Expanded Access for Pembrolizumab (MK-3475)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03311542
• Date of registration: 12/10/2017
• Prospective Registration: Yes
• Primary sponsor: Center Trials & Treatment
• Public title: Expanded Access for Pembrolizumab (MK-3475)
• Scientific title: 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.
• Date of first enrolment: October 10, 2019
• Recruitment status: No longer available
• URL: https://clinicaltrials.gov/show/NCT03311542
• Study type: Expanded Access

Countries of recruitment

Belarus, Hong Kong, Tajikistan, Uzbekistan

Key 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Glioblastoma by Gene Expression Profile

Melanoma (Skin)

Melanoma Recurrent

Glioblastoma Multiforme

Glioma of Brain

Intervention(s)

Biological: pembrolizumab

Secondary ID(s)

PST-2-B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors