A Study Investigating SGI-110 in Combination With Ipilimumab in Unresectable or Metastatic Melanoma Patients

Sponsor
Italian Network for Tumor Biotherapy Foundation
Study ID
NCT02608437
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • SGI-110 — DRUG
    SGI-110: start at 30 mg/m2 s.c. on W0, 3, 6, 9 Day 1 - 5 q21 days. Dose level -1: 15 mg/m2; dose level +1: 45 mg/m2
  • Ipilimumab — DRUG
    ipilimumab: 3 mg/Kg i.v. over 90 minutes on W1, 4, 7 and 10 for a total of 4 cycles.

Study Details

Thi pahse I, dose-escalation trial will determine the MTD, safety and the additional benefit achieved from adding SGI-110 to ipilimumab therapy in metastatic melanoma patients. Preclinical evidence generated with SGI-110 in vivo demonstrated that besides having a direct activity on tumor growth as a single agent, SGI-110 was able to "sensitize" neoplastic cells to the anti-tumor activity of CTLA-4 blockade, providing a sound scientific rationale to develop new immunotherapeutic approaches combining SGI-110 with therapeutic mAb to immune check-points.

Key Dates

Start date
Oct 31, 2015
Status verified
Nov 2015
Primary completion
Oct 31, 2016
Completion
Oct 31, 2018

Study Design

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

Arms

  • Experimental: SGI-110 and Ipilimumab
    SGI-110 in combination with Ipilimumab

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of SGI-110 in combination with ipilimumab [ Time Frame: the first 3 weeks of treatment ]

Central Contacts

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