Phase Ib and Phase II part 1: HPV-16 positive recurrent or metastatic malignancies including oropharyngeal squamous cell carcinoma of head and neck, cervical cancer, vulvar cancer, vaginal cancer, penile cancer, anal cancer Phase II part 2: HPV-16 positive recurrent or metastatic malignancies including cervical cancer, anal cancer
Conditions
Brief summary
Phase Ib: safety and tolerability, Phase II part 1: overall response rate according to RECIST 1.1, Phase II part 2: progression-free survival according to RECIST 1.1
Detailed description
Phase Ib: Overall response rate by using RECIST 1.1 and overall safety profile, Phase Ib and phase II part 2: Overall response rate by using RECIST 1.1, Phase Ib and phase II part 1: Progression Free Survival (PFS), Overall Survival (OS), Duration of Response (DoR), Overall safety profile, Percentage of patients with liver metastases at baseline who have disease progression at D43 (phase II part 2)
Interventions
Sponsors
Transgene
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase Ib: safety and tolerability, Phase II part 1: overall response rate according to RECIST 1.1, Phase II part 2: progression-free survival according to RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase Ib: Overall response rate by using RECIST 1.1 and overall safety profile, Phase Ib and phase II part 2: Overall response rate by using RECIST 1.1, Phase Ib and phase II part 1: Progression Free Survival (PFS), Overall Survival (OS), Duration of Response (DoR), Overall safety profile, Percentage of patients with liver metastases at baseline who have disease progression at D43 (phase II part 2) | — |
Countries
France, Spain
Outcome results
None listed