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Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL

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ClinicalTrials.gov Identifier: NCT03471351
Recruitment Status : Terminated (At this point, the current study in HL does not fit into clinical development and regulatory strategy.)
First Posted : March 20, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Brief Summary:
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL.

Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Tenalisib Biological: Pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of RP6530, a Novel PI3K δ/γ Dual Inhibitor Given in Combination With an Anti-PD-1 Therapy, Pembrolizumab in Adult Patients With Relapsed or Refractory cHL
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : February 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tenalisib+Pembrolizumab
Participants receive Tenalisib in escalating doses Orally BID and pembrolizumab as a fixed dose intravenously (IV) in Escalation and Expansion.
Drug: Tenalisib
Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
Other Name: RP6530

Biological: Pembrolizumab
Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) for Tenalisib in combination with Pembrolizumab in patients with cHL [ Time Frame: 21 days ]
    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.


Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: 21 days ]
    Assessment of Cmax in subjects treated with RP6530 and pembrolizumab combination

  2. Overall response rate (ORR) with Tenalisib and Pembrolizumab combination [ Time Frame: 12 weeks ]
    No of patients with partial and complete response

  3. Duration of Response (DoR) with Tenalisib and Pembrolizumab combination [ Time Frame: 12 weeks ]
    The time period from the response achieved in patient until the disease progression.

  4. Progression free survival (PFS) with Tenalisib and Pembrolizumab combination [ Time Frame: 12 weeks ]
    Progression-free survival was defined as the time from enrollment in the study to disease progression

  5. Conversion Rate with Tenalisib and Pembrolizumab combination [ Time Frame: 12 weeks ]
    Defined as improved outcome status (i.e Improve from PR to CR or from SD to PR)

  6. Proportion of patients achieving CR and PR with Tenalisib and Pembrolizumab combination [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years on the day of signing informed consent.
  2. Histologically confirmed diagnosis of cHL.
  3. 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
  4. Must have ECOG performance status of 0 or 1
  5. At least one bi-dimensional measurable lesion with minimum measurement of > 15 mm in the longest diameter.
  6. Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia.

    1. 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)
    2. Absolute neutrophil count (ANC) ≥1,000/µL
    3. Platelet count ≥75,000/μL
    4. Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
    5. ALT and AST ≤2.5 x ULN
    6. Serum creatinine ≤ 1.5 x ULN or CrCl > 60 ml/min (Cockcroft-Gault formula)
  7. Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential
  8. Provide written informed consent prior to any study-specific screening procedures.
  9. Willingness and capability to comply with the requirements of the study.

Exclusion Criteria:

  1. 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,
  2. 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)
  3. Radiotherapy within the last 21 days prior to C1D1 (limited field palliative radiation is allowed if ≥ 14 days prior to C1D1);
  4. Investigational drug therapy outside of this trial during or within 3 weeks prior to C1D1.
  5. Patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1.
  6. Patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications .
  7. Pregnancy or lactation.
  8. Known clinically active CNS involvement.
  9. Evidence of active Hepatitis B, active Hepatitis C infection (HCV) or cytomegalovirus (CMV) or known history of HIV.
  10. Subjects with concomitant second malignancies
  11. Patient with any active immune toxicity of Grade 1 or greater or any other severe or Grade 3 treatment-related adverse event.
  12. History of Grade 4 anaphylactic reaction to monoclonal antibody therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471351


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
Rhizen Pharmaceuticals investigational trial site; Karmanos Cancer Institute,
Detroit, Michigan, United States, 48201
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Rhizen Pharmaceuticals SA

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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT03471351     History of Changes
Other Study ID Numbers: RP6530+Pembrolizumab-1701
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rhizen Pharmaceuticals SA:
Hodgkin lymphoma
RP6530
Pembrolizumab
Tenalisib

Additional relevant MeSH terms:
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Pembrolizumab
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents