Expanded Access for Pembrolizumab (MK-3475)

January 9, 2018 updated by: Center Trials & Treatment

Expanded Access for Pembrolizumab (MK-3475) to Patients With Melanoma or Glioblastoma / Glioma After Failed Standart Therapy, at High Mutational Load Which is Confirmed by the Results of Molecular-genetic Analysis of Tumor Tissue.

This is an expanded access program (EAP) for patient with Melanoma and Glioblastoma who have progressed after prior Protocol therapy including Bevacizumab, Temozolomide ( TMZ ), Ipilimumab, BRAF and MEK inhibitors. The patients whose tumors are EGFR, MET or ALK positive should first receive an EFGR or ALK inhibitor, respectively, prior to treatment with pembrolizumab.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Pembrolizumab has been approved by the U.S. Food and Drug Administration for the treatment of patients with Glioblastoma and Melanoma The Expanded Access Program (EAP) for this medicine in the U.S. is closed. The EAP will continue outside the U.S.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 223040
        • N.N. Alexandrov National Cancer Centre
  • Hong Kong
      • Hong Kong, Hong Kong, 518031
        • The Hong Kong Cancer Institute
  • Tajikistan
      • Dushanbe, Tajikistan, 734026
        • "Cancer Research Center" of the Ministry of Health of the Republic of Tajikistan
  • Uzbekistan
      • Tashkent, Uzbekistan, 100049
        • Republican Cancer Research Center of the Ministry of Health of the Republic of Uzbekistan (RENTC MH RUz)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient's willing to sign Informed Consent.
  • Unresectable metastatic Melanoma / Glioblastoma / Glioma.
  • Failed or progressed on standard of care systemic therapy including bevacizumab, ipilimumab, radiotherapy, regardless of prior treatment with a BRAF/ MEK/ EGFR/ MET/ ALK inhibitors, as long as all other eligibility criteria for this study are met.
  • Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity starting with the first dose of treatment through at least 120 days after the last dose of pembrolizumab.
  • Male participants must agree to use an adequate method of contraception starting with the first dose of treatment through 120 days after the last dose of pembrolizumab.
  • Results of partial genomic or full-genomic sequencing or genetic studies to determine the status of the patient's mutation load.
  • ECOG performance status greater than or equal to 2
  • Adequate kidney function: serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance greater than or equal to 40 mL/min
  • Adequate bone marrow function: absolute neutrophil count greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L
  • Adequate liver function: total bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase less than or equal to 3 x ULN (or less than or equal to 5 x ULN in case of liver metastases). If alkaline phosphatase is greater than 3 x ULN (in absence of liver metastases) or greater than 5 x ULN (in presence of liver metastases) AND patient also is known to have bone metastases, the liver specific alkaline phosphatase must be used to assess liver function instead of total alkaline phosphatase
  • Willing and able to comply with all aspects of the treatment protocol

Exclusion Criteria:

  • Eligibility for any other pembrolizumab study open in the same region.
  • Existing anti-cancer therapy-related toxicities of grade 2 or more, except that alopecia and grade 2 neuropathy are acceptable.
  • History of congestive heart failure with New York Heart Association Classification greater than grade II, unstable angina, myocardial infarction within the past 6 months or serious cardiac arrhythmia.
  • Electrocardiogram with QTc interval of greater than or equal to 500 msec based upon Bazett's formula (QTcB).
  • The Investigator believes the patient to be medically unfit to receive pembrolizumab or unsuitable for any other reason.
  • Pregnancy (positive B-hCG test) or breastfeeding.
  • Hypersensitivity to pembrolizumab.
  • Use of corticosteroids for this indication has been discontinued for at least 4 weeks before starting treatment in this protocol.
  • History of or concomitant medical condition that, in the opinion of the Investigator, would compromise the patient's ability to safely complete the treatment protocol.
  • Meningeal carcinomatosis.
  • Pulmonary lymphangitic involvement resulting in pulmonary dysfunction requiring active treatment, including use of oxygen.
  • Not recovered from minor or major surgery and less than 4 weeks from major surgery
  • History of life-threatening or severe immune-related adverse events on treatment with another immunotherapy.
  • Expected to require any other form of systemic antineoplastic therapy while receiving pembrolizumab.
  • History of clinically severe autoimmune disease (e.g., requires chronic immunosuppressive therapy).
  • History of pneumonitis, organ transplant, human immunodeficiency virus (HIV), active hepatitis B or hepatitis C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Trials & Treatment

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PST-2-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Clinical Trials on pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe