NL-OMON48631
Completed
Not Applicable
A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors - MS201781-0031
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Merck KGaA
- Enrollment
- 7
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •UrothelialSigned written informed consent
- •2\. Male or female subjects age \* 18 years
- •3\. Subjects must have one of the following tumor specific indications:
- •\-a. Locally advanced or metastatic urothelial carcinoma (UC) post\-that has
- •progressed during or after at least one platinum:\-based chemotherapy and not
- •previously been treated with anti\-PD\-1/PD\-L1 agents (PD\-x naïve):
- •Histologically or cytologically confirmeddocumented locally advanced or
- •metastatic transitional cell carcinoma of the urothelium (including renal
- •pelvis, ureters, urinary bladder, and urethra). Subjects must have progressed
- •during or after treatment with at least 1 platinum \-containing regimen (eg,
Exclusion Criteria
- •1\. Concurrent treatment with a non\-permitted drug/intervention (listed below)
- •a. Anticancer treatment (eg, cytoreductive therapy, radiotherapy, immune
- •therapy, cytokine therapy, monoclonal antibody, targeted small molecule
- •therapy) or any investigational drug within 4 weeks or 5 half\-lives, whichever
- •is shorter, prior to start of study treatment, or not recovered from adverse
- •events (AE) related to such therapies, with the following exceptions:
- •i. Palliative radiotherapy delivered in a normal organ\-sparing technique is
- •permitted (concurrently or within pretreatment period).
- •ii. Erythropoietin, darbepoetin\-\*, and granulocyte colony\-stimulating factor
- •are permitted.
Outcomes
Primary Outcomes
Not specified
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