Advanced Cancer, Advanced Malignancies
Conditions
Keywords
Advanced cancerous growth
Brief summary
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.
Interventions
DRUGCemiplimab
RADIATIONHypofractionated radiotherapy
DRUGCyclophosphamide
DRUGDocetaxel
DRUGCarboplatin
DRUGGM-CSF
DRUGPaclitaxel
DRUGPemetrexed
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Change from baseline to week 48 | Primary safety variables include incidence and severity of TEAEs, abnormal laboratory findings and number of participants with dose limiting toxicities (DLTs) |
| Incidence of abnormal laboratory findings | Change from baseline to week 48 | — |
| Number of participants with dose limiting toxicities (DLTs) | Change from baseline to 28 days after first dose of cemiplimab | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor activity measured by progression-free survival (PFS) | Up to 72 weeks |
| Response Evaluation Criteria in Solid Tumors (RECIST) as measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) | Change from baseline to week 48 |
| Antitumor activity measured by overall survival | Up to 249 weeks |
| Immune-Related Response Criteria (irRC) applied to RECIST measurements | Change from baseline to week 48 |
| Incidence of development of anti-cemiplimab antibodies | Up to week 48 |
Countries
Australia, Spain, United States
Outcome results
None listed