A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination with IV Pembrolizumab vs IV Pembrolizumab Monotherapy - Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IV

Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc0 sites200 target enrollmentFebruary 6, 2020

ConditionsPatients with metastatic or unresectable, recurrent HNSCC Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA (pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with metastatic or unresectable, recurrent HNSCC
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc
Enrollment: 200
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 6, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc

Eligibility Criteria

Inclusion Criteria

•1\. Has histologically or cytologically confirmed diagnosis of metastatic or unresectable,recurrent HNSCC that is considered incurable by local therapies.
•Has not had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent, if given as part of multimodal treatment for locally advanced disease, is allowed.
•The eligible primary tumor must be located in oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).
•2\. Has tumor PD\-L1 expression of CPS \=1\.
•3\. Has at least 1 measurable lesion which is amenable to injection. IT injection for cutaneous lesions may be performed via visual inspection. IT injection for subcutaneous lesions may be performed via ultrasound guidance or via palpation. This injectable lesion must be measurable and meet one of the following criteria:
•A cutaneous or subcutaneous lesion \=1 cm in longest diameter for solid tumors, or \=1\.5 cm in short axis for a nodal lesion in solid tumor subjects. The longest diameter for an injectable lesion must be \=10 cm for both solid tumors and nodal lesions in solid tumor subjects.
•Multiple coalescing, superficial lesions which in aggregate have a longest diameter of \=1 cm and \=10 cm.
•4\. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\.
•5\. Demonstrates adequate organ function
•6\. Has results from testing of HPV status for oropharyngeal cancer defined as p16 IHC testing using CINtec® p16 Histology assay and a 70% cutoff point (please see the Procedures Manual for details). If HPV status was previously tested, then no additional testing is required.

Exclusion Criteria

•1\.Has disease that is suitable for local therapy administered with curative intent
•2\. Has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
•3\. Has had chemotherapy or biological cancer therapy in the recurrent or metastatic setting for the treatment of HNSCC
•4\. Has had radiation therapy within 2 weeks prior to randomization or subject has not fully recovered from adverse events due to a previously administered treatment
•5\. Is expected to require any other form of antineoplastic therapy while on study
•6\. Has a history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for at least 2 years
•7\. Has clinically active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic, have no evidence of new or enlarging brain metastases, are evaluated within 4 weeks prior to first study intervention administration, and are off immunosuppressive doses of systemic steroids at least 2 weeks prior to enrolment
•8\. Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment and is allowed. Use of nonsystemic steroids is permitted
•9\. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Corticosteroid use as premedication for allergic reactions is allowed
•10\. Has had an allogenic tissue/solid organ transplant