A Phase II of Nivolumab Plus Ipilimumab in Non-resectable Sarcoma and Endometrial Carcinoma

Sponsor
Assaf-Harofeh Medical Center
Study ID
NCT02982486
Phase
PHASE2
Status
Unknown

Conditions

  • Bone Sarcoma
  • Chondrosarcoma
  • Desmoplastic Small Round Cell Tumor
  • Ewing's Tumor Metastatic
  • Ewing's Tumor Recurrent
  • Gastrointestinal Stromal Sarcoma
  • Osteosarcoma
  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 1 mg/kg every 6 weeks
  • Nivolumab — DRUG
    Ninolumab 240 mg IV every 2 weeks

Study Details

The purpose of this study is to determine whether nivolumab plus ipilimumab are effective and safe in the treatment of sarcoma and endometrial carcinoma patients with somatic deficient MMR as a selection tool.

Key Dates

Start date
Dec 31, 2017
Status verified
Oct 2017
Primary completion
Jun 30, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and ipilimumab
    Nivolumab 240 mg IV every 2 weeks plus Ipilimumab 1 mg/m2 IV every 6 weeks

Primary Outcome Measure

Response to therapy as evaluated by RECIST 1.1 [ Time Frame: 36 months ]

Central Contacts

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