Actively Recruiting
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-12-01
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
L
LinKinVax
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy. The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored * 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC * 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.
CONDITIONS
Official Title
Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Able and willing to follow scheduled visits, treatments, lab tests, and study requirements
- Histologically confirmed oropharyngeal squamous cell carcinoma
- HPV16 positive confirmed by central lab or local test
- ECOG performance status of 0 or 1
- Completed curative surgery and/or radiochemotherapy at least 16 weeks before study drug
- No residual or recurrent disease confirmed by physical exam and imaging
- Allowed COVID and flu vaccines 4 weeks before or after study vaccine (2 weeks during flu season for flu vaccine)
- Laboratory values within required ranges including blood counts, kidney and liver function
- Females of reproductive potential must have negative pregnancy tests and use effective contraception before and during study
- Males must use effective contraception if sexually active with female partners
- Able to understand and sign informed consent
- Affiliated with social security system or equivalent
You will not qualify if you...
- Residual or recurrent HPV-related cancer detected by exam or imaging
- Serious or uncontrolled medical conditions increasing study risk or interfering with treatment
- Active autoimmune diseases except certain mild conditions like vitiligo or controlled hypothyroidism
- Active interstitial lung disease or pneumonitis or immunosuppressive medication use within 14 days
- Maintenance treatment with immunosuppressive systemic corticosteroids
- Prior therapeutic anti-HPV vaccine treatment
- Surgery requiring general or spinal anesthesia within 28 days before study treatment
- Uncontrolled HIV, hepatitis B or C infection
- Active infections requiring treatment
- Significant heart disease or uncontrolled arrhythmias
- History of organ transplant
- Participation in another investigational study within past 6 months
- COVID or flu vaccination within 4 weeks before study vaccine (2 weeks for flu vaccine during flu season)
- Treatment with certain immunosuppressive drugs, corticosteroids, vaccines, blood products, or immunomodulators within specified timeframes
- Pregnant or breastfeeding women or planning pregnancy during study
- Individuals under guardianship or unable to consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94 805
Actively Recruiting
Research Team
P
Philippe GORPHE, PhD
CONTACT
C
Caroline EVEN, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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