VERSATILE-002 study on the inclusion of previously treated HPV + HNSCC according to protocol change


A protocol change of the VERSATILE-002 study (NCT04260126) with PDS0101 plus pembrolizumab (Keytruda) for certain patients with head and neck cancer enables the inclusion of patients in whom previous checkpoint inhibitor therapy has failed in an additional study arm, so the PDS Biotechnology Corporation.1

The liposomal nanoparticle-based PDS0101 vaccine, which encapsulates 6 peptides of the human papillomavirus 16 (HPV-16), is used to treat patients with HPV-related cancers.2 First, the non-randomized, multicenter, open phase 2 study was opened to examine the effectiveness of the combination in patients with treatment-naive HPV-related head and neck malignancies.

“There is a tremendous unmet medical need for patients with advanced head and neck cancer who have failed multiple therapies, including chemotherapy, radiation, and checkpoint inhibitor therapy. We believe the combination of PDS0101 and Keytruda has the potential to significantly improve the clinical outcomes of these limited treatment options, ”said Lauren Wood, MD, chief medical officer of PDS Biotech, in a press release.

The additional arm will evaluate the objective response rate (ORR) resulting from treatment with PDS0101 plus pembrolizumab in approximately 40 patients with refractory head and neck cancer who have failed multiple therapies, including immunotherapy. The ORR is measured by radiological response of the tumor according to RECIST 1.1. The first 21 patients in the treatment arm will be screened for safety and response rate before they are included in the full admissions.

To be eligible for inclusion, patients must be at least 18 years old; have histologically or cytologically confirmed squamous cell carcinoma of the head and neck that is recurrent, metastatic, or persistent with HPV16 infection or PD-L1 expression. In addition, adequate organ function and an ECOG performance status of 0 or 1.

Patients who received prior radiation therapy within 2 weeks or who received live vaccine or prior systemic cancer within 30 days are excluded from the study. Other known malignancies within 3 years and hematopoietic stem cell transplants within 5 years are not allowed.

The results of a phase 1/2 study with PDS0101 in combination with 2 other investigational immunotherapies, M9241 and bintrafusp a, in 14 patients will be presented at the upcoming annual meeting of the American Society of Clinical Oncology in 2021.3 The study population included those with cervical, vaginal / vulvar, anal, and oropharyngeal cancer with checkpoint inhibitor refractory and naive diseases.

Promising responses have been seen in patients with and without prior experience with an immunotherapeutic agent. In those whose disease failed on chemotherapy, radiation, and checkpoint inhibitors (n = 8), the ORR was 63%. In addition, the combination showed a manageable safety profile in the patient population studied.

VERSATILE-002 currently operates in approximately 20 locations across the United States, with Jared Weiss, MD, of the University of North Carolina serving as the lead investigator at the Chapel Hill School of Medicine and the Lineberger Comprehensive Cancer Center.


1. PDS Biotechnology expands the VERSATILE-002 study of PDS0101 and KEYTRUDA in advanced head and neck cancer to include patients who have previously failed treatment with checkpoint inhibitors. Press release. PDS Biotechnology Corporation. June 3, 2021. Accessed June 3, 2021.

2. HPV-16 E6 / E7 liposomal multipeptide vaccine PDS0101. National Cancer Institute. Accessed June 3, 2021.

3. Strauss J., Floudas CS, Sater HA, et al. Phase II evaluation of the triple combination of PDS0101, M9241 and bintrafusp alfa in patients with HPV-16 positive malignancies. J Clin Oncol. 2021; 39 (supplement 15): 2501. doi: 10.1200 / JCO.2021.39.15_suppl.2501

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