Unresectable recurrent or metastatic HPV16 (Human Papilloma Virus) positive oropharyngeal Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
Escalation phase: Proportion of patients with DLTs (within 42 days), Expansion phase: Proportion of patients who discontinue due to an adverse reaction, Expansion phase: Objective response rate (ORR), Expansion phase: Change from baseline in HPV16 E6/E7-specific T-cell responses as measured by IFN-γ ELISpot in post-vaccination samples, Expansion phase: Proportion of patients with AEs following treatment initiation by severity grade., Full trial: Objective Response Rate (ORR)
Detailed description
Expansion phase: Disease control rate (DCR), Expansion phase: Duration of response (DOR), Expansion phase: Duration of complete response (DOCR), Expansion phase: Duration of disease control (DODC), Expansion phase: Time to response (TTR), Expansion phase: Progression-free survival (PFS), Expansion phase: Overall survival (OS), Expansion phase: Proportion of patients who are progression-free, Expansion phase: Proportion of patients who are alive, Full trial: Proportion of patients with AEs following treatment initiation by severity grade, Full trial: Proportion of patients who discontinue due to an adverse reaction, Full trial: Duration of response (DOR), Full trial: Proportion of patients who are alive, Full trial: Progression-free survival (PFS), Full trial: Overall survival (OS), Full trial: Proportion of patients who are progression-free, Full trial: Change from baseline in HPV16 E6/E7-specific T-cell responses as measured by IFN-γ ELISpot in post-vaccination samples
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Nykode Therapeutics ASA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Escalation phase: Proportion of patients with DLTs (within 42 days), Expansion phase: Proportion of patients who discontinue due to an adverse reaction, Expansion phase: Objective response rate (ORR), Expansion phase: Change from baseline in HPV16 E6/E7-specific T-cell responses as measured by IFN-γ ELISpot in post-vaccination samples, Expansion phase: Proportion of patients with AEs following treatment initiation by severity grade., Full trial: Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Expansion phase: Disease control rate (DCR), Expansion phase: Duration of response (DOR), Expansion phase: Duration of complete response (DOCR), Expansion phase: Duration of disease control (DODC), Expansion phase: Time to response (TTR), Expansion phase: Progression-free survival (PFS), Expansion phase: Overall survival (OS), Expansion phase: Proportion of patients who are progression-free, Expansion phase: Proportion of patients who are alive, Full trial: Proportion of patients with AEs following treatment initiation by severity grade, Full trial: Proportion of patients who discontinue due to an adverse reaction, Full trial: Duration of response (DOR), Full trial: Proportion of patients who are alive, Full trial: Progression-free survival (PFS), Full trial: Overall survival (OS), Full trial: Proportion of patients who are progression-free, Full trial: Change from baseline in HPV16 E6/E7-specific T-cell responses as measured by IFN-γ ELISpot in post-vaccination samples | — |
Countries
Czechia, France, Germany, Hungary, Norway, Poland, Spain
Outcome results
None listed