Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors
Conditions
Keywords
Advanced solid organ malignancies, Locally advanced, Metastatic, Non-uveal, Unresectable, Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1)
Brief summary
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug(s) are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Detailed description
Phase 1: Conducted in the United States only Phase 2: Conducted globally
Interventions
DRUGREGN10597
Administered per the protocol
DRUGCemiplimab
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Dose escalation cohorts: 1\. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available Dose expansion cohorts: 1\. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol: * Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or * Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or * Module 2, Cohort 1: 1L Melanoma ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points Key
Exclusion criteria
1. Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy 2. Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol 3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs 4. Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities 5. Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol 6. Has known allergy or hypersensitivity to components of the study drug(s) 7. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention 8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments NOTE: Other Protocol Defined Inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | Up to Day 29 | Dose escalation |
| Incidence of Treatment-Emergent Adverse Event (TEAEs) | Approximately 6 Years | Dose escalation |
| Incidence of Serious Adverse Events (SAEs) | Approximately 6 Years | Dose escalation |
| Incidence of TEAEs leading to treatment discontinuation | Approximately 6 Years | Dose escalation |
| Incidence of TEAEs leading to death | Approximately 6 Years | Dose escalation |
| Number of participants with Grade 3 laboratory abnormalities | Approximately 6 Years | Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment | Approximately 6 Years | Dose expansion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR based on RECIST 1.1 criteria by investigator assessment | Approximately 6 Years | Dose escalation |
| Best Overall Response (BOR) based on RECIST 1.1 criteria | Approximately 6 Years | — |
| Duration Of Response (DOR) based on RECIST 1.1 criteria | Approximately 6 Years | — |
| Disease control rate based on RECIST 1.1 | Approximately 6 Years | — |
| Time to response based on RECIST 1.1 | Approximately 6 Years | — |
| Progression Free Survival (PFS) based on RECIST 1.1 | Approximately 6 Years | — |
| Concentrations of REGN10597 in serum | Approximately 6 Years | — |
| Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time | Approximately 6 Years | — |
| Magnitude of ADA to REGN10597 over time | Approximately 6 Years | — |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed