Last reviewed · How we verify
Immuno-pet IMaging ResPonses AdministeRed Immune CheckpoiNt InhibiTor (IMPRINT)
This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with \[89Zr\]crefmirlimab berdoxam PET imaging as an imaging biomarker.
Details
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 20 |
| Start date | 2025-02 |
| Completion | 2027-03 |
Conditions
- NSCLC
Interventions
- Sasanlimab
- non-ablative radiotherapy
- [89Zr]Zr-crefmirlimab berdoxam
Primary outcomes
- Number of participants with successful completion of curative surgery within 42 days after start of subcutaneous sasanlimab as neo-adjuvant treatment. — 2 years
Feasibility will be determined on all patients who have entered the treatment phase of the study, i.e. received at least one course of neo-adjuvant sasanlimab. Feasibility is defined as successful completion of curative surgery within 42 days after start of neo-adjuvant treatment (= day 1). No delays will be allowed. Results will be reported in a descriptive fashion, including percentages, mean and standard deviation, median and range for the time-related measures. - The number of CTC grade ≥3 toxicity related to subcutaneous sasanlimab as neo-adjuvant treatment. — 2 years
Safety will be defined as the number of CTC grade ≥3 toxicity related to neo-adjuvant sasanlimab. Results will be reported in a descriptive fashion. - Detection of treatment induced immune related responses after subcutaneous sasanlimab as neo-adjuvant treatment. — 2 years
Efficacy will be defined as the detection of treatment induced immune related responses in \>15% of the patients. Results will be reported in a descriptive fashion, for both cohorts of each n=10 patients (sasanlimab with and without radiotherapy).
Countries
Germany, Netherlands