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Expanded Access for Pembrolizumab (MK-3475)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03311542
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Center Trials & Treatment
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status No longer available
Countries Belarus, Hong Kong, Tajikistan, Uzbekistan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma (Skin), Melanoma Recurrent, Glioblastoma Multiforme, Glioblastoma by Gene Expression Profile, Glioma of Brain
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

N.N. Alexandrov National Cancer Centre, Minsk, Belarus

Status

Address

N.N. Alexandrov National Cancer Centre

Minsk, , 223040

The Hong Kong Cancer Institute, Hong Kong, Hong Kong

Status

Address

The Hong Kong Cancer Institute

Hong Kong, , 518031

Dushanbe, Tajikistan

Status

Address

"Cancer Research Center" of the Ministry of Health of the Republic of Tajikistan

Dushanbe, , 734026

Tashkent, Uzbekistan

Status

Address

Republican Cancer Research Center of the Ministry of Health of the Republic of Uzbekistan (RENTC MH RUz)

Tashkent, , 100049