To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
University of Chicago
Chicago, Illinois, United States
Rhizen Pharmaceuticals investigational trial site; Karmanos Cancer Institute,
Detroit, Michigan, United States
University of Washington
Seattle, Washington, United States
Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment.
Time frame: 21 days
Maximum observed plasma concentration (Cmax)
Assessment of Cmax in subjects treated with RP6530 and pembrolizumab combination
Time frame: 21 days
Overall response rate (ORR) with Tenalisib and Pembrolizumab combination
No of patients with partial and complete response
Time frame: 12 weeks
Duration of Response (DoR) with Tenalisib and Pembrolizumab combination
The time period from the response achieved in patient until the disease progression.
Time frame: 12 weeks
Progression free survival (PFS) with Tenalisib and Pembrolizumab combination
Progression-free survival was defined as the time from enrollment in the study to disease progression
Time frame: 12 weeks
Conversion Rate with Tenalisib and Pembrolizumab combination
Defined as improved outcome status (i.e Improve from PR to CR or from SD to PR)
Time frame: 12 weeks
Proportion of patients achieving CR and PR with Tenalisib and Pembrolizumab combination
Time frame: 12 weeks
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