EUCTR2020-001908-42-HU
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced/metastatic solid tumors
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 185
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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
Outcomes
Primary Outcomes
Not specified
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