Study of Cemiplimab and REGN1979 in Patients With Lymphoma
Study Details
Study Description
Brief Summary
This is an open-label, multicenter, dose escalation study of cemiplimab and REGN1979 in patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on how an individual patient responds to treatment. The follow-up period will be 6 months for all patients.
The primary objective of the study is to assess safety, tolerability and dose-limiting toxicity (DLT) of:
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Single-agent cemiplimab in patients with lymphoma (B-NHL and HL)
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Combination REGN1979 and cemiplimab in patients with B-NHL
The secondary objectives of the study are:
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To determine a recommended dose for:
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Cemiplimab as a single-agent in patients with lymphoma (B-NHL and HL)
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REGN1979 and cemiplimab administered in combination in patients with B-NHL
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To characterize the pharmacokinetic (PK) profile of cemiplimab when administered as a single agent and of cemiplimab and REGN1979 when administered in combination
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To assess the immunogenicity of cemiplimab when administered alone and the immunogenicity of cemiplimab and REGN1979 when administered in combination
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To study the preliminary antitumor activity of cemiplimab as a single agent and of the combination of cemiplimab and REGN1979 in specific indications, as measured by overall response rate, MRD in patients with bone marrow disease at baseline, duration of response, and median progression-free survival and rates at 6 and 12 months
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Open label (cemiplimab) Experimental cohorts will consist of multiple dose levels of cemiplimab administered intravenously (IV) every 2 weeks (Q2W) |
Drug: cemiplimab
Multiple dose levels administered IV Q2W
Other Names:
|
Experimental: Open label (cemiplimab and REGN1979) Experimental cohorts will consist of a single dose level of cemiplimab administered intravenously (IV) and multiple dose levels of REGN1979 administered intravenously (IV) |
Drug: cemiplimab
Multiple dose levels administered IV Q2W
Other Names:
Drug: REGN1979
Single dose level of cemiplimab and multiple dose levels of REGN1979 administered IV
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment emergent adverse events (TEAEs) [Up to 18 months]
TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)
Secondary Outcome Measures
- Pharmacokinetics (PK) of cemiplimab when given alone, and of cemiplimab and REGN1979 when given in combination [Up to 18 months]
PK variables of cemiplimab may include, but are not limited to, the following: Area under the concentration-time curve (AUC) over a dosing interval, the peak concentration and last positive (quantifiable) concentration
- Antitumor activity (includes response evaluation per Cheson and Lugano criteria) [Up to 18 months]
Eligibility Criteria
Criteria
Key Inclusion Criteria [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:
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Have documented CD20+ B-cell NHL or documented HL, with active disease that is either not responsive to or relapsed after prior therapy, for whom no standard of care options exists.
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Must have at least 1 bi-dimensionally measurable lesion (≥1.5 cm) documented by diagnostic imaging (CT, PET-CT or MRI).
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Eastern Cooperative Oncology Group (ECOG) performance status ≤1
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Life expectancy of at least 6 months
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Adequate bone marrow function
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Adequate organ function
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Willing and able to comply with clinic visits and study-related procedures
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Provide signed informed consent
Key Exclusion Criteria (NHL and HL):
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Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by nonprimary CNS NHL
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History of or current relevant CNS pathology
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Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs
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Prior allogeneic stem cell transplantation
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Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
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Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
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History of hypersensitivity to any compound in the tetracycline antibiotics group
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Known hypersensitivity to both allopurinol and rasburicase
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Pregnant or breastfeeding women
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Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study
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Prior treatment with idelalisib
Note: Other protocol Inclusion/Exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Regeneron Research Facility | Santa Monica | California | United States | 90404 |
2 | Regeneron Research Facility | Baltimore | Maryland | United States | 21287 |
3 | Regeneron Research Facility | Boston | Massachusetts | United States | 02215 |
4 | Regeneron Research Facility | Grand Rapids | Michigan | United States | 49503 |
5 | Regeneron Research Facility | Lebanon | New Hampshire | United States | 03756 |
6 | Regeneron Research Facility | New York | New York | United States | 10065 |
7 | Regeneron Research Facility | Cleveland | Ohio | United States | 44106 |
8 | Regeneron Research Facility | Cleveland | Ohio | United States | 44195 |
9 | Regeneron Research Facility | Philadelphia | Pennsylvania | United States | 19104 |
10 | Regeneron Research Facility | San Antonio | Texas | United States | 78229 |
11 | Regeneron Research Facility | Heidelberg | Baden-Wurttemberg | Germany | 69120 |
12 | Regeneron Research Facility | Cologne | Germany | 50937 | |
13 | Regeneron Research Facility | Frankfurt | Germany | 60590 | |
14 | Regeneron Research Facility | Jena | Germany | 07747 | |
15 | Regeneron Research Facility | Kiel | Germany | 24105 | |
16 | Regeneron Research Facility | Würzburg | Germany | 97080 | |
17 | Regeneron Research Facility | Barcelona | Spain | 08035 | |
18 | Regeneron Research Facility | Madrid | Spain | 28033 | |
19 | Regeneron Research Facility | Madrid | Spain | 28040 | |
20 | Regeneron Research Facility | Madrid | Spain | 28041 | |
21 | Regeneron Research Facility | Majadahonda | Spain | 28222 | |
22 | Regeneron Research Facility | Salamanca | Spain | 37007 |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R1979-ONC-1504
- 2015-001697-17