Trials / No Longer Available
No Longer AvailableNCT03311542
Expanded Access for Pembrolizumab (MK-3475)
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.
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Center Trials & Treatment · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- —
Summary
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.
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.
Conditions
- Melanoma (Skin)
- Melanoma Recurrent
- Glioblastoma Multiforme
- Glioblastoma by Gene Expression Profile
- Glioma of Brain
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pembrolizumab | Each participant will receive pembrolizumab every 21 days for up to 12 month or until confirmed disease progression on MRI or CT, unacceptable toxicity, confirmed.positive pregnancy test or withdrawal of consent. |
Timeline
- First posted
- 2017-10-17
- Last updated
- 2018-01-10
Locations
4 sites across 4 countries: Belarus, Hong Kong, Tajikistan, Uzbekistan
Source: ClinicalTrials.gov record NCT03311542. Inclusion in this directory is not an endorsement.