Pembrolizumab With or Without Talimogene Laherparepvec in Squamous Cell Carcinoma of the Head and Neck

Phase 1

• Conditions: Metastatic Squamous Cell Carcinoma of the Head and Neck; MedDRA version: 20.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003011-38-DE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-22
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• Male or female age = 18 years with histologically confirmed diagnosis of metastatic or recurrent SCCHN of the oral cavity, oropharynx, hypopharynx, or larynx. Disease must be unsuitable for curative surgical resection and must not be amenable to curative radiotherapy.

• Disease must have progressed after treatment with a platinumcontaining regimen

• Subject must be candidate for intralesional therapy administration defined as one or more of the following:
- At least 1 injectable cutaneous, subcutaneous, or nodal SCCHN tumor = 10 mm in longest diameter
- Multiple injectable cutaneous, subcutaneous, or nodal SCCHN tumors that in aggregate have a longest diameter of = 10 mm

• Subject must have radiographically measurable disease

• ECOG performance status of 0 or 1

• Adequate organ function determined within 14 days prior to enrollment

• PTT or aPTT = 1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants. Female subject of childbearing potential must have a negative pregnancy test within 72 hours prior to enrollment. If urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

• Phase 1b: Subject has a formalin fixed paraffin-embedded tumor sample (within 6 months prior to week 0, day 1 of the study, or newly obtained biopsy) from the primary or metastatic lesion that must be submitted within 4 weeks of enrollment for PD-L1, HPV-testing of oropharyngeal cancer (if not performed locally) and biomarker analyses.

Phase 3: Subject has a tumor sample and no systemic therapy given since the biopsy or newly obtained biopsy from the primary or metastatic lesion that is adequate for PD-L1 assessment prior to randomization

• Phase 3: Have results from local testing of HPV of tumor specimen for oropharyngeal cancer defined as p16 IHC testing using the CINtec® assay and a 70% cutoff point
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 392
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion Criteria

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis, primary nasopharyngeal carcinoma
• Subject at risk of airway compromise in the event of postinjection tumor swelling/inflammation based on investigator judgment
• Phase 3: Greater than three lines of prior therapy for current malignancy and/or metastatic disease
• History of other malignancy within the past 3 years, history of interstitial lung disease (ILD)
• Prior therapy with talimogene laherparepvec, pembrolizumab, other anti-PD-1, any other antibody or drug specifically targeting T-cell costimulation or immune check point pathway
• History or evidence of active autoimmune disease that has required systemic treatment in the past 2 years, evidence of clinically significant
immunosuppression
• Prior or active herpetic infection, require treatment with an antiherpetic drug, other than intermittent topical use
• Prior cancer therapy, targeted therapy, or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment.
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Subjects with tumor that directly contacts or encases a major blood vessel AND there is ulceration and/or fungation onto the skin surface.
• History of re-irradiation to a field which includes the carotid arteries.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified