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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02608437
• Date of registration: 13/11/2015
• Prospective Registration: No
• Primary sponsor: Italian Network for Tumor Biotherapy Foundation
• Public title: A Study Investigating SGI-110 in Combination With Ipilimumab in Unresectable or Metastatic Melanoma Patients NIBIT-M4
• Scientific title: A Phase 1b, Open-label, Dose Escalation Study Investigating Different Doses of SGI-110 in Combination With Ipilimumab in Unresectable or Metastatic Melanoma Patients
• Date of first enrolment: October 2015
• Target sample size: 19
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02608437
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Italy

Contacts

• Name: Anna Maria Di Giacomo, PhD,MD
• Affiliation: Medical Oncology and Immunotherapy Unit, University Hospital of Siena

• Name: Anna Maria Di Giacomo, PhD, MD

• Name: Anna Maria Di Giacomo, PhD,MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Willing and able to give written informed consent

- Unresectable Stage III or Stage IV melanoma with measurable lesions by CT or MRI per
mWHO/irRC criteria, that can be amenable to biopsy

- Previously treated or untreated; prior therapy may include chemotherapy or targeted
therapy for metastatic disease (i.e., BRAF and/or MAP-ERK kinase (MEK) inhibitor).
Prior adjuvant interferon is permitted

- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- 4 weeks or greater since last treatment

- Must have recovered from any acute toxicity associated with prior therapy

- Life expectancy greater than 16 weeks

- Negative screening tests for HIV, Hepatitis B, and Hepatitis C

- Women of child-bearing potential must not be pregnant or breastfeeding, must have a
negative pregnancy test at Screening and all men must be practicing two medically
acceptable methods of birth control. Men should not father a child while receiving
treatment with SGI-110 + ipilimumab, and for 2 months following completion of
treatment. Men with female partners of childbearing potential should use effective
contraception during this time

Exclusion Criteria:

- Subjects with any contraindications for ipilimumab

- Subjects with active brain metastases or leptomeningeal metastases

- Subjects with metastatic uveal melanoma

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within
14 days of treatment

- Subjects with symptomatic effusions on account of pleural, pericardial metastases of
melanoma

- Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed
Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-CTLA-4 antibody

- Subjects who had major surgery or radiation therapy within 21 days of starting
treatment

- Subjects who are unable to return for follow-up visits as required by this study

Other Exclusion Criteria:

- Prisoners or subjects who are involuntarily incarcerated

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (e.g., infectious disease) illness.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Melanoma

Intervention(s)

Drug: Ipilimumab

Drug: SGI-110

Primary Outcome(s)

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

Secondary Outcome(s)

Immune-related Objective Response Rate (irORR) [Time Frame: weeks 24]

Immune-related progression free survival (irPFS) [Time Frame: 2 years]

Immune-related Time to Response (irTTR) [Time Frame: weeks 24]

Immune-related Disease Control Rate (irDCR) [Time Frame: weeks 24]

Immune-related Duration of Response (irDoR) [Time Frame: 2 years]

Secondary ID(s)

NIBIT-M4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Astex Pharmaceuticals