This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). The name of the drug involved in this research study is: -cosibelimab (a type of an anti-PD-L1 antibody)
This is a Phase IV, multi-site, multi-cohort, open-label clinical trial investigating the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC). Checkpoint Therapeutics is supporting this research study by providing the study drug, cosibelimab. Participants will be enrolled into one of two study groups: Group A or Group B. Cosibelimab is FDA-approved for the treatment of advanced cutaneous squamous cell carcinoma The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, or Positron Emission (PET) scans, electrocardiograms (ECGs), Tumor biopsies and aspirations. It is expected that about 80 people will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Anti-PD-L1 antibody, single dose vials, via intravenous (into the vein) infusion per protocol
Corticosteroid, per standard of care
mTOR Inhibitor, per standard of care
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Best Overall Response Rate (BORR)
BORR is defined as the proportion of participants whose best overall responses are complete metabolic response (CMR) and partial metabolic response (PMR). Per PERCIST 1.0 for target lesions, CMR is visual disappearance of all metabolically active tumor, and PMR is at least a 30% decrease in SUL peak (minimum 0.8-unit decrease) in the lesion with greatest uptake, not necessarily the same lesion.
Time frame: Up to 102 weeks.
Treatment-Emergent Adverse Events (TEAEs) Rate
TEAEs rate is defined as the proportion of participants who experience one or more adverse events that emerge or worsen after the initiation of study treatment.
Time frame: Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
Immune-related Adverse Events (AE) Rate
The immune-related AE rate is defined as the proportion of participants who experience at least one adverse event considered by the investigator to be immune-related during the study treatment period.
Time frame: Treatment duration is up to 51 weeks, and adverse events will be collected through 30 days following the end of treatment.
Allograft Rejection and Allograft Loss Rate in Cohort A
Allograft rejection loss rate is defined as the proportion of participants in Cohort A who experience allograft rejection or allograft loss, as determined by elevated serum creatinine, urine protein levels, donor-derived cell-free DNA (dd-cfDNA), renal biopsy findings, or the need for renal replacement therapy.
Time frame: Up to 51 weeks.
Median Progression-Free Survival (PFS)
PFS is defined as the time from registration to the earlier of progressive metabolic disease (PMD), as defined by PERCIST 1.1, or death from any cause. PFS will be estimated using the Kaplan-Meier method. Participants who are alive without documented disease progression at the time of analysis will be censored at the date of their last disease evaluation.
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mTOR Inhibitor, per standard of care
Time frame: Tumor assessments will be performed before Cycle 3, 5 Day 1 (28-day cycles) and every 4 cycles through Cycle 17. Follow-up assessments will occur on Cycle 18, 21, 29, and 33 Day 1.
Duration of Response (DOR)
DOR, defined according to PERCIST 1.1, is measured using the Kaplan-Meier method from the first documentation of complete metabolic response (CMR) or partial metabolic response (PMR), whichever occurs first, to the earliest date of objectively documented recurrent or progressive metabolic disease (PMD), using the lowest recorded measurements since treatment initiation as the reference, or death from any cause. Participants without documented events will be censored at the date of their last disease evaluation.
Time frame: 2 years
Median Overall Survival (OS)
OS based on Kaplan-Meier method is defined as time from date of first dose until the date of death due to any cause. Participants are censored as date last known alive.
Time frame: Up to 147 weeks
Median Disease Specific Survival (DSS)
DSS based on Kaplan-Meier method is defined as the time from study enrollment to death specifically due to advanced cutaneous squamous cell carcinoma (CSCC). Deaths from other causes are censored at the time of occurrence.
Time frame: Up to 102 weeks.
Median Circulating Tumor DNA (ctDNA) Levels
ctDNA will be assessed from plasma using a personalized mPCR-NGS-based assay (Signatera™). ctDNA levels will be quantified as mean tumor molecules per milliliter of plasma (MTM/mL).
Time frame: Up to 102 weeks.