Status:
TERMINATED
Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL
Lead Sponsor:
Rhizen Pharmaceuticals SA
Conditions:
Classical Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.
Eligibility Criteria
Inclusion
- Age ≥18 years on the day of signing informed consent.
- Histologically confirmed diagnosis of cHL.
- Disease status as defined as.
- Refractory patients who are naïve to anti-PD-1/PDL-1 therapy OR Relapsed after 3 or more lines of therapies; and are naïve to anti-PD-1/PDL-1 therapy OR
- Patients currently on Pembrolizumab and achieve a less than complete response
- Must have ECOG performance status of 0 or 1
- At least one bi-dimensional measurable lesion with minimum measurement of \> 15 mm in the longest diameter.
- Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia.
- Adequate bone marrows, liver and renal function as assessed by the following laboratory requirements. Hemoglobin ≥8.0 g/dL (may not be transfused or treated with erythropoietin in preceding week to maintain or exceed this level)
- Absolute neutrophil count (ANC) ≥1,000/µL
- Platelet count ≥75,000/μL
- Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
- ALT and AST ≤2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or CrCl \> 60 ml/min (Cockcroft-Gault formula)
- Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
- Provide written informed consent prior to any study-specific screening procedures.
- Willingness and capability to comply with the requirements of the study.
Exclusion
- Patient receiving anticancer therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1,
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Radiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ≥ 14 days prior to C1D1);
- Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D1.
- Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.
- Patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .
- Pregnancy or lactation.
- Known clinically active CNS involvement.
- Evidence of active Hepatitis B, active Hepatitis C infection (HCV) or cytomegalovirus (CMV) or known history of HIV.
- Subjects with concomitant second malignancies
- Patient with any active immune toxicity of Grade 1 or greater or any other severe or Grade 3 treatment-related adverse event.
- History of Grade 4 anaphylactic reaction to monoclonal antibody therapy.
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03471351
Start Date
July 18 2018
End Date
February 13 2019
Last Update
December 27 2019
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Rhizen Pharmaceuticals investigational trial site; Karmanos Cancer Institute,
Detroit, Michigan, United States, 48201
3
University of Washington
Seattle, Washington, United States, 98109