Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
21 participants
INTERVENTIONAL
2019-03-07
2024-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tinostamustine and Nivolumab
Experimental drug combination arm
Tinostamustine
First-in-human administration of the combination of Tinostamustine and Nivolumab.
Interventions
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Tinostamustine
First-in-human administration of the combination of Tinostamustine and Nivolumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with either histologically or cytologically confirmed inoperable stage III or metastatic stage IV melanoma
* Indication for the regular systemic treatment with the anti-PD-1 monoclonal antibody Nivolumab monotherapy
* Patient received a maximum of 1 prior systemic palliative line of treatment
* ECOG ≤2
* Patients with brain metastases must have undergone definitive treatment (surgery or radiotherapy) at least 2 weeks prior to starting study drug and be documented as having stable disease by imaging
* Adequate bone marrow, renal and hepatic function
* Adequate contraception
Exclusion Criteria
* Patients who have received systemic treatments or radiotherapy within 2 weeks prior to starting study drug
* Concomittant treatment with systemic steroids at a daily dose equivalent to ≥10mg of prednisone, or concomittant treatment with immunosuppressive drugs such as methotrexate
* Patients with a prior malignancy are excluded (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, colon,cervical/dysplasia, melanoma, or breast). Patients with other second malignancies diagnosed more than 2 years ago who have received therapy with curative intent with no evidence of disease during the interval who are considered by the Investigator to present a low risk for recurrence will be eligible.
* NYHA stage III/IV congestive heart failure and/or arrhythmia not adequately controlled
* QTc interval (Fridericia's formula) \> 450msec
* Patients who are on treatment with drugs known to prolong the QT/QTc interval (Credible Meds list:
Known risk of TdP. https://www.crediblemeds.org).
* Pregnant and breast feeding patients
18 Years
ALL
No
Sponsors
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Markus Joerger
OTHER
Responsible Party
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Markus Joerger
Chair Clinical Research Unit
Principal Investigators
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Markus Joerger, Prof.
Role: STUDY_CHAIR
Cantonal Hospital St. Gallen, Switzerland
Locations
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Kantonsspital Graubünden
Chur, , Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Clinical Trials Unit St. Gallen, Switzerland
Other Identifiers
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CTU 17.022
Identifier Type: -
Identifier Source: org_study_id
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