Clinical Trial: A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery
Brief 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.
Detailed Summary:
Patients with MPNST, who are not eligible for surgery of curative intent, will be considered for treatment with pembrolizumab. Patients will receive pembrolizumab treatment for up to 10 cycles. The patients must discontinue study treatment earlier (before 10 cycles of pembrolizumab) if they experience symptomatic deterioration attributed to disease progression, intolerable toxicity related to pembrolizumab, any medical condition that may jeopardize the patient's safety, use of other non-protocol anti-cancer therapy or pregnancy.
Patients who have received 10 cycles of pembrolizumab or discontinued study treatment of another reason than progression, will in the follow-up period be assessed for safety and treatment-related toxicity (for up to 90 days), progression and survival.
Patients who have achieved a clinical meaningful response after 10 cycles of pembrolizumab, defined as complete response (CR), partial response (PR), and stable disease (SD) assessed by the Investigator by using RECIST, v1.1, and have not experienced any clinically significant toxicity of study treatment, may be considered for reintroduction of pembrolizumab, if progression is detected after cycle 10.
Due to the low incidence of MPNST, the inclusion rate is expected to be low, thus a Simon's two-stage design is suggested (see Statistical Analysis Plans - Section 8.0).
Evaluation of efficacy and safety in stage one will be performed after the first 7 patient has been treated for 18 weeks: In case of no responders; the trial ends. If one or more responders, the trial will continue into stage two to a total number of 18 patients will be included.
Sponsor: Oslo University Hospital
Current Primary Outcome: Percentage of patients with at least stable disease after 18 weeks of treatment assessed by RECIST 1.1. [ Time Frame: 18 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Oslo University Hospital
Dates:
Date Received: February 4, 2016
Date Started: June 2016
Date Completion: December 2025
Last Updated: June 7, 2016
Last Verified: June 2016
