- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03311542
Expanded Access for Pembrolizumab (MK-3475)
9. januar 2018 opdateret af: 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.
Studieoversigt
Status
Ikke længere tilgængelig
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Udvidet adgang
Udvidet adgangstype
- Individuelle patienter
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hong Kong, Hong Kong, 518031
- The Hong Kong Cancer Institute
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Minsk, Hviderusland, 223040
- N.N. Alexandrov National Cancer Centre
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Dushanbe, Tadsjikistan, 734026
- "Cancer Research Center" of the Ministry of Health of the Republic of Tajikistan
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Tashkent, Usbekistan, 100049
- Republican Cancer Research Center of the Ministry of Health of the Republic of Uzbekistan (RENTC MH RUz)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Preusser M, Lim M, Hafler DA, Reardon DA, Sampson JH. Prospects of immune checkpoint modulators in the treatment of glioblastoma. Nat Rev Neurol. 2015 Sep;11(9):504-14. doi: 10.1038/nrneurol.2015.139. Epub 2015 Aug 11.
- Kottschade LA, McWilliams RR, Markovic SN, Block MS, Villasboas Bisneto J, Pham AQ, Esplin BL, Dronca RS. The use of pembrolizumab for the treatment of metastatic uveal melanoma. Melanoma Res. 2016 Jun;26(3):300-3. doi: 10.1097/CMR.0000000000000242.
- Buiar PG, de Azevedo SJ. Atypical Presentation: Metastatic Uveal Melanoma in a Young Patient without Visual Complaints. Front Oncol. 2017 May 18;7:99. doi: 10.3389/fonc.2017.00099. eCollection 2017.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
12. oktober 2017
Først indsendt, der opfyldte QC-kriterier
12. oktober 2017
Først opslået (Faktiske)
17. oktober 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Astrocytom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Glioblastom
- Gliom
- Melanom
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Pembrolizumab
Andre undersøgelses-id-numre
- PST-2-B
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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