Squamous Cell Carcinoma of the OropharynxPhase 2NCT04398524
A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC
A Phase 2 study testing ISA101b in people with Squamous Cell Carcinoma of the Oropharynx, run by ISA Pharmaceuticals at 41 sites in 9 countries.
Trial summary
This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oropharynx
- What is being tested?
- ISA101b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 41 sitesin 9 countries
- Study dates
- 1 Jul 2021to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- Provide informed consent signed by study patient.
- 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 genotyping as determined by a specified central reference laboratory. If local specific HPV16 genotype assessment has been performed, the patient can be enrolled if the result shows HPV16 positivity. Confirmation of HPV16 positive status will then subsequently have to be performed by the central laboratory.
- Patients who have received a minimum total dose of 600 mg of pembrolizumab or 960 mg of nivolumab or equivalent anti-PD-1 antibody with or without chemotherapy for only 1st or 2nd line recurrent/ 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), and anti PD-1 therapy (as 1st or 2nd line for recurrent/metastatic HPV16 positive OPC) should have been the last treatment regimen that the patient received before entry into the current trial.
- 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.
Who cannot join
- Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia and hospital admission) within 4 weeks prior to start of study treatment.
- Patients who, after progressing on anti-PD-1, received additional anti-cancer therapy (chemotherapy, radiotherapy, experimental TKI's, immunotherapy, anti-EGFR antibodies, surgery). The following palliative treatments are allowed:
- palliative radiotherapy (but NOT for target lesions)
- palliative surgery
- bone resorptive therapy such as bisphosphonates and denosumab but only if patients have been on stable doses for > 4 weeks prior to first dose of test treatment
- Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
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- 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.
Trial locations and contacts
41 sites in 9 countries.
41 sites in 9 countries
United States8 sites
Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Cancer Institute
Buffalo, New York, 14263
City of Hope National Medical Center
Duarte, California, 91010
Providence Portland Medical Center
Portland, Oregon, 97213
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Washington University
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
France7 sites
Saint Andre Hospital, Department of Oncology
Bordeaux, 33000
Leon Berard Center, Department of Medical Oncology
Lyon, 69008
CHU La Timone - La Timone Children's Hospital
Marseille
Georges Pompidou European Hospital
Paris
Jean Godinot Institute, Cancer Research Center
Reims
Paul Strauss Center
Strasbourg
Gustave Roussy Institute
Villejuif
Germany5 sites
University Hospital Cologne, Department of Otorhinolaryngology (ENT)
Cologne, 50937
University Hospital Giessen and Marburg GmbH
Giessen
University Hospital Mannheim
Mannheim
Caritas Klinikum
Saarbrücken
University Hospital Ulm
Ulm
Italy5 sites
Università degli Studi di Brescia
Brescia
European Institute of Oncology (IEO), IRCCS, Department of Otolaryngology and Facial Cervix Surgery
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
National Cancer Institute - IRCCS
Naples
Institute of Cancer Research and Treatment of Candiolo
Turin, 10060
Spain5 sites
Hospital Clinic of Barcelona
Barcelona
University Hospital Vall d'Hebron
Barcelona
Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Oncology
L'Hospitalet de Llobregat, 08908
University Clinic of Navarra - Madrid
Madrid, 28027
University Clinic of Navarra
Pamplona, 31008
Belgium3 sites
University Hospital Antwerp
Antwerp
University Hospital Ghent
Ghent
Centre Hospitalier Universitaire de Liege
Liège, 4000
Czechia3 sites
Clinic of Oncology
Olomouc
Institute of Radiation Oncology
Prague
University Hospital Motol, Clinic of Oncology
Prague
United Kingdom3 sites
Guy's Hospital
London
Royal Marsden Hospital
London
Royal Marsden Hospital - Sutton
Sutton
Israel2 sites
Hadassah Medical Center
Jerusalem
The Tel Aviv Sourasky Medical Cente
Tel Aviv
About this study
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
This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.
Read the 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.
- Being tested
- ISA101b
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISA101bDrug
Also called Cemiplimab
ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months Receives: Drug: ISA101b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate based on radiographic response
Measured by RECIST version 1.1.
Measured: 20-25 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jul 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the OropharynxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISA Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398524
- Sponsor's protocol ID
- ISA101b-OPC-03-19
- Status last verified
- Jan 2024
- First submitted
- 18 May 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04398524
- Acronym / sponsor ID
- ISA101b-OPC-03-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- ISA PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: ISA101bISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women ≥ 18 years of age.
- Provide informed consent signed by study patient.
- 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 genotyping as determined by a specified central reference laboratory. If local specific HPV16 genotype assessment has been performed, the patient can be enrolled if the result shows HPV16 positivity. Confirmation of HPV16 positive status will then subsequently have to be performed by the central laboratory.
Key exclusion criteria (10 listed)
- Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia and hospital admission) within 4 weeks prior to start of study treatment.
- Patients who, after progressing on anti-PD-1, received additional anti-cancer therapy (chemotherapy, radiotherapy, experimental TKI's, immunotherapy, anti-EGFR antibodies, surgery). The following palliative treatments are allowed:
- palliative radiotherapy (but NOT for target lesions)
- palliative surgery
- bone resorptive therapy such as bisphosphonates and denosumab but only if patients have been on stable doses for > 4 weeks prior to first dose of test treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISA101bAlso: CemiplimabISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months | Drug | single arm |
Primary outcome
Objective Response Rate based on radiographic response
Time frame: 20-25 monhts
Measured by RECIST version 1.1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISA101b in people with Squamous Cell Carcinoma of the Oropharynx, run by ISA Pharmaceuticals at 41 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, France, Germany, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate based on radiographic response (time frame: 20-25 monhts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.