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Trial record 1 of 1 for:    NCT04398524
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A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04398524
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : September 14, 2021
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
ISA Pharmaceuticals

Brief Summary:
This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Oropharynx Drug: ISA101B Phase 2

Detailed Description:
This study will assess the ability of ISA101b plus cemiplimab to improve Overall Response Rate in subjects who have progressed on prior anti-PD-1 therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients With Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer Who Have Experienced Disease Progression With Prior Anti-PD-1 Therapy
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : November 1, 2024

Arm Intervention/treatment
Experimental: single arm
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
Drug: ISA101B
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
Other Name: Cemiplimab

Primary Outcome Measures :
  1. Objective Response Rate based on radiographic response [ Time Frame: 20-25 monhts ]
    Measured by RECIST version 1.1.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Provide informed consent signed by study patient or legally acceptable representative.
  • Willing and able to comply with site visits and study-related procedures and requirements.
  • Histologically confirmed recurrent or metastatic HPV16 positive OPC. Patients with squamous cell carcinoma of occult primary site, presenting with lymph node(s) limited only to the neck, are also eligible. Patients should have HPV16 positivity confirmed before being considered a candidate for this study.
  • HPV16 positive disease as determined by a specified central reference laboratory investigational use only assay.
  • Patients who have received a minimum of 4 doses of pembrolizumab or nivolumab or equivalent anti-PD-1 antibody with or without chemotherapy for 1st or 2nd line metastatic HPV16 positive OPC. The last dose of anti-PD-1 must have been no more than 6 months prior to the first dose of study drug. Progressive disease (PD) must have been diagnosed during or after anti-PD-1 therapy (but not longer than 6 months after the last dose).
  • At least one measurable lesion by CT or MRI per RECIST version 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented disease progression in that site.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria:

  • Major surgery within 14 days of first administration of enrollment.
  • Radiation therapy after progression on prior anti-PD-1 antibody.
  • Any intervening anti-cancer therapy since last dose of anti-PD-1 including induction chemotherapy.
  • Patients who, after progressing on anti-PD-1, required subsequent chemotherapy within the last 4 weeks prior to enrollment in order to control disease.
  • Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
  • Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression.
  • Encephalitis, meningitis, organic brain disease (e.g. Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy.
  • Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (in the past 5 years). A history of radiation pneumonitis in the radiation field is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04398524

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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Erminia Massarelli, MD    626-256-4673      
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Douglas Adkins, MD    314-747-8475      
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Mathew Taylor, MD    503-215-5696      
United States, Texas
The University of Texas M. D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Bonnie Glisson, MD    713-792-6363      
University Hospital Ghent Recruiting
Ghent, Belgium
Contact: Sylvie Rottey, MD    +32(0)9 332 26 91   
Centre Hospitalier Universitaire de Liege Recruiting
Liège, Belgium, 4000
Contact: Brieuc Sautois, MD    +32 436 67 664      
Clinic of Oncology Recruiting
Olomouc, Czechia
Contact: Bohuslav Melichar, MD    00420 588 443 896      
Institute of Radiation Oncology Recruiting
Prague, Czechia
Contact: Petra Holeckova, MD    00420-266 084 212      
CHU La Timone - La Timone Children's Hospital Recruiting
Marseille, France
Contact: Sébastien Salas, MD    +33(0)491385708      
Jean Godinot Institute Recruiting
Reims, France
Contact: Alain Prevost, MD    +33 336504426      
Paul Strauss Center Recruiting
Strasbourg, France
Contact: Christian Borel, MD    0033388252485      
Gustave Roussy Institute Recruiting
Villejuif, France
Contact: Caroline Even, MD    0033142115352      
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany
Contact: Claudia Chapuy, MD    0049 551 398943      
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy
Contact: Lisa Licitra, MD    +39 (2) 2390 2150      
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain
Contact: Neus Baste, MD    +34 93 227 54 00 ext 1493      
Sponsors and Collaborators
ISA Pharmaceuticals
Regeneron Pharmaceuticals
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Responsible Party: ISA Pharmaceuticals Identifier: NCT04398524    
Other Study ID Numbers: ISA101b-OPC-03-19
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents