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PD-1 Inhibitor
Cemiplimab + ISA101b for Head and Neck Cancer
Phase 2
Waitlist Available
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 performance status of 0 or 1
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20-25 monhts
Awards & highlights
Study Summary
This trial will test a new combination of drugs to see if they are effective in treating cancer.
Who is the study for?
This trial is for adults with recurrent or metastatic HPV16 positive OPC who have previously received specific doses of anti-PD-1 antibodies. They must have measurable lesions, confirmed HPV16 positivity, and an ECOG performance status of 0 or 1. Excluded are those with significant autoimmune diseases, interstitial lung disease, recent major surgery, brain tumors/CNS issues, or additional cancer treatments after anti-PD-1 progression.Check my eligibility
What is being tested?
The study tests the combination of ISA101b and cemiplimab in patients with HPV16 positive OPC. It's a phase II open-label trial where all participants receive both drugs to evaluate their effectiveness and safety in treating this type of cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to cemiplimab (such as inflammation in organs), injection site reactions from ISA101b vaccine administration, fatigue, skin conditions like rash or itching, and possibly flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is HPV16 positive and has returned or spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20-25 monhts
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20-25 monhts
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate based on radiographic response
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
1Treatment groups
Experimental Treatment
Group I: single armExperimental Treatment1 Intervention
ISA101b 4 times plus cemiplimab every 3 weeks for up to 24 months
Find a Location
Who is running the clinical trial?
ISA PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
362 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,782 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had specific doses of cancer treatment for HPV16+ throat cancer and my last treatment was within 6 months.I have not had major surgery within the last 4 weeks.I have an untreated brain tumor or cancer that has spread to my brain or spinal cord.I haven't had brain inflammation, serious brain disorders, or uncontrolled seizures in the last year.I am fully active or restricted in physically strenuous activity but can do light work.I am 18 years old or older.I have at least one tumor that can be measured on a scan.I have not had treatment for advanced non-small cell lung cancer.I have not had lung inflammation or disease, except for radiation-related, in the last 5 years.My cancer is HPV16 positive, confirmed by a lab test.I stopped taking cancer immune therapies because of side effects.I have an autoimmune disease treated with immunosuppressants in the last 5 years, except for vitiligo, resolved childhood asthma, hormone-treated endocrinopathies, or psoriasis not needing systemic treatment.My cancer is HPV16 positive and has returned or spread.
Research Study Groups:
This trial has the following groups:- Group 1: single arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Which locations are hosting this research experiment?
"This research is being conducted at sites such as UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, California, H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida and Beth Israel Deaconess Medical Centre located in Boston, Massachusetts to name a few of the other 9 locations hosting this trial."
Answered by AI
Is this research program actively recruiting participants?
"Clinicaltrials.gov reveals that this medical study is actively seeking participants, with the initial posting having been on July 1st 2021 and its most recent update occurring October 11th 2022."
Answered by AI
Are there any prior examinations of the efficacy of ISA101B?
"Initial studies of ISA101B were conducted at City of Hope in 2010. Currently, there are 56 active trials and an additional 7 completed studies with many being undertaken from San Francisco, California."
Answered by AI
What pathological conditions can ISA101B be employed to combat?
"ISA101B can be employed to treat alk gene mutations, provide advanced directives, and combat malignant neoplasms."
Answered by AI
What risk factors should be considered with regards to the administration of ISA101B?
"ISA101B is ranked a 2 on the safety scale as this Phase 2 trial has demonstrated some evidence of safety, yet no definitive proof that it exhibits efficacy."
Answered by AI
What is the approximate headcount for participants in this medical experiment?
"Affirmative. According to clinicaltrials.gov, this investigation is in the process of finding suitable candidates and has been since July 1st 2021 when it was initially posted. The study needs 86 volunteers from 9 distinct medical sites and its latest update was on October 11th 2022."
Answered by AI
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