Patients in the Phase 1b part of the study will be treated with ilixadencel at an increasing dose and frequency, in combination with standard doses and schedules of checkpoint inhibitor (CPI) pembrolizumab. The Phase 1b study will determine the optimal dose and schedule of ilixadencel. Patients in the Phase 2 part of the study will be randomly assigned to receive either ilixadencel (at the dose determined in Phase 1b) combined with the CPI, or only the CPI. Note: Recruitment to Phase 1b of the study has been completed.
Despite improvements achieved with the use of CPIs, 50-80% of cancer patients do not respond to this therapy. There is growing evidence that combining CPIs with other forms of immunotherapy has the potential to improve the desired effects of both CPIs and immunotherapies. This study looks at the safety and effectiveness of the immunotherapy ilixadencel when used in combination with a CPI. A Dose-escalation Committee (DEC) will monitor the study for any significant safety issues during Phase 1b. Note: Recruitment to Phase 1b of the study has been completed. The study did not move forward to Phase 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Intra-tumoral injection
Administered intravenously over 30 minutes, every 3 weeks, at a dose of 200 mg
Site 1010
Coral Gables, Florida, United States
Site 1006
Iowa City, Iowa, United States
Site 1011
Louisville, Kentucky, United States
Site 1004
Chapel Hill, North Carolina, United States
Site 1009
Cleveland, Ohio, United States
Frequency of adverse events (AEs) (Phase 1b)
Number of adverse events
Time frame: Up to Week 27
Severity of adverse events (AEs) (Phase 1b)
Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Week 27
Number of Dose Limiting Toxicities (DLTs) (Phase 1b)
Dose Limiting Toxicities measured using CTCAE v5.0 and protocol DLT definition.
Time frame: Up to Week 27
Number of subjects with clinically significant laboratory test abnormalities (Phase 1b)
Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Week 27
Number of subjects with vital sign abnormalities (Phase 1b)
Vital signs grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Week 27
Antitumor Objective Response Rate (ORR) (Phase 2)
Antitumor activity of ilixadencel plus CPI (checkpoint inhibitor) in each tumor type, centrally assessed using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
Time frame: Up to Week 27
Antitumor Objective Response Rate (ORR) RECIST 1.1 (Phase 1b and Phase 2)
Antitumor activity of ilixadencel plus CPI (checkpoint inhibitor) in each tumor type, investigator and centrally assessed using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
Time frame: Up to Week 27
Antitumor Objective Response Rate (ORR) iRECIST (Phase 1b and Phase 2)
Antitumor activity of ilixadencel plus CPI (checkpoint inhibitor) in each tumor type, investigator assessed using iRECIST (Immune Response Evaluation Criteria in Solid Tumors)
Time frame: Up to Week 27
Clinical Benefit Rate (Phase 1b and Phase 2)
Rate of complete and partial response and stable disease by investigator and centrally assessed RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
Time frame: Up to Week 27
Duration of response (Phase 1b and Phase 2)
Measured in weeks. Assessed using RECIST v1.1 and iRECIST
Time frame: Up to 24 months after Cycle 1 Day 1
Time to Progression (TTP) (Phase 1b and Phase 2)
Measured in weeks. Assessed using RECIST v1.1 and iRECIST
Time frame: Up to 24 months after Cycle 1 Day 1
Progression-free Survival (PFS) (Phase 1b and Phase 2)
Measured in weeks. Centrally assessed using RECIST v1.1
Time frame: Up to 24 months after Cycle 1 Day 1
Overall Survival (OS) (Phase 1b and Phase 2)
Measured in months
Time frame: Up to 5 years
Frequency of adverse events (AEs) (Phase 2)
Number of adverse events
Time frame: Up to Week 27
Severity of adverse events (AEs) (Phase 2)
Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Week 27
Number of Dose Limiting Toxicities (DLTs) (Phase 2)
Dose Limiting Toxicities measured using CTCAE v5.0 and protocol DLT definition.
Time frame: Up to week 27
Number of subjects with clinically significant laboratory test abnormalities (Phase 2)
Grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Week 27
Number of subjects with vital sign abnormalities (Phase 2)
Vital signs grading per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Up to Week 27
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