EUCTR2015-001697-17-DE
Active, not recruiting
Phase 1
A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an anti-CD20 x anti- CD3 bispecific monoclonal antibody, and REGN2810, an anti-programmed death-1 monoclonal antibody, in Patients with B-cell Malignancies
Regeneron Pharmaceuticals, Inc0 sites172 target enrollmentJune 30, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Regeneron Pharmaceuticals, Inc
- Enrollment
- 172
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\-Principal Inclusion Criteria for B\-NHL and HL Treatment Arms:
- •Hematologic malignancy defined by either:
- •a. NHL: Documented CD20\+ B\-cell malignancy, with active disease that is either refractory to or relapsed after most recent prior therapy, for whom no standard of care options exist, and for whom treatment with an anti\-CD20 antibody may be appropriate:
- •i. B\-NHL per WHO 2008 criteria (Campo 2011\)
- •b. Documented HL, per WHO 2008 criteria (Campo 2011\), with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist (cemiplimab single agent therapy cohorts ONLY)
- •All patients must have at least one bi\-dimensionally measurable lesion (\=1\.5 cm) documented by diagnostic imaging (CT, PET\-CT, or MRI).
- •Eastern Cooperative Oncology Group (ECOG) performance status \=1\. Note: Individual cases of patients with ECOG 2 performance status may be discussed with the medical monitor for potential enrollment.
- •Age \=18 years
- •Adequate bone marrow function documented by:
- •a. Platelet counts \=75 x 109/L
Exclusion Criteria
- •1\-Principal Exclusion Criteria for B\-NHL and HL Treatment Arms
- •Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non\-primary CNS NHL
- •History of or current relevant CNS pathology
- •Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs
- •History of treatment\-related iAEs from immune\-modulatory agents
- •Standard or investigational anti\-neoplastic therapy (nonbiologic) within 5\-times the half life or within 28 days, whichever is shorter, prior to first administration of study drug
- •Standard radiotherapy within 14 days of first administration of study drug
- •Treatment with alemtuzumab within 12 weeks prior to first administration of study drug(s)
- •Treatment with rituximab, immune\-modulating agents or other investigational or commercial biologic agent less than 28 days prior to first administration of study drug(s).
- •Prior allogeneic stem cell transplantation
Outcomes
Primary Outcomes
Not specified
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