The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are: * How many participants' cancers respond to vidutolimod together with cemiplimab? * Is vidutolimod together with cemiplimab safe and well-tolerated? * How well does vidutolimod together with cemiplimab treat participants' cancer? Participants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.
Former Sponsor Checkmate Pharmaceuticals Note: Early termination planned on 31Oct2024 due to study drug supply
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Participants will receive vidutolimod for up to 2 years as follows: 10 mg IT weekly for 7 doses after which vidutolimod will be administered every 3 weeks (Q3W). The first dose of vidutolimod may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT. The initial 7 doses of vidutolimod, delivered on a weekly dosing schedule, must be completed before starting the Q3W vidutolimod dosing schedule.
Participants will receive cemiplimab for up to 2 years as follows: 350 mg IV infusion over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
University of Alabama
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California
Los Angeles, California, United States
GenesisCare USA
Jacksonville, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
VA Maryland Health Care System
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
...and 14 more locations
Objective Response Rate (ORR)
ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Time frame: Up to 31.5 Months
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.
Time frame: Up to 31.5 months
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event
Time frame: Up to 31.5 months
Duration of Response (DOR)
DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator
Time frame: Up to 31.5 months
Progression Free Survival (PFS)
PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first
Time frame: Up to 31.5 months
Overall Survival (OS)
OS is defined as the time from date of first dose of study treatment to date of death
Time frame: Up to 31.5 months
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