Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox

NCT02009384 | Terminated Phase 2 Results DMC

• 1 other identifier: BCC-MEL-11-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Using Immune-related Response Criteria (irRC)

  no outcomes available, Study was Terminated due to low subject enrollment \[r/t requirement of prior treatment with denileukin diftitox\] Data was not analyzed

  baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

Study Arms (1)

Ipilimumab

EXPERIMENTAL

IV ipilimumab

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

administration of IV ipilimumab for up to 4 cycles

Ipilimumab

Eligibility Criteria

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

You may qualify if:

• 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;
• Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
• 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 ≥100 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:

• Prior treatment with Ipilimumab;
• Known hypersensitivity to Ipilimumab or any of its components;
• 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

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

Results Point of Contact

• Title: Jason Chesney
• Organization: University of Louisville

502-562-3429

Study Officials

• Jason Chesney, MD

  Brown Cancer Center, University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)