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)
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
Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
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
Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
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
Sequential
REGN10597
DrugAdministered per the protocol
Cemiplimab
DrugAdministered per the protocol
Incidence of Dose-Limiting Toxicities (DLTs)
Dose escalation
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Dose escalation
Incidence of Serious Adverse Events (SAEs)
Dose escalation
Incidence of TEAEs leading to treatment discontinuation
Dose escalation
ORR based on RECIST 1.1 criteria by investigator assessment
Dose escalation
Best Overall Response (BOR) based on RECIST 1.1 criteria
Duration Of Response (DOR) based on RECIST 1.1 criteria
Disease control rate based on RECIST 1.1
Click on the lead sponsor to view all of their trials.
