Study of Tremelimumab in Patients With Advanced Solid Tumors (NCT02527434) | Clinical Trial Compass
CompletedPhase 2
Study of Tremelimumab in Patients With Advanced Solid Tumors
United States, Belgium64 participantsStarted 2015-11-02
Plain-language summary
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors
Who can participate
Age range18 Years – 150 Years
SexALL
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Inclusion Criteria:
1\. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.
Exclusion criteria:
1\. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient
What they're measuring
1
Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase
Timeframe: From baseline to 12 months in the tremelimumab monotherapy phase