A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients

NCT02009397 | Completed Phase 1 Results DMC

• 1 other identifier: BCC-MEL-11-02 (Ipi2)
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Change in Immune-related Overall Response Rate (irORR)

  assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab

Study Arms (1)

Ipilimumab and GM-CSF

EXPERIMENTAL

IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles

Drug: Ipilimumab; Drug: GM-CSF

Interventions

Ipilimumab DRUG

Ipilimumab and GM-CSF

GM-CSF DRUG

Ipilimumab and GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be entered in the study only if they meet all of the following criteria.
• Male or female patients ≥18 years of age;
• Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
• Life expectancy ≥3 months;
• At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
• Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
• Absolute neutrophil count (ANC) ≥1.0 x 109/L;
• Platelet count ≥50 x 109/L;
• Hemoglobin ≥8 g/dL;
• Serum creatinine ≤3 x upper limit of normal (ULN)
• Total serum bilirubin ≤2 x ULN;
• Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
• Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
• Pre-menopausal females and females \<2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;

You may not qualify if:

• Patients will not be entered in the study for any of the following:
• Treatment with Denileukin Diftitox within 42 days prior to the start of Ipilimumab;
• Prior treatment with Ipilimumab;
• Known hypersensitivity to Ipilimumab or any of its components
• Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤1, except for alopecia;
• Steroids within one week prior to initiation of Ipilimumab.
• Pre-existing autoimmune colitis.
• Patients with an allograft requiring immunosuppression;
• Known positive human immunodeficiency virus (HIV)
• Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
• Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

• Title: Dr. Jason Chesney
• Organization: University of Louisville, James Graham Brown Cancer Center

jason.chesney@louisville.edu

502-562-3429

Study Officials

• Jason Chesney, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, James Graham Brown Cancer Center

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: February 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 22, 2021
• Results First Posted: November 22, 2021

Record last verified: 2021-10

Locations

US (1)