Charité - Universitätsmedizin Berlin 10117 Berlin (Berlin) GermanyRekrutierend» Google-Maps Ansprechpartner: Thomas Eigentler, MD» Ansprechpartner anzeigenUniversitätsmedizin der Johannes Gutenberg, Universität Mainz 55131 Mainz (Rheinland-Pfalz) GermanyRekrutierend» Google-Maps Ansprechpartner: Stephan Grabbe, MD» Ansprechpartner anzeigenUniversity of Alabama at Birmingham 35294 Birmingham United StatesRekrutierend» Google-Maps Ansprechpartner: John Dubay, MD» Ansprechpartner anzeigen
1. Monotherapy Dose Expansion: Objective Response Rate (ORR) as defined by RECIST v1.1 (Time Frame - Day 1 up to 12 months)
2. Combination Dose Finding: Incidence, frequency, and severity of Adverse Events with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 13 months)
3. Combination Dose Finding: Recommended Phase 2 Dose of ANV419 in combination with pembrolizumab (Time Frame - Day 1 up to Day 42)
4. Combination Dose Finding: Recommended Phase 2 Dose of ANV419 in combination with ipilimumab (Time Frame - Day 1 up to Day 42)
5. Combination Dose Expansion: Objective Response Rate (ORR) as defined by RECIST, with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 12 months)
Secondary outcome:
1. Monotherapy Dose Expansion: Tumor response in terms of Objective Response Rate (ORR) assessed by iRECIST (Time Frame - Day 1 up to 12 months)
2. Monotherapy Dose Expansion: Duration of Response (DOR) according to iRECIST and iRECIST (Time Frame - Day 1 up to 12 months)
3. Monotherapy Dose Expansion: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)
4. Monotherapy Dose Expansion: Progression-free survival (PFS) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)
5. Monotherapy Dose Expansion: Overall survival (OS) (Time Frame - Day 1 up to 13 months)
6. Monotherapy Dose Expansion: Median Time To Response (MTT and iMTT) (Time Frame - Day 1 up to 12 months)
7. Monotherapy Dose Expansion: Incidence, frequency, and severity of Adverse Events (Time Frame - Day 1 up to 13 months)
8. Monotherapy Dose Expansion: Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)
9. Combination Dose Finding: Serum concentration of ANV419 in blood (Time Frame - Day 1 up to 12 months)
10. Combination Dose Finding: Impact of ANV419 on the expression of markers of PBMC lineage in blood (Time Frame - Day 1 up to 12 months)
11. Combination Dose Finding: Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)
12. Combination Dose Finding: Objective Response Rate (ORR) as defined by RECIST, with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 12 months)
13. Combination Dose Finding: Duration of Response (DOR) according to iRECIST and iRECIST (Time Frame - Day 1 up to 12 months)
14. Combination Dose Finding: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)
15. Combination Dose Finding: Progression-free survival (PFS) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)
16. Combination Dose Finding: Overall survival (OS) (Time Frame - Day 1 up to 13 months)
17. Combination Dose Finding: Median Time To Response (MTT and iMTT) (Time Frame - Day 1 up to 12 months)
18. Combination Dose Finding: Quality of life assessed with European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) (Time Frame - Day 1 up to 12 months)
19. Combination Dose Finding: Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Day 1 up to 12 months)
20. Combination Dose Expansion: Incidence, frequency, and severity of Adverse Events with ANV419 in combination with pembrolizumab or ipilimumab (Time Frame - Day 1 up to 13 months)
21. Combination Dose Expansion: Quality of life assessed with European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) (Time Frame - Day 1 up to 12 months)
22. Combination Dose Expansion: Quality of life assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (Time Frame - Day 1 up to 12 months)
23. Combination Dose Expansion: Levels of specific anti-ANV419 antibodies in blood (Time Frame - Day 1 up to 12 months)
24. Combination Dose Expansion: Duration of Response (DOR) according to iRECIST and iRECIST (Time Frame - Day 1 up to 12 months)
25. Combination Dose Expansion: Duration of Complete Response (DCR) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)
26. Combination Dose Expansion: Progression-free survival (PFS) according to RECIST v1.1 and iRECIST (Time Frame - Day 1 up to 12 months)
27. Combination Dose Expansion: Overall survival (OS) (Time Frame - Day 1 up to 13 months)
28. Combination Dose Expansion: Median Time To Response (MTT and iMTT) (Time Frame - Day 1 up to 12 months)