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Alkylating agents
HPV Vaccine + Pembrolizumab + Cisplatin for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Robert L Ferris, MD, PhD
Research Sponsored by Dan Zandberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
N2c/N3 disease irrespective of tobacco exposure
T4 or N2c/N3 disease irrespective of tobacco exposure
Must not have
Received prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of a cancer vaccine, an immune-boosting drug, and standard treatments in adults with a specific type of head and neck cancer linked to HPV. The goal is to see if this combination improves patient survival.
Who is the study for?
This trial is for adults with newly diagnosed, intermediate risk HPV-16-associated head and neck squamous cell carcinoma without distant metastasis. Eligible patients must have a specific type of tumor in the oropharynx or unknown primary site, meet certain disease stage criteria, not have had prior treatments for head and neck cancer, be free from other cancers for at least 2 years (with some exceptions), and show adequate organ function.
What is being tested?
The study tests a new treatment combo: pembrolizumab (an immune therapy), ISA101b (HPV-16 vaccine), cisplatin (chemotherapy), and IMRT (targeted radiotherapy). It's designed to see if this mix can better treat local-regionally advanced head and neck cancer linked to HPV-16 compared to current standards.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from pembrolizumab or ISA101b, chemotherapy-induced nausea/vomiting from cisplatin, skin irritation from IMRT, fatigue, blood disorders that may increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to lymph nodes, regardless of my smoking history.
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My cancer is advanced, regardless of my smoking history.
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My cancer is p16 positive and HPV positive but its primary location is unknown.
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My cancer is at a stage where surgery cannot cure it.
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I had a second head/neck cancer more than 2 years after the first, treated with surgery only, and it hasn't come back.
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I have not had radiation therapy above my collarbone.
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I have a history of significant smoking and advanced lymph node involvement.
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I am fully active or can carry out light work.
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I haven't had chemotherapy, targeted therapy, or radiation for head and neck cancer.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.
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I have been treated with specific immune system targeting drugs before.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have serious lung conditions, including high blood pressure in my lungs or lung inflammation that needed steroids.
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I haven't taken antibiotics or antifungals for an infection in the last 7 days.
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I have an autoimmune disease that needed treatment in the last 3 months.
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I have a serious heart condition.
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My cancer originates in the mouth, voice box, lower throat, or upper throat.
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I have AIDS.
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I have been treated with anti-HPV drugs, not including vaccines.
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My cancer has not spread to distant parts of my body, including the brain.
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I have no severe allergies to medications or their ingredients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival (PFS) at 2 years
Secondary study objectives
Adverse Events Related to Study Treatment
Overall Survival (OS)
Progression-free Survival (PFS)
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMRT + Pembrolizumab + Cisplatin + ISA101bExperimental Treatment4 Interventions
IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week).
Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT.
Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3).
ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
ISA101b
2021
Completed Phase 2
~120
Cisplatin
2013
Completed Phase 3
~3120
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to recognize and attack cancer cells by blocking the PD-1 pathway. ISA101b, an HPV-16 E6/E7 specific therapeutic vaccine, stimulates the immune system to target and destroy cells expressing these viral proteins.
Cisplatin-based chemoradiotherapy combines cisplatin, which causes DNA damage in cancer cells, with radiation therapy to further inhibit the cancer cells' ability to repair, leading to cell death. These treatments are significant for Squamous Cell Carcinoma patients as they provide targeted and effective strategies to combat the cancer, potentially improving outcomes and survival rates.
Novel immune-modulating drugs for advanced head and neck cancer.The forgotten woman's cancer: vulvar squamous cell carcinoma (VSCC) and a targeted approach to therapy.The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.
Novel immune-modulating drugs for advanced head and neck cancer.The forgotten woman's cancer: vulvar squamous cell carcinoma (VSCC) and a targeted approach to therapy.The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.
Find a Location
Who is running the clinical trial?
Dan ZandbergLead Sponsor
6 Previous Clinical Trials
318 Total Patients Enrolled
Robert FerrisLead Sponsor
6 Previous Clinical Trials
225 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,783 Total Patients Enrolled
ISA PharmaceuticalsIndustry Sponsor
4 Previous Clinical Trials
377 Total Patients Enrolled
Robert L Ferris, MD, PhDPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled
Dan P Zandberg, MDPrincipal InvestigatorUPMC Hillman Cancer Center
3 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I haven't had monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I have been treated with specific immune system targeting drugs before.I have moderate to severe numbness, tingling, or pain in my hands or feet.My condition is considered to be at an intermediate risk level.My throat cancer is HPV positive and I have a history of significant tobacco use.I have serious lung conditions, including high blood pressure in my lungs or lung inflammation that needed steroids.I agree to have a required biopsy before treatment starts and may agree to two more during treatment.My cancer has spread to lymph nodes, regardless of my smoking history.My cancer is advanced, regardless of my smoking history.My cancer is p16 positive and HPV positive but its primary location is unknown.My cancer is at a stage where surgery cannot cure it.I haven't taken antibiotics or antifungals for an infection in the last 7 days.I had a second head/neck cancer more than 2 years after the first, treated with surgery only, and it hasn't come back.I have not had radiation therapy above my collarbone.My electrolyte levels are stable or have been corrected.I have an autoimmune disease that needed treatment in the last 3 months.I have been cancer-free for at least 2 years, except for any completely removed and cured cancers.I have not had major surgery in the last 6 weeks or have fully recovered if I did.I haven't had any cancer except for certain skin, breast, cervix, bladder, or prostate cancers in the last 2 years.I do not have multiple primary cancers, except for certain HPV+ throat cancers or small, non-spreading thyroid cancer.I have a serious heart condition.I have a history of significant smoking and advanced lymph node involvement.My cancer originates in the mouth, voice box, lower throat, or upper throat.My cancer is a type of throat cancer that hasn't spread far and started in the oropharynx.I am fully active or can carry out light work.I haven't had chemotherapy, targeted therapy, or radiation for head and neck cancer.I had chemotherapy or radiation for another cancer type, but it was over 2 years ago.I have AIDS.I have been treated with anti-HPV drugs, not including vaccines.I am 18 years old or older.My cancer has not spread to distant parts of my body, including the brain.I have no severe allergies to medications or their ingredients.I've had a tonsillectomy but still have measurable nodal disease.I have not had any major blood clots in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: IMRT + Pembrolizumab + Cisplatin + ISA101b
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.