Melanoma (Skin)NCT03311542
Expanded Access for Pembrolizumab (MK-3475)
A study testing pembrolizumab in people with Melanoma (Skin) and Melanoma Recurrent, run by Center Trials & Treatment at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma (Skin), Melanoma Recurrent, Glioblastoma Multiforme
- What is being tested?
- pembrolizumab
- How many people
- Not given
- Where
- 4 sitesin 4 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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 locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Tajikistan1 site
"Cancer Research Center" of the Ministry of Health of the Republic of Tajikistan
Dushanbe, 734026
Uzbekistan1 site
Republican Cancer Research Center of the Ministry of Health of the Republic of Uzbekistan (RENTC MH RUz)
Tashkent, 100049
About this study
Official 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.
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.
Read the 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
- Being tested
- pembrolizumab
- Keywords
- GBM, Glioma
- Medical subject headings
- Melanoma, Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumabBiological
Also called MK-3475
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
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Center Trials & Treatment
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311542
- Sponsor's protocol ID
- PST-2-B
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
Publications
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.
PubMed 26848796Buiar 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.
PubMed 28573105Preusser 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.
PubMed 26260659
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT03311542
- Acronym / sponsor ID
- PST-2-B
- Conditions
- Melanoma (Skin), Melanoma Recurrent, Glioblastoma Multiforme, Glioblastoma by Gene Expression Profile, Glioma of Brain
- Keywords
- GBM, Glioma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Center Trials & TreatmentUniversity, hospital or other
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumabAlso: MK-3475Each 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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Background: PubMed 26848796Kottschade 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.
- Background: PubMed 28573105Buiar 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.
- Background: PubMed 26260659Preusser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pembrolizumab in people with Melanoma (Skin) and Melanoma Recurrent, run by Center Trials & Treatment at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belarus, Hong Kong, Tajikistan, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311542, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.