Last updated on November 2019

A Study of Intratumoral/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies (V938-001)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastasis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • For Dose-escalation Phase (Doses A-C): Have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, or been ineligible for treatments known to confer clinical benefit.
  • For Dose Confirmation Arm A: Have a histologically or cytologically confirmed Stage III (unresectable) or Stage IV cutaneous melanoma and have received, been intolerant to, or been ineligible for treatments known to confer clinical benefit.
  • For Dose Confirmation Arm B: Have a histologically or cytologically confirmed advanced head and neck squamous cell carcinoma (HNSCC) and have received, been intolerant to, or been ineligible for treatment known to confer clinical benefit.
  • For Dose Confirmation Arms A and B: Have at least 1 lesion that is amenable to both intratumoral injection and biopsy.
  • For all arms: Have at least 1 cutaneous or subcutaneous lesion amenable to intratumoral injection, and have at least 1 distant and/or discrete noninjected lesion that is measurable per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
  • For all arms, the injectable lesion must be measurable and meet protocol-specified size criteria.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Demonstrate adequate organ function.
  • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 120 days: Refrain from donating sperm; PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR must agree to use contraception unless confirmed to be azoospermic.
  • Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential (WOCBP)
  • Is a WOCBP and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention.
  • HIV-infected participants must have well controlled HIV on antiretroviral therapy (ART), per study criteria.

Exclusion Criteria:

  • Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study intervention or has not recovered from any adverse events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study.
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer, or other in-situ cancers.
  • Has clinically active central nervous system metastases and/or carcinomatous meningitis.
  • Has had a severe hypersensitivity reaction to treatment with the monoclonal antibody/components of the study intervention or has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (Grade 3).
  • Has an active infection requiring therapy.
  • Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy.
  • Is on chronic systemic steroid therapy in excess of replacement doses (prednisone 10 mg/day is acceptable), or on any other form of immunosuppressive medication.
  • Participants with known Hepatitis B or C infections or known to be positive for hepatitis B antigen/hepatitis B virus DNA or hepatitis C antibody or RNA.
  • 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 requirements of the study.
  • Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention.
  • Has not fully recovered from any effects of major surgery without significant detectable infection.
  • Has received a live-virus vaccine within 30 days of planned treatment start.
  • Is currently participating and receiving study intervention in a study of an investigational agent or has participated and received study intervention in a study of an investigational agent or has used an investigational device within 28 days of administration of V938.
  • Has a history of re-irradiation for HNSCC at the projected injection site.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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