pleural or peritoneal malignant mesothelioma, epithelial, sarcomatoid, or biphasic subtypes. Only for part B-PD-L1 selection should a PD-L1expression threshold have been defined in Part A and potentially additional mesothelioma trial data; there will be no PD-L1/biomarker selection for Part A, no more than 2 prior lines of cytoxic therapy, which should have included pemetrexed and a platinum. Enrollment of treatment naïve patients who refuse standard chemotherapy or are intolerant may be permissible if reviewed and deemed clinically appropriate by the principal investigator.
Disease progression on or after pemetrexed and cisplatin or carboplatin (These are the first ones listed there are more- check on www.clinicaltrials.org ).
Exclusions:
Patients who are currently participating in or have participated in a study of investigational agent or have used an investigational device within 2 weeks (4 weeks for monoclonal antibodies) of the first dose of treatment. Also, patients that: have had side effects from prior treatment which have not resolved to =
How the Research Study is Designed to Work:
Pembrolizumab is infused through an I.V. over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab.
As with any clinical trial you are free to withdraw at any point during the process.
