A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery
NCT02691026 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2021-06-23
Summary
This is phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475) in subjects with metastatic or locally advanced/unresectable or metastatic malignant peripheral nerve sheath tumour (MPNST).
The patients will be treated with pembrolizumab for up to 10 cycles.
Primary objective is to evaluate the percentage of patients with curatively unresectable MPNST who have achieved clinical response; complete response (CR), partial response (PR), or stable disease (SD) at 18 weeks as assessed by the Investigator, by using RECIST, v1.1.
Conditions
- Malignant Peripheral Nerve Sheath Tumour (MPNST)
Interventions
- DRUG
Sponsors & Collaborators
- collaborator INDUSTRY
-
Oslo University Hospital
lead OTHER
Principal Investigators
-
Tormod K Guren, MD, PhD · Oslo University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- Norway
Study Locations
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