The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Subcutaneous (SC) injection.
Intravenous (IV) infusion via peripheral or central venous line.
Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With a Treatment-emergent Adverse Event
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With an Adverse Event of Special Interest
Time frame: Day 1 up to approximately 2 years and 2 months
Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to iRECIST: Complete Response
Time frame: Day 1 up to approximately 2 years and 2 months
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Innovative Clinical Research Institute
Whittier, California, United States
University of Pittsburg Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Institut Jules Bordet
Anderlecht, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Grand Hospital de Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Masarykuv Onkologicky Ustav
Brno, Czechia
Nemocnice Hořovice
Hořovice, Czechia
Fakultní nemocnice Olomouc
Olomouc, Czechia
...and 44 more locations
Number of Patients With Best Overall Response According to iRECIST: Partial Response
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to iRECIST: Stable Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Duration of Response According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Duration of Response According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Percentage of Patients With Clinical Benefit Rate According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
Progression-free Survival According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Progression-free Survival According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
Time to Response According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Time to Response According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years
Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years
Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration
Time frame: Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration
Time frame: Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration
Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1
Time frame: Cycle 4 Day 1, approximately 9 weeks