A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants with Advanced/Metastatic Melanoma

Merck Sharp & Dohme LLC0 sites135 target enrollmentJanuary 21, 2020

DrugsKEYTRUDA (pembrolizumab, MK-3475)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 135
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 21, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Eligibility Criteria

Inclusion Criteria

•1\. Has histologically or cytologically confirmed diagnosis of advanced/metastatic melanoma
•2\. Has Stage III (unresectable) or Stage IV melanoma
•3\. Participants must be naive to anti\-PD\-(L)1 treatment, TVEC and other oncolytic viruses
•4\. Has 2 lesions as defined below:
•Lesion 1: Has at least 1 cutaneous or subcutaneous lesion amenable to IT injection and biopsy. The injectable lesion must be measurable and meet 1 of the following criteria (per RECIST 1\.1 for solid tumors):
•\- 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 participants with solid tumor. The longest diameter for an injectable lesion must be \= 10 cm for both solid tumors and nodal lesions in participants with solid tumor
•\- Multiple coalescing, superficial lesions that in aggregate have a longest diameter of \= 1 cm and \= 10 cm
•Lesion 2: Have at least 1 measurable, distant and/or discrete noninjected lesion that is amenable to biopsy via visual inspection or amenable to biopsy via image guidance, such as ultrasound or computed tomography (CT)/magnetic resonance imaging (MRI). The lesion must be measurable and meet 1 of the above mentioned criteria per RECIST 1\.1
•5\. Has a a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
•6\. Demonstrates adequate organ function

Exclusion Criteria

•1\.Has had chemotherapy, definitive radiation, or biological cancer therapy or an investigational agent or investigational device within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study intervention or has not recovered to Common Terminology Criteria for Adverse Events Grade 1 or better (except alopecia) from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier. If participant received major surgery or radiation therapy of\>30 Gy, they must have recovered from the toxicity and/or complications from the intervention. Participants receiving ongoing replacement hormone therapy for endocrine immune\-related AEs will not be excluded from participation in this study
•2\.Has ocular melanoma
•3\.Has radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis
•4\.Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
•5\.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
•6\.HIV\-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
•7\.Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
•8\.Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years
•9\. Has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that required general anesthesia must be completed at least 2 weeks before first study intervention administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before first study intervention administration and participants should be recovered
•10\.Clinically significant cardiovascular disease:cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication