The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: * To characterize the safety profile of cemiplimab + ISA101b * To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Administered intravenously (IV) every three weeks (Q3W)
Administered by subcutaneous (SC) injection on day 1, day 29, and day 50
Arizona Oncology Associates
Tucson, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
Regeneron Research Site
Orange, California, United States
Universitair Ziekenhuis Gent
Ghent, East Flanders, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
CHIREC Delta Hospital / Chirec Cancer Institute
Objective Response Rate (ORR)
Objective response rate (ORR) is determined by the proportion of participants with best overall response of complete response (CR) or partial response (PR) in the Full analysis set (FAS).
Time frame: From enrollment to last dose (~up to 23 months)
Number of Treatment Emergent Adverse Events (TEAEs)
Treatment-emergent AEs (TEAEs) are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period.
Time frame: From enrollment to last dose (~up to 23 months)
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
Time frame: From enrollment to last dose (~up to 23 months)
Number of Participants With Any Treatment Emergent Adverse Events of Special Interest (TE AESIs)
Time frame: From enrollment to last dose (~up to 23 months)
Number of Participants With Any Serious TEAE
Time frame: From enrollment to last dose (~up to 23 months)
Number of Participants With at Least One Lab Abnormality
Time frame: From enrollment to last dose (~up to 23 months)
Number of Participants With at Least One Lab Abnormality With Severity of ≥ Grade 3
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: From enrollment to last dose (~up to 23 months)
Duration of Response (DOR)
Time frame: From enrollment to last dose (~up to 23 months)
Progression Free Survival (PFS)
Time frame: From enrollment to last dose (~up to 23 months)
Overall Survival (OS)
Time frame: From enrollment to last dose (~up to 23 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Brussels, Belgium
Instituto Nacional de Cancer Jose Alencar Gomes da Silva ¿ INCA
Santo Cristo, Rio de Janeiro, Brazil
Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro De Novos Tratamentos Itajai
Itajaí, Santa Catarina, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
...and 16 more locations