TRIAL DETAIL

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

Drug:
Trial Name:
Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial (PEMBROSARC)
NCT#:
Conditions:
Sarcoma
Status:
Recruiting
Phase:
2
Start Date 03/01/2015
Age of Trial (yrs) 4.6
Treatment Phase:
Gleevec-resistant
Drug Category:
Immunotherapeutic
Strategy:
Stimulate the immune system, Modulate the anti-inflammatory immune response
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
IB 2014-04 PEMBROSARC
Sponsor:
Institut Bergonié
Patient Contact:
Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr Simone Mathoulin-Pelissier, MD,PhD s.mathoulin-pelissier@bordeaux.unicancer.fr
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral Intravenous
Trial Notes:
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

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
229 Cours Argonne
Bordeaux
Gironde
33076
France
Lille
Nord
59020
France
28 rue Laennec
Lyon
Rhone
69008
France
Marseille
Bouches du Rhone
13273
France
Nantes
Loire Atlantique
44805
France
Toulouse
31052
France
Villejuif
Val de Narne
94805
France
Paris
75005
France