Description:
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:
- Single-agent cemiplimab in patients with lymphoma (B-NHL and HL)
- Combination REGN1979 and cemiplimab in patients with B-NHL
The secondary objectives of the study are:
- To determine a recommended dose for:
- Cemiplimab as a single-agent in patients with lymphoma (B-NHL and HL)
- REGN1979 and cemiplimab administered in combination in patients with B-NHL
- To characterize the pharmacokinetic (PK) profile of cemiplimab when administered as a
single agent and of cemiplimab and REGN1979 when administered in combination
- To assess the immunogenicity of cemiplimab when administered alone and the
immunogenicity of cemiplimab and REGN1979 when administered in combination
- 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
Title
- Brief Title: Study of Cemiplimab and REGN1979 in Patients With Lymphoma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
R1979-ONC-1504
- SECONDARY ID:
2015-001697-17
- NCT ID:
NCT02651662
Conditions
Interventions
Drug | Synonyms | Arms |
---|
cemiplimab | REGN2810, Libtayo | Open label (cemiplimab and REGN1979) |
REGN1979 | | Open label (cemiplimab and REGN1979) |
Purpose
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:
- Single-agent cemiplimab in patients with lymphoma (B-NHL and HL)
- Combination REGN1979 and cemiplimab in patients with B-NHL
The secondary objectives of the study are:
- To determine a recommended dose for:
- Cemiplimab as a single-agent in patients with lymphoma (B-NHL and HL)
- REGN1979 and cemiplimab administered in combination in patients with B-NHL
- To characterize the pharmacokinetic (PK) profile of cemiplimab when administered as a
single agent and of cemiplimab and REGN1979 when administered in combination
- To assess the immunogenicity of cemiplimab when administered alone and the
immunogenicity of cemiplimab and REGN1979 when administered in combination
- 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
Trial Arms
Name | Type | Description | Interventions |
---|
Open label (cemiplimab) | Experimental | Experimental cohorts will consist of multiple dose levels of cemiplimab administered intravenously (IV) every 2 weeks (Q2W) | |
Open label (cemiplimab and REGN1979) | Experimental | Experimental cohorts will consist of a single dose level of cemiplimab administered intravenously (IV) and multiple dose levels of REGN1979 administered intravenously (IV) | |
Eligibility Criteria
Key Inclusion Criteria [(Non-Hodgkin Lymphoma (NHL) and Hodgkin Lymphoma (HL)]:
1. 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.
2. Must have at least 1 bi-dimensionally measurable lesion (≥1.5 cm) documented by
diagnostic imaging (CT, PET-CT or MRI).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
4. Life expectancy of at least 6 months
5. Adequate bone marrow function
6. Adequate organ function
7. Willing and able to comply with clinic visits and study-related procedures
8. Provide signed informed consent
Key Exclusion Criteria (NHL and HL):
1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement
by nonprimary CNS NHL
2. History of or current relevant CNS pathology
3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments, which may suggest risk
for iAEs
4. Prior allogeneic stem cell transplantation
5. Prior treatment with an agent that blocks the programmed death-1/ programmed
death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
6. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or
hepatitis C infection or other uncontrolled infection
7. History of hypersensitivity to any compound in the tetracycline antibiotics group
8. Known hypersensitivity to both allopurinol and rasburicase
9. Pregnant or breastfeeding women
10. Continued sexual activity in men or women of childbearing potential who are unwilling
to practice adequate contraception during the study
11. Prior treatment with idelalisib
Note: Other protocol Inclusion/Exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of treatment emergent adverse events (TEAEs) |
Time Frame: | Up to 18 months |
Safety Issue: | |
Description: | TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Pharmacokinetics (PK) of cemiplimab when given alone, and of cemiplimab and REGN1979 when given in combination |
Time Frame: | Up to 18 months |
Safety Issue: | |
Description: | 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 |
Measure: | Antitumor activity (includes response evaluation per Cheson and Lugano criteria) |
Time Frame: | Up to 18 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Last Updated
August 4, 2020