oropharynx 3D rendering illustration © Matthieu - stock.adobe.com
About the Phase 1/2a Trial of CD40HVac
Trial Name: Multicentric Randomized Phase I/IIa Trial of the Safety and Immunogenicity of a Therapeutic Anti-HPV DC Targeting Vaccine in Patients With Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer
ClinicalTrials.gov Identifier: NCT06007092
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Recruitment Contact: Philippe GORPHE, PhD, +33(0)142114211, firstname.lastname@example.org or Caroline EVEN, MD, 33(0)142114211, Caroline.email@example.com
Completion Date: August 2026
The first patient with HPV-positive oropharyngeal cancer has been treated with CD40HVac, a new therapeutic vaccine candidate for HPV-associated malignancies, in a phase 1/2a trial (NCT06007092).1
“The CD40HVac therapeutic vaccine candidate will provide a promising addition to the existing therapeutic arsenal, once its benefit and safety have been demonstrated in patients with HPV-positive oropharyngeal cancer. We are delighted to be conducting this study,” said Caroline Even, MD, head of the Head and Neck Medical Oncology Unit at Gustave Roussy, in a press release.
CD40HVac is a vaccine that is based on an innovative technology which targets dendritic cells directly. These cells play a key role in the immune system through the stimulation and regulation of immune responses.
In a recent study with a United States population conducted by the Centers for Disease Control and Prevention, findings showed that 66% of cervical cancers, 55% of vaginal cancers, 79% of anal cancers, and 62% of oropharyngeal cancers are attributable to HPV 16 and 18. Therefore, HPV-induced tumors require new treatment options which can help provide better efficacy and outcomes to patients.
Within the phase 1/2a study sponsored by Gustave Roussy, the immunogenicity and safety of CD40HVac will be evaluated when given with the Poly-ICLC adjuvant (Hiltonol) for patients with HPV-positive oropharyngeal cancer. The study will also determine the recommended dose for the phase 2 study (RP2D) as a primary end point. This will be determined based on the safety profile of the vaccine and its ability to generate immune responses.
The multicenter, double-blind, placebo-controlled, dose-escalation trial plans to test 2 doses (1 mg or 3 mg) of CD40HVac using a dose-escalation regimen in up to 24 patients.2
Patients aged 18 years and older with histologically confirmed oropharyngeal squamous cell carcinoma who are HPV16-positive are eligible to enroll in the study if they have an ECOG performance status of 0-1, no evidence of residual or recurrent disease, and comprehensive curative treatment that has been completed at least 18 weeks prior to the administration of treatment. Patients must have also received their vaccinations for Covid and the Flu 4 weeks before or after the administration of poly-ICLC-adjuvanted CD40Hvac and have laboratory values that meet the necessary criteria that are also obtained within 14 days prior to randomization.
In addition to the primary end points of the frequency of HPV16-specific T cells and RP2D, investigators will assess exploratory objectives, including progression-free survival and overall survival.
"This first administration is a major milestone in the development of our therapeutic cancer vaccine CD40HVac. Our teams are committed to uniting their efforts to bring significant innovations to patients with limited therapeutic options, particularly those with recurrent and/or metastatic HPV-positive cancers,” said Valérie Bouchara, head of clinical operations at LinKinVax, in the press release.1
1. LinKinVax and Gustave Roussy announced first patient dosed in phase I/IIa clinical study on HPV.DCVax in HPV-positive oropharyngeal cancer. News release. LinKinVax. September 18, 2023. Accessed September 19, 2023. https://tinyurl.com/2hzncuy5
2. Therapeutic vaccine in patients with human papillomavirus HPV-positive oropharyngeal cancer. ClinicalTrials.gov. Updated August 23, 2023. Accessed September 19, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT06007092