A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC
NCT ID: NCT03669718
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
194 participants
INTERVENTIONAL
2018-11-30
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active ISA101b and cemiplimab.
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
ISA101b
Every 3 weeks for a total of 3 times
Cemiplimab
Every 3 weeks for up to 24 months
Placebo and cemiplimab
Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months
Cemiplimab
Every 3 weeks for up to 24 months
Placebo
Every 3 weeks for a total of 3 times
Interventions
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ISA101b
Every 3 weeks for a total of 3 times
Cemiplimab
Every 3 weeks for up to 24 months
Placebo
Every 3 weeks for a total of 3 times
Eligibility Criteria
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Inclusion Criteria
* Sign and date an Institutional Review Board/Independent Ethics Committee (IRB)/(IEC)-approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
* Be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
* Diagnosed with histologically confirmed recurrent or metastatic HPV16 positive OPC, whose tumors express PD-L1 (Combined Positive Score \[CPS\] ≥1) and who are candidates for first line therapy with an PD-1 blocking antibody, AND subjects with recurrent or metastatic HPV16 positive OPC with disease progression on or after platinum containing chemotherapy.
* HPV-16 genotyping will be determined by the specified central reference laboratory.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
* Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration.
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of study drug.
Exclusion Criteria
* Subjects with known brain metastases or leptomeningeal metastases.
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
* History of other malignancy ≤ 3 years prior to entry into this trial with the exception of basal cell or squamous cell skin carcinoma which were treated with local resection only, or carcinoma in situ of the cervix, prostate or breast, or low grade non-muscle invasive superficial bladder cancer (TaLG)/carcinoma in situ of the bladder.
* Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* Subjects with a condition requiring immunosuppressive doses of systemic medication such as steroids or absorbed topical steroids (doses ≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* Prior treatment with an anti-PD-1 antibody (e.g., nivolumab, pembrolizumab, cemiplimab), as well as an antibody targeting anti-PL-L1 anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co stimulation or immune checkpoint pathways.
* Prior treatment with more than one chemotherapy regimen for the management of metastatic OPC.
* Prior treatment with therapeutic anti-HPV vaccines including ISA101 or ISA101b. Subjects may have received a preventive HPV vaccine.
* All toxicities attributed to systemic prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE) or baseline before administration of study drug. Subjects with toxicities attributed to systemic prior anticancer therapy that are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll.
* History of allergy to ISA101/ISA101b study drug components, e.g., ISA101/101b, Montanide, or Macrogolglycerol Ricinoleate, also known as cremophore.
* History of allergy to cemiplimab and its excipients.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
ISA Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Bonnie S. Glisson, MD, BS
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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City of Hope
Duarte, California, United States
Moores Cancer Center at the UC San Diego Health
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
M. D. Anderson Cancer Center
Houston, Texas, United States
University Hospital Antwerp
Antwerp, , Belgium
DFSATR/Oncologia D'Or
Brasília, , Brazil
Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
University Hospital Olomouc
Olomouc, , Czechia
Nemocnice na Bulovce
Prague, , Czechia
Centre Léon Bérard
Lyon, , France
CHU La Timone
Marseille, , France
Antoine Lacassagne Center
Nice, , France
Gustave Roussy
Paris, , France
Hopitaux Universitaires Pitié Salpêtrière Charles Foix
Paris, , France
Universitaetsklinikum Ulm
Ulm, , Germany
Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
University of Pecs Department of Oncotherapy
Pécs, , Hungary
Hetenyi Geza Korhaz-Rendelointezet
Szolnok, , Hungary
ASST Spedali Civili Brescia, Department of Medical Oncology
Brescia, , Italy
Azienda Ospedaliera San Paolo Polo Universitario
Milan, , Italy
Istituto Nazionale dei Tumori
Milan, , Italy
National Cancer Institute - IRCCS "Fondazione G. Pascale"
Naples, , Italy
National Cancer Institute Regina Elena, IRCCS
Rome, , Italy
Consultorio de Oncología Médica
Oaxaca City, , Mexico
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Maria Sklodowska-Curie National Institute of Oncology
Gliwice, , Poland
Swietokrzyskie Oncology Center Kielce
Kielce, , Poland
Hospital Clinic of Barcelona
Barcelona, , Spain
Hospital Duran i Reynals - Institut Catala dOncologia ICO
Barcelona, , Spain
Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Marqués de Valdecilla Santander
Santander, , Spain
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
The Royal Marsden NHS Foundation
Chelsea, , United Kingdom
Guy's Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Beacon Centre Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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Even C, Harrington KJ, Massarelli E, Laban S, Fayette J, Oliva M, Klein Hesselink M, Visscher S, Fury MG, Wiekmeijer AS, Licitra L, Melichar B, Devriese LA, Brana I, Jankowska P, Posner M, Glisson B, Kong A, Hooftman L, Melief CJM MD,, Ferrarotto R. Randomized clinical efficacy and safety study of peltopepimut-S plus cemiplimab compared to cemiplimab alone in patients with recurrent/metastatic HPV16-positive head and neck cancer. J Immunother Cancer. 2025 Sep 8;13(9):e012555. doi: 10.1136/jitc-2025-012555.
Other Identifiers
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ISA101b-HN-01-17
Identifier Type: -
Identifier Source: org_study_id