The information contained on this page is intended only for healthcare providers practicing in the United States.

Now Enrolling:

Immuno-oncology clinical study for patients
with head and neck squamous cell carcinoma (HNSCC HPV16+/PD-L1+)
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The AHEAD-MERIT study is evaluating BNT113, an RNA-based investigational therapeutic cancer vaccine, for patients with HNSCC that are positive for human papilloma virus 16 (HPV16+) and programmed death ligand 1 (PD-L1).

BNT113:

Is designed to be a ribonucleic acid-lipoplex (RNA-LPX) vaccine

Is intended to target HPV16 oncoproteins E6 and E7

Will be administered in combination with pembrolizumab versus pembrolizumab monotherapy in the AHEAD-MERIT study

Download the
Patient Brochure

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Brochure

Who can participate in this study?

Patients who meet the following criteria may qualify.

18 years+ with unresectable recurrent or metastatic HPV16+ HNSCC

Have histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies

Have a tumor located in the oropharynx, oral cavity, hypopharynx, and/or larynx that expresses programmed death ligand 1 (PD-L1)
This is not a full list of criteria. Please refer to Clinicaltrials.gov (NCT04534205) for more eligibility requirements.

Study Summary

Medicine
Study Treatment:
1:1 randomization with pembrolizumab or pembrolizumab +BNT113
People
Participant Details:
18 years+ with unresectable
recurrent or metastatic
HPV16+ HNSCC
Sponsor
Sponsor
BioNTech
Calendar
Trial Status:
Currently Enrolling

Study Site Locations

Click on the map below to see study site locations near you.
Location
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Winship Cancer Institute
550 Peachtree St. NE
Atlanta, GA 30308
Allyson Anderson, allyson.anderson@emory.edu, (404) 686-0239
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Montefiore Medical Center
3400 Bainbridge Ave # 8
Bronx, NY 10467
Kifyat Mohammad, mkifyat@montefiore.org, (718) 405-8539
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Norton Cancer Institute
Downtown, Norton Healthcare 234 E. Gray Street
Louisville, KY 40202
Jaspreet Grewal, Jaspreet.Grewal@nortonhealthcare.org, (502) 394-6350
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Providence Medical Center
Franz Clinic, 4805 NE Glisan Street, Suite 6N40
Portland, OR 97213
Rom Leidner, Rom.Leidner@providence.org, (503) 215-5696
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Yale Cancer Institute
Yale Cancer Center, Clinical Trials Office 2 Church Street South, Suite 507
New Haven, CT 06519
Stacy Severin, stacy.severin@yale.edu, (402) 501-8654
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California Research Institute (CRI)
1300 N Vermont Ave
Los Angeles, CA 90027-6005
Clare Gregorio, cg@caresinst.com, (818) 572-6696
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MultiCare Regional Cancer Center
1003 South 5th Street
Tacoma, WA 98405
Stacey Macon, smmacon@multicare.org, (253) 403-0791
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University of Miami Health System
Clinical Research Services (CRS) Sylvester Comprehensive Cancer Center, 8100 Sw 10th St, Ste 2600
Plantation, FL 33324-3274
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Tufts Medical Center
800 Washington St
Boston, MA 2111
Anicka Samuel, asamuel@tuftsmedicalcenter.org, (617) 636-8885
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University of New Mexico Comprehensive Cancer Center
1201 Camino de Salud
Albuquerque, NM 87131
Jerry Rodriguez, jerrodriguez@salud.unm.edu, (505) 263-7688
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University of Cincinnati Cancer Center
Tisch Cancer Institute 202 E 96th Street
NY, NY 10128
Virani Vruti, vruti.virani@mssm.edu, (212) 824-7860
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George Washington Cancer Center (GWCC)
800 22nd Street, NW
Washington, DC 20052
Ciara Avelina Lugo, ciara.lugo@email.gwu.edu, (202) 994-1179
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UCLA Cancer Care
100 UCLA Medical Plz: Suite 550
Los Angeles, CA 90024
Deborah Wong, dewong@mednet.ucla.edu, (310) 325-8252
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University of Cincinnati Cancer Center
3188 Bellvue Ave
Cincinnati, OH 45219
Christopher Lemmon, Lemmoncr@ucmail.uc.edu, 513 558 2826
Click to copy and paste nearby study site locations into your patient notes.
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