Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. Within each group, patients will be randomized between poly-ICLC- adjuvanted CD40HVac or placebo in a 5:1 ratio. 12 patients will be treated at each dose level (10 with vaccine and 2 with placebo). The patients will receive three subcutaneous injections of a poly-ICLC- adjuvanted CD40HVac or placebo: - The first injection will occur at week 0 - The second injection will occur at week 4 (±7 days) - The third injection will occur at week 24 (±7 days) Within each dose group, a period of 7 days must be observed between the first administration of vaccine of the first patient of the group and the first administration of vaccine/placebo of the second patient of the group. A safety monitoring is planned in each dose level group: - If a grade 5 AE occurs (except if related to cancer) at any time, all vaccinations will be halted, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation - If a grade 4 AE related to vaccine occurs at any time, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation - If a grade 3 AE related to vaccine occurs at any time and does not resolve or decrease to grade 1 or baseline after 7 days, inclusions in the trial will be suspended and an IDSMB meeting convened for evaluation The IDSMB recommendations as to whether or not to continue the trial after its assessment of the AE will be transmitted to the Steering Committee and to the sponsor. Enrolment into the second dose group will open depending on the safety data of the first dose group during the safety observation period and after IDSMB and Steering Committee validation. For each patient, this safety observation period begins from the first administration and stops 2 weeks after the second injection, i.e. at Week 6. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06007092
Study type Interventional
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Philippe GORPHE, PhD
Phone +33 (0)1 42 11 42 11
Email philippe.gorphe@gustaveroussy.fr
Status Recruiting
Phase Phase 1/Phase 2
Start date July 31, 2023
Completion date August 2026

See also
  Status Clinical Trial Phase
Terminated NCT04110249 - Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Completed NCT03663985 - FALCOn (Facteur AnthropoLogique Cancer Orl)
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Recruiting NCT05077072 - Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients Phase 2
Recruiting NCT04151082 - High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors Phase 1/Phase 2
Completed NCT03964896 - Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy N/A
Recruiting NCT04147494 - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Early Phase 1
Completed NCT02474095 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer N/A
Withdrawn NCT03261180 - Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer N/A
Terminated NCT04618432 - Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Active, not recruiting NCT02615275 - Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy N/A
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Recruiting NCT04870762 - Customized 3D Printed Oral Stents During Head and Neck Radiotherapy Phase 2
Completed NCT02369835 - Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy Phase 3
Completed NCT03902535 - Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
Recruiting NCT05526924 - Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer Phase 1
Recruiting NCT03795610 - Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma Phase 2