EUCTR2019-003060-42-NO
Active, not recruiting
Phase 1
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 enrollmentDecember 12, 2019
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
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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 measurable disease per RECIST 1\.1, as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •4\. 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 participants. The longest diameter for an injectable lesion must be \=10 cm for both solid tumors and nodal lesions in solid tumor participants.
- •\-Multiple coalescing, superficial lesions which in aggregate have a longest diameter of \=1 cm and \=10 cm.
- •5\. Has an ECOG Performance Status of 0 or 1\.
- •6\. Demonstrates adequate organ function
Exclusion Criteria
- •1\.Has disease that is suitable for local therapy administered with curative intent
- •2\. Has PD 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
Outcomes
Primary Outcomes
Not specified
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