This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized Phase of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy to generate pivotal efficacy and safety data in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Randomization will be stratified by PDL1 CPS <20 vs PD-L1 CPS ≥20, and prior chemotherapy (yes vs no). Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 in combination with pembrolizumab) within Part A.
A clinical trial investigating BNT113 in combination with pembrolizumab versus pembrolizumab alone for patients with a form of head and neck cancer positive for human papilloma virus 16 and expressing the protein PD-L1
An open-label Phase II randomized trial of BNT113 in combination with
pembrolizumab versus pembrolizumab monotherapy as a first line therapy in
patients with unresectable recurrent, or metastatic Head and Neck
Squamous Cell Carcinoma (HNSCC) which is positive for human papilloma
virus 16 (HPV16+) and expresses PD-L1
pembrolizumab versus pembrolizumab monotherapy as a first line therapy in
patients with unresectable recurrent, or metastatic Head and Neck
Squamous Cell Carcinoma (HNSCC) which is positive for human papilloma
virus 16 (HPV16+) and expresses PD-L1
Head and neck cancer
All genders
18+
Recruiting now
Overview
Principal Investigator: Yu Cao, MD
Contact Us
Latoya Marshall
Study details
Inclusion Criteria
- 1. Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies. HPV16 positivity is confirmed by central testing.
- 2. Patients who have a tumor that expresses PD-L1 [CPS ≥1] as determined by the approved test PD-L1 immunohistochemistry (IHC) 22C3 pharmDx kit performed and evaluated according to the manufacturer’s specifications and relevant regulatory approvals.
- 3. Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.
Exclusion Criteria
- 1. Patients present primary tumor site of nasopharynx (any histology).
- 2. Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, noninvasive superficial bladder cancer or breast ductal carcinoma in situ).
- 3. Patients who have received or currently receive the following therapy/medication:
− Chronic systemic immunosuppressive treatment including corticosteroid treatment in the 7 d prior to the first dose of trial treatment.
− Prior treatment with other immune-modulating agents
− Prior treatment with other immune-modulating agents for any non-cancer disease with toxicities that have not resolved before the first dose of BNT113.
Study Requirements
There will be a Safety Run-In Phase (Part A) followed by the Randomized Phase (Part B). The planned trial duration is: • Approximately up to 65 months of recruitment (in total, for Part A and Part B). • Approximately up to 24 months of treatment with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy. • 90 days (d) of safety follow-up following last dose of trial treatment. • Approximately (at least) 24 months OS follow-up from the last patient’s first dose of BNT113.