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Compares treatment options for Unresectable Head and Neck Squamous Cell Carcinoma
Official title A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of 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
ClinicalTrials.gov ID: NCT04534205
What this study is testing
What is BNT113?
BNT113 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.
- Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.
- Patients who have a tumor that expresses PD-L1 [CPS ≥1] as determined by the European Conformity (CE)-marked/Food and Drug Administration-approved...
- Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which...
- Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously...
You likely can't join if
- Medical conditions:
- Patients present primary tumor site of nasopharynx (any histology).
- 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...
- Patients who have received or currently receive the following therapy/medication:
- Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone \>10 mg daily orally [PO] or intravenously [IV], or...
- Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is...
See the full eligibility criteria
- Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.
- Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.
- Patients who have a tumor that expresses PD-L1 [CPS ≥1] as determined by the European Conformity (CE)-marked/Food and Drug Administration-approved CDx PD-L1 immunohistochemistry 22C3 pharmDx performed according to the...
- Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 180 days prior to randomization, if given as...
- Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been...
- All patients must provide a tumor tissue sample (formalin fixed paraffin embedded [FFPE] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy sample...
- Medical conditions:
- Patients present primary tumor site of nasopharynx (any histology).
- 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...
- Patients who have received or currently receive the following therapy/medication:
- Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone \>10 mg daily orally [PO] or intravenously [IV], or equivalent) in the 7 days prior to the first dose of trial treatment.
- Prior treatment with other immune-modulating agents that was (a) within fewer than 4 weeks (28 days) or five half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with...
- Prior treatment with live attenuated vaccines within 4 weeks before the first dose of BNT113.
- Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or five half-lives of the agent (whichever is longer) before the planned first dose of BNT113.
- Ongoing treatment with therapeutic PO or IV antibiotics. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) may be enrolled.
- Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic...
- Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization. Note: Prior treatment with bone resorptive therapy, such as bisphosphonates (e.g., pamidronate...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Albuquerque, New Mexico, United States
- Long Island City, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Tacoma, Washington, United States
- Berazategui, Argentina
- Ciudad de Buenos Aires, Argentina
- Córdoba, Argentina
+ 145 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Athens, Georgia, United States and 159 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.