Efficacy Safety and Tolerability of V937 Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

  • STATUS
    Recruiting
  • End date
    Jul 29, 2024
  • participants needed
    135
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 21 July 2021

Summary

This is a Phase 2 study to assess the efficacy, safety, and tolerability of V937 administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that V937 administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone.

Details
Condition Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced/Metastatic Melanoma, Advanced Metastatic Melanoma
Treatment Pembrolizumab, V937 IV, V937 IT, V937 ITu
Clinical Study IdentifierNCT04152863
SponsorMerck Sharp & Dohme Corp.
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Has histologically or cytologically confirmed diagnosis of advanced/metastatic melanoma
Has Stage III or Stage IV melanoma
Must be naive to anti-PD-L1 treatment, talimogene laherparepvec (TVEC) and other oncolytic viruses
Has 2 lesions as defined below
At least 1 cutaneous or subcutaneous lesion that is amenable to IT injection and biopsy and measurable per RECIST 1.1
At least 1 distant and/or discrete noninjected lesion that is amenable to biopsy and measurable per RECIST 1.1
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Demonstrates adequate organ function
Male participants refrain from donating sperm during the intervention period and for at least 120 days after the last dose of study intervention PLUS are either abstinent from heterosexual intercourse OR agree to use approved contraception during that period
Female participants are not pregnant or breastfeeding and are not a woman of childbearing potential (WOCBP) OR are a WOCBP that agrees to use contraception during the treatment and for at least 120 days after the last dose of study intervention
Has measurable disease per RECIST 1.1
Is able to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART), defined as
Must have Cluster of Differentiation 4 (CD4)+ T-cell count >350 cells/mm^3 at time of screening
Must have achieved and maintained virologic suppression
Must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry
The combination ART regimen must not contain any antiretroviral medication other than abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir

Exclusion Criteria

Has had chemotherapy, definitive radiation, or biological cancer therapy or an investigational agent or investigational device within 4 weeks prior to the first dose of study intervention or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
Has ocular melanoma
Has radiographic evidence of major blood vessel infiltration
Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the study requirements
Has undergone allogeneic hematopoietic stem cell transplantation within the last 5 years
Has not fully recovered from major surgery without significant detectable infection
Active cardiovascular disease (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure or serious cardiac arrhythmia requiring medication
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other agents such as cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), OX-40, Cluster of Differentiation 137 (CD137)
Has received a live vaccine within 30 days prior to the first dose of study drug
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has hypersensitivity to pembrolizumab and/or any of its excipients
Has hypersensitivity to V937 or any of its excipients
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has had an allogenic tissue/solid organ transplant
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