At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
CyPep-1 +1 moredrug
Likely dose
Pembrolizumab 25 MG/ML [KEYTRUDA®]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A First-in-human, Open-label Dose Escalation Followed by Dose Expansion Phase I/IIa Trial to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Intratumoral CyPep-1 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Cancers.
In Brief
A Phase 2 clinical trial evaluating CyPep-1 and Pembrolizumab 25 MG/ML [KEYTRUDA®] for Advanced Solid Tumor Malignancy. Completed, enrolled 60 participants across 8 sites in 3 countries.
Detailed Summary
This Phase I/IIa trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CyPep-1 when administered directly into malignant tumors in monotherapy and in combination with anti programmed cell death protein 1(anti-PD-1) antibody pembrolizumab. Additionally, the trial will monitor anti-tumor effects on both injected lesions and distant non-injected deposits.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumor Malignancy
CountriesFrance, Netherlands, Spain
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 2020
Enrollment StartApr 2020
Primary CompletionJul 2024
TodayJul 2026
First PostedFeb 7, 2020
Enrollment StartApr 30, 2020
Primary CompletionJul 5, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.4 years ago
Interventions
CyPep-1drug
Intratumoral injection
Pembrolizumab 25 MG/ML [KEYTRUDA®]drug
IV infusion