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Checkpoint Inhibitor
Cemiplimab + ISA101b for HPV-Related Throat Cancer
Phase 2
Waitlist Available
Led By Bonnie S. Glisson, MD, BS
Research Sponsored by ISA Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25months
Awards & highlights
Study Summary
This trial will compare cemiplimab to cemiplimab plus ISA101b to see if the addition of ISA101b helps cemiplimab work better.
Who is the study for?
Adults diagnosed with HPV16 positive recurrent or metastatic OPC (a type of throat cancer), whose tumors express a protein called PD-L1 and are suitable for first-line therapy with PD-1 blocking antibodies, or have progressed after chemotherapy. Participants must be in good physical condition (ECOG 0-1) and not have used certain immunosuppressive drugs recently. Women must test negative for pregnancy.Check my eligibility
What is being tested?
This phase 2 trial is testing the effectiveness of Cemiplimab combined with ISA101b versus Cemiplimab with a placebo in treating HPV16-positive OPC. Patients will be randomly assigned to one of these two groups without knowing which treatment they receive.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the components of ISA101b or Cemiplimab, such as Montanide or cremophore, and typical immune-related adverse events from PD-1 inhibitors like skin reactions, hormonal changes, inflammation in organs, fatigue, and potential worsening of autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I have signed the consent form approved by the ethics committee.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 "Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0".
Overall Response Rate
Secondary outcome measures
Duration of response (DOR) by independent review in subjects randomized to receive ISA101b plus cemiplimab compared to placebo plus cemiplimab.
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active ISA101b and cemiplimab.Experimental Treatment2 Interventions
ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
Group II: Placebo and cemiplimabPlacebo Group2 Interventions
Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
ISA PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
233 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,653 Total Patients Enrolled
Bonnie S. Glisson, MD, BSPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
83 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have signed the consent form approved by the ethics committee.My cancer is HPV16 positive, expresses PD-L1, and has either not been treated or progressed after chemotherapy.You have had an allergic reaction to cemiplimab or any of its ingredients.I haven't taken high doses of steroids or other immune-weakening medicines in the last 14 days.I haven't had cancer, except for certain skin, cervix, prostate, breast, or bladder cancers in the last 3 years.I have brain or leptomeningeal metastases.I have not had HPV treatment vaccines but may have had the preventive vaccine.I am 18 years old or older.My cancer is HPV16 positive, expresses PD-L1, and has either not been treated or progressed after chemotherapy.My HPV-16 status will be tested by a specific lab.I am fully active or can carry out light work.My cancer is HPV16 positive, has not been treated, cannot be surgically removed, does not respond to PD-1 antibody treatments.All my side effects from previous cancer treatments, except hair loss and tiredness, are mild or gone.I am fully active or can carry out light work.I finished my curative radiation therapy at least 4 weeks ago, or my palliative radiation therapy at least 2 weeks ago.I have had more than one chemotherapy treatment for my advanced oral cancer.I have signed the consent form approved by the ethics committee.I have previously been treated with specific immune-targeting cancer drugs.My HPV-16 status will be tested by a specific lab.You are willing and able to comply with the study requirements.I am 18 years old or older.I have an autoimmune disease but it's under control or not expected to worsen.
Research Study Groups:
This trial has the following groups:- Group 1: Active ISA101b and cemiplimab.
- Group 2: Placebo and cemiplimab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity for this clinical experiment?
"To properly conduct this clinical trial, a total of 194 volunteers must be recruited who meet the inclusion criteria. Sponsored by Regeneron Pharmaceuticals, the trial will take place in multiple locations such as Washington University School of Medicine in Saint Louis, Missouri and University of California San Francisco in San Francisco, California."
Answered by AI
Is enrollment ongoing for this clinical survey?
"Affirmative. Clinicaltrials.gov's data confirms that this clinical trial is seeking enrolment and was posted on November 30th 2018 with the most recent edit occurring on September 25th 2022. A total of 194 patients are needed from 12 different sites for successful completion of the study."
Answered by AI
Has ISA101b been granted authorization by the FDA?
"Our team has determined the safety of ISA101b to be a 2, as there is evidence that suggest it holds up against potential harm but no data exists yet indicating its efficacy."
Answered by AI
How many medical centers are conducting this experiment?
"This research is being conducted at 15 medical centres across America, including Saint Louis, San Francisco and Sterling Heights. If a patient wishes to be part of this trial they should select the clinic in closest proximity to them so as to reduce their overall travel needs."
Answered by AI
Has ISA101b been the subject of any additional research protocols?
"ISA101b was first tested at City of Hope in the year 2010, with 18332 trials completed since then. As of now, 56 investigations are ongoing and many can be found close to Saint Louis, Missouri."
Answered by AI
What therapeutic benefit has ISA101b demonstrated?
"ISA101b is a viable option for treating alk gene mutation, creating and adhering to advance directives, and managing malignant neoplasms."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
M. D. Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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