2. Phase 2: Dose Expansion: AEs (Time Frame - 50 Weeks): Proportion of patients with AEs following treatment initiation by severity grade.
3. Phase 2: Dose Expansion: Discontinuation due to adverse reaction (Time Frame - 50 weeks): Proportion of patients who discontinue due to an adverse reaction.
4. Phase 2: Dose Expansion: Objective Response Rate (ORR) (Time Frame - 50 weeks): Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.
5. Phase 2: Dose Expansion: Immune response (Time Frame - 50 weeks): Proportion of patients with increased HPV16 E6/E7-specific cellular immune responses from baseline as measured by E6/E7-IFN-γ ELISpot in post-vaccination samples.
6. Phase 1+2: Full trial: Objective Response Rate (ORR) (Time Frame - 50 weeks): Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response (BOR) per RECIST 1.1.
7. Phase 1+2: Full trial: Objective Response Rate (ORR) (Time Frame - 103 weeks): Objective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.
8. Phase 1+2: Full trial: Duration of response (DOR) (Time Frame - 50 weeks): Duration of response (DOR), defined as time from the date of first documented response of CR or PR to the date of the first documented progression or death due to any cause.
9. Phase 1+2: Full trial: Duration of response (DOR) (Time Frame - 103 weeks): Duration of response (DOR), defined as time from the date of first documented response of CR or PR to the date of the first documented progression or death due to any cause.
10. Phase 1+2: Full trial: Progression-free survival (PFS) (Time Frame - 50 weeks): Progression-free survival (PFS), defined as the time from the VB10.16 treatment start date to the date of the first documented progression or death from any cause, whichever occurs first.
11. Phase 1+2: Full trial: Progression-free survival (PFS) (Time Frame - 103 weeks): Progression-free survival (PFS), defined as the time from the VB10.16 treatment start date to the date of the first documented progression or death from any cause, whichever occurs first.
12. Phase 1+2: Full trial: Proportion Progression-free (Time Frame - 50 weeks): Proportion of patients who progression-free and alive.
13. Phase 1+2: Full trial: Proportion Progression-free (Time Frame - 103 weeks): Proportion of patients who are progression-free and alive.
14. Phase 1 + 2: Full trial: Overall survival (OS) (Time Frame - 50 weeks): Overall survival (OS), defined as the time from VB10.16 treatment start date to the date of death from any cause.
15. Phase 1 + 2: Full trial: Overall survival (OS) (Time Frame - 103 weeks): Overall survival (OS), defined as the time from VB10.16 treatment start date to the date of death from any cause.
16. Phase 1 + 2: Full trial: Proportion alive (Time Frame - 50 weeks): Proportion of patients who are alive.
17. Phase 1 + 2: Full trial: Proportion alive (Time Frame - 103 weeks): Proportion of patients who are alive.
Secondary outcome:
1. Phase 2: Dose Expansion: Disease control rate (DCR) (Time Frame - 50 weeks): Disease control rate (DCR), defined as the proportion of patients who have either confirmed CR, confirmed PR, or SD as BOR according to RECIST 1.1.
2. Phase 2: Dose Expansion: Duration of response (DOR) (Time Frame - 50 weeks): Duration of response (DOR), defined as time from the date of first documented response of CR or PR to the date of the first documented progression or death due to any cause.
3. Phase 2: Dose Expansion: Duration of complete response (DOCR) (Time Frame - 50 weeks): Duration of complete response (DOCR), defined as time from the date of first documented response of CR to the date of the first documented progression or death due to any cause.
4. Phase 2: Dose Expansion: Duration of Disease Control (DODC) (Time Frame - 50 weeks): Duration of Disease Control (DODC), defined as time from the date of first documented response of CR, PR or SD to the date of the first documented progression or death due to any cause.
5. Phase 2: Dose Expansion: Time to Response (TTR) (Time Frame - 50 weeks): Time to Response (TTR), s defined as the time from VB10.16 treatment start date to the date of first documented response of either confirmed CR or confirmed PR.
6. Phase 2: Dose Expansion: Progression-free survival (PFS) (Time Frame - 50 weeks): Progression-free survival (PFS), defined as the time from the VB10.16 treatment start date to the date of the first documented progression or death from any cause, whichever occurs first.
7. Phase 2: Dose Expansion: Overall Survival (OS) (Time Frame - 50 weeks): Overall survival (OS), defined as the time from VB10.16 treatment start date to the date of death from any cause.
8. Phase 2: Proportion of progression-free (Time Frame - 26 weeks): Proportion of patients who are progression-free and alive.
9. Phase 2: Proportion of progression-free (Time Frame - 50 weeks): Proportion of patients who are progression-free and alive.
10. Phase 2: Patients alive (Time Frame - 26 weeks): Proportion of patients who are alive.
11. Phase 2: Patients alive (Time Frame - 50 weeks): Proportion of patients who are alive.
12. Phase 1+2: Full trial: AEs following treatment initiation (Time Frame - 50 weeks): Proportion of patients with AEs following treatment initiation by severity grade.
13. Phase 1+2: Full trial: AEs following treatment initiation (Time Frame - 103 weeks): Proportion of patients with AEs following treatment initiation by severity grade.
14. Phase 1+2: Discontinuation due to an adverse reaction (Time Frame - 50 weeks): Proportion of patients who discontinue due to an adverse reaction.
15. Phase 1+2: Discontinuation due to an adverse reaction (Time Frame - 103 weeks): Proportion of patients who discontinue due to an adverse reaction.
Experimental: Phase1: Dose Escalation: 3 mg VB10.16 + Pembrolizumab 3 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
Experimental: Phase 1: Dose Escalation: 6 mg VB10.16 + Pembrolizumab 6 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps or gluteus muscles
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
Experimental: Phase 1: Dose Escalation: 9 mg VB10.16 + Pembrolizumab 9 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles and quadriceps and/or gluteus muscle
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
Experimental: Phase 2: Dose Expansion: High dose of VB10.16 + Pembrolizumab The highest dose of VB10.16 to be safety-cleared in the escalation phase will be given via i.m. needle-free injections in the deltoid muscles and quadriceps and/or gluteus muscle
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
Experimental: Phase 2: Dose Expansion: 3 mg VB10.16 + Pembrolizumab 3 mg of VB10.16 via i.m. needle-free injections in the deltoid muscles
Pembrolizumab will be given as standard of care/ background medication via i.v. infusions
VB10.16: Intramuscular (i.m.) administrations of VB10.16 every 3 weeks (Q3W) starting at Week 1/Day 1 during a 12-week induction period, followed by a maintenance period with administrations every 6 weeks (Q6W) from Week 13 until Week 48. A total of up to 10 i.m. administrations will be given.
VB10.16 will be administered via Pharma Jet® Stratis 0.5 mL needle free injection system.
Pembrolizumab (KEYTRUDA®): Pembrolizumab 200 mg intravenous (i.v.) will be given in accordance with the local regulatory-approved label Q3W starting at Week 1/Day 1 for as long as the patient tolerates and continues to have clinical benefit from the treatment based on the patient and investigator's decision, up to a maximum of 35 treatments corresponding to approximately 2 years of treatment.
After 48 weeks of treatment patients can continue on 200 mg Q3W or change to 400 mg Q6W at the discretion of the investigator and after consultation with the sponsor.
Pembrolizumab will be given by i.v. infusion over 30 minutes.
Quelle: ClinicalTrials.gov
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"Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma"
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