Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial (PEMBROSARC)

Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial (PEMBROSARC)

Sarcoma

Active, not recruiting

2

Start Date 03/01/2015

Age of Trial (yrs) 9.2

Gleevec-resistant

Immunotherapeutic

Stimulate the immune system, Modulate the anti-inflammatory immune response

Specifically GIST plus other cancers

IB 2014-04 PEMBROSARC

Institut Bergonié

Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr Simone Mathoulin-Pelissier, MD,PhD s.mathoulin-pelissier@bordeaux.unicancer.fr

Oral Intravenous

Primary Outcome Measures:

Assessment of the efficacy of MK3476 associated with Metronomic Cyclophosphamide per RECIST v1.1 criteria [ Time Frame: 6 months ]

This primary objective of this study is to assess the efficacy of MK3475 and Metronomic

Cyclophosphamide (CP) independently for 5 strata as per RECIST v1.1 criteria :

In terms of 6-month objective response and 6-months non progression for:
Advanced leiomyosarcoma
Advanced undifferentiated sarcoma
Advanced other sarcoma
Advanced osteosarcoma

In terms of·6-month non progression for:

Advanced GIST

Inclusion Criteria:

Histology : Leiomyosarcoma, or UPS, or other sarcoma, or GIST or osteosarcoma, histologically confirmed by central review
Advanced non resectable / metastatic disease
Documented progression according to RECIST criteria. Progression on the last line of treatment should be confirmed by central review with two radiological assessments identical obtained at less than 6 months interval within the 12 months before inclusion
For stratum 5, documented disease progression according to RECIST criteria after the first line imatinib and second line sunitinib
Have provided tissue from an archival tissue sample obtained on metastasis or on locally advanced disease, or newly obtained core or excisional biopsy of a tumor lesion