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

NCT ID: NCT02009384

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-10-31

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.

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.

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ipilimumab

IV ipilimumab

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

administration of IV ipilimumab for up to 4 cycles

Interventions

Ipilimumab

administration of IV ipilimumab for up to 4 cycles

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Jason Chesney

Director, James Graham Brown Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Chesney, MD

Role: PRINCIPAL_INVESTIGATOR

Brown Cancer Center, University of Louisville

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

BCC-MEL-11-01

Identifier Type: -

Identifier Source: org_study_id