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

A Phase II Open-Label Study of Ipilimumab Administered to Stage IIIC and Stage IV Melanoma Patients After Regulatory T Cell Depletion With Denileukin Diftitox

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Drug: Ipilimumab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • James Graham Brown Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients ≥18 years of age;
2. Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
4. Life expectancy ≥3 months;
5. Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
6. At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);

7. 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.
8. 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;
9. 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;
10. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria:

1. Prior treatment with Ipilimumab;
2. Known hypersensitivity to Ipilimumab or any of its components;
3. Steroids within one week prior to initiation of Ipilimumab.
4. Pre-existing autoimmune colitis.
5. Patients with an allograft requiring immunosuppression;
6. Known positive human immunodeficiency virus (HIV)
7. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
8. Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ipilimumab; IV ipilimumab	Drug: Ipilimumab; administration of IV ipilimumab for up to 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: James Graham Brown Cancer Center
• Investigators: Principal Investigator: Jason Chesney, MD, Brown Cancer Center, University of Louisville

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: BCC-MEL-11-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No