Description:
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab,
alone and in combination with other anti-cancer therapies in patients with advanced
malignancies.
Title
- Brief Title: Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
- Official Title: A First-in-Human Study of Repeat Dosing With REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1423
- SECONDARY ID:
2015-002132-41
- NCT ID:
NCT02383212
Conditions
- Advanced Cancer
- Advanced Malignancies
Interventions
Drug | Synonyms | Arms |
---|
Cemiplimab | REGN2810, Libtayo | Dual Combination Cohorts |
Cyclophosphamide | | Dual Combination Cohorts |
Docetaxel | | Dual Combination Cohorts |
Carboplatin | | Triple Combination Cohorts |
GM-CSF | LEUKINE® | Quadruple Combination Cohorts |
Paclitaxel | | Triple Combination Cohorts |
Pemetrexed | | Triple Combination Cohorts |
Purpose
This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab,
alone and in combination with other anti-cancer therapies in patients with advanced
malignancies.
Trial Arms
Name | Type | Description | Interventions |
---|
Monotherapy Cohort | Experimental | Cemiplimab will be administered alone | |
Dual Combination Cohorts | Experimental | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy
Doses of cemiplimab will be administered in combination with Cyclophosphamide
Doses of cemiplimab will be administered in combination with Docetaxel | - Cemiplimab
- Cyclophosphamide
- Docetaxel
|
Triple Combination Cohorts | Experimental | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus Cyclophosphamide
Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF
Doses of cemiplimab will be administered in combination with Carboplatin plus Paclitaxel
Doses of cemiplimab will be administered in combination with Carboplatin plus Pemetrexed
Doses of cemiplimab will be administered in combination with Carboplatin plus Docetaxel | - Cemiplimab
- Cyclophosphamide
- Docetaxel
- Carboplatin
- GM-CSF
- Paclitaxel
- Pemetrexed
|
Quadruple Combination Cohorts | Experimental | Doses of cemiplimab will be administered in combination with hypofractionated radiotherapy plus GM-CSF plus Cyclophosphamide | - Cemiplimab
- Cyclophosphamide
- GM-CSF
|
Eligibility Criteria
Key Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated
progression of a solid tumor (non-lymphoma) with no alternative standard-of-care
therapeutic option (certain exceptions may apply).
2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key Exclusion Criteria:
1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments, which may suggest risk
for immune-related adverse events (irAEs). The following are not exclusionary:
vitiligo, childhood asthma that has resolved, residual hypothyroidism that required
only hormone replacement or psoriasis that does not require systemic treatment.
2. Prior treatment with an agent that blocks the programmed death-1/ programmed
death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to
the first dose of cemiplimab. Examples of immune modulating agents include blockers of
CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
4. Untreated brain metastasis(es) that may be considered active. Patients with previously
treated brain metastases may participate provided they are stable (i.e., without
evidence of progression by imaging for at least 6 weeks prior to the first dose of
study treatment, and any neurologic symptoms have returned to baseline), and there is
no evidence of new or enlarging brain metastases, and the patient does not require any
systemic corticosteroids for management of brain metastases within 4 weeks prior to
the first dose of cemiplimab (certain exceptions may apply).
5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
4 weeks prior to the first dose of cemiplimab
The information provided above is not intended to contain all considerations relevant to
potential participation in a clinical trial, therefore not all inclusion/ exclusion
criteria are listed.
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: | Change from baseline to week 48 |
Safety Issue: | |
Description: | Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs) |
Secondary Outcome Measures
Measure: | Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) |
Time Frame: | Change from baseline to week 48 |
Safety Issue: | |
Description: | |
Measure: | Immune-Related Response Criteria (irRC) applied to RECIST measurements |
Time Frame: | Change from baseline to week 48 |
Safety Issue: | |
Description: | |
Measure: | Incidence of development of anti-cemiplimab antibodies |
Time Frame: | Up to week 48 |
Safety Issue: | |
Description: | |
Measure: | Antitumor activity measured by progression-free survival (PFS) |
Time Frame: | Up to 72 weeks |
Safety Issue: | |
Description: | |
Measure: | Antitumor activity measured by overall survival |
Time Frame: | Up to 249 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Advanced cancerous growth
Last Updated
January 27, 2020