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Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

Head and Neck Neoplasms

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Pembrolizumab

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Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient.

Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions.

OBP-301

Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year

Doru Paul, MD

The purpose of this study is to test the effects, of the research study drug Telomelysin (OBP-301) in combination with pembrolizumab in subjects with inoperable, recurrent, or progressive squamous cell carcinoma of the head and neck. Telomelysin is an investigational treatment, while pembrolizumab and SBRT are approved standard treatments. The combination of these three treatments is also considered investigational.

This is a phase II open label single arm study of OBP-301 in combination with pembrolizumab and SBRT in advanced HNSCC which is either recurrent and inoperable, or progressing after prior radiation with curative-intent for advanced disease (adjuvant or definitive with or without chemotherapy or cetuximab).

The efficacy of pembrolizumab monotherapy is modest in second or third line of treatment of advanced head and neck cancer (\~response rate 16-22%). SBRT reirradiation in patients that received prior surgery and chemoradiation for advanced disease is associated with a response rate (RR) of approximately 60% and approximately 50% 1-year survival. Recently, the results of the Keynote-048 study were published. The projected 1-year survival in the immunotherapy arms with pembrolizumab alone or pembrolizumab and chemotherapy was approximately 57%. So, at present, the benchmark RR for patients with head and neck squamous cell carcinoma with inoperable, recurrent or progressive disease treated with SBRT is approximately 60% and the 1 year survival for patients with head and neck squamous cell carcinoma (HNSCC) with inoperable, recurrent or progressive disease using the most effective contemporary treatments including immunotherapy is approximately 50-57%. Trying to improve the results of the current standard of care, this study will examine the effects of oncolytic virus, OBP-301, administered in addition to pembrolizumab and SBRT in this patient population. The goal of using this triple therapeutic combination is to enhance the chances of cure of the patients.

A total of 36 patients will be enrolled into a two-stage parallel cohort design: In the first stage, 12 patients will be enrolled.

All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient.

If the targeted injected lesion(s) disappear, another lesion can be injected at the Investigator's discretion.

A minimum additional 3 doses of concurrent OBP-301 and pembrolizumab will be given if no toxicity, technical impediment to injection or progression is seen.

A maximum total of up to 9 doses of concurrent OBP-301 and pembrolizumab will be given.

Pembrolizumab alone will be continued after day 183 for a total treatment time up to 1 year.

Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With HNSCC With Inoperable, Recurrent or Progressive Disease

Phase 2 Study of OBP-301 (Telomelysin ™) in Combination With Pembrolizumab and Stereotactic Body Irradiation in Patients With Head and Neck Squamous Cell Carcinoma With Inoperable, Recurrent or Progressive Disease

Examination of patients with a partial response or complete response.

We will measure the rate of grade 3 or 4 adverse events attributed to the combination of multiple intratumoral injections of OBP-301 with SBRT and pembrolizumab.

Examination of subjects with stable disease, a partial response, or complete response.

Defined as the time from registration to death from any cause.

Defined as the time from registration to cancer progression or death due to any cause

defined as the percentage of patients who have achieved complete response, partial response and stable disease.

Examination of subjects with stable disease, a partial response, or complete response.Immune-related disease progression (irPD) will be confirmed if the increase in tumor burden is ≥ 25% relative to nadir (minimum recorded tumor burden).

Examination of patients with a partial response or complete response based on RECIST 1.1 and iRECIST

Oncolys BioPharma Inc

Weill Medical College of Cornell University

All patients will receive intratumoral injection(s) with OBP-301. If tolerated and no progression is observed, up to twelve injections may be given in each patient.

OBP-301: Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions.

Pembrolizumab: Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year

Telomelysin (OBP-301)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Meyer Cancer Center GI Program Manager

Overall Response Rate, as Assessed by Radiographic Imaging

Occurrence of Significant Toxicity, as Measured by Number of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to the Combination of Multiple Intratumoral Injections of OBP-301 With SBRT and Pembrolizumab.

Spots Global Cancer Trial Database for head and neck squamous cell carcinoma with inoperable recurrent or progressive disease