A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) in Participants with Advanced/Metastatic Solid Tumors - Phase 1b/2 Study of ITu V937 in Combination with Pembrolizumab

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 sites185 target enrollmentFebruary 3, 2021

ConditionsAdvanced/metastatic solid tumors MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsKEYTRUDA (pembrolizumab, MK-3475 )

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced/metastatic solid tumors
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Enrollment: 185
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 3, 2021

End Date

TBD

Last Updated

2 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 locally\-advanced disease that is not amenable to surgery or radiation, or Stage IV advanced/metastatic solid tumor malignancies
•2\. Has histologically\- or cytologically\-confirmed diagnosis of an advanced/metastatic solid tumor
•3\. Has measurable disease by RECIST 1\.1 criteria as assessed by investigator. Target lesions in a previously irradiated area will be considered measurable if progression has been demonstrated in such lesions
•4\. Has submitted a baseline tumor sample for analysis (either de novo biopsy or an archival tumor block)
•5\. Has a performance status of 0 or 1 on the ECOG Performance Scale obtained within 72 hours prior to the first dose of study intervention
•6\. If participants have known HIV\-positive disease, participants must have well\-controlled HIV on ART defined as:
•a. CD4\+ T\-cell count \>350 cells/mm3 at the time of screening
•b. Must have achieved and maintained virologic suppression, defined as HIV RNA levels below 50, or LLOQ (below limits of detection), using a locally available assay at the time of screening
•c. Must be on a stable regimen without any changes in drugs or dose modifications for a minimum of 4 weeks prior to study entry (Day 1\)
•7\. Demonstrate adequate organ function

Exclusion Criteria

•1\. Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to first dose of study intervention, or has not recovered to CTCAE Grade 1 or better
•2\. If major or minor surgery was performed at/near the area being considered for injection, participant must be recovered from toxicity and/or complications of intervention
•3\. Has had injection, or radiation therapy of \>30 Gy, participant must be recovered from toxicity and/or complications of intervention
•4\. Has a history of second malignancy, unless potentially curative treatment has been completed with no further evidence of malignancy
•5\. Has known active CNS metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate if lesions are radiologically stable
•6\. Has an active infection requiring therapy
•7\. Has a history of interstitial lung disease
•8\. Has a history of noninfectious pneumonitis requiring active steroid therapy or ongoing pneumonitis
•9\. Has an active autoimmune disease that required systemic treatment in the past 2 years (ie, necessitating use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement therapy (steroid use \=10 mg prednisone, or its equivalent, daily) is not considered a form of systemic treatment and is allowed. The use of non\-systemic steroids is permitted
•10\. Participants with known Hepatitis B or C infections or known to be positive for HBsAg/HBV DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay