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

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT02009397
• Collaborator: James Graham Brown Cancer Center (Other)
• Enrollment: 27
• Location: 1
• Arm: 1
• Duration (Months): 57
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Drug: Ipilimumab; Drug: GM-CSF	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ipilimumab and GM-CSF IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles	Drug: Ipilimumab; Drug: GM-CSF

Outcome Measures

Primary Outcome Measures

1. Change in Immune-related Overall Response Rate (irORR) [assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients may be entered in the study only if they meet all of the following 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. At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);

6. 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.

1. 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;

2. 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;

3. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria:

• Patients will not be entered in the study for any of the following:

1. Treatment with Denileukin Diftitox within 42 days prior to the start of Ipilimumab;

2. Prior treatment with Ipilimumab;

3. Known hypersensitivity to Ipilimumab or any of its components

4. 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;

5. Steroids within one week prior to initiation of Ipilimumab.

6. Pre-existing autoimmune colitis.

7. Patients with an allograft requiring immunosuppression;

8. Known positive human immunodeficiency virus (HIV)

9. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;

10. Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville
• James Graham Brown Cancer Center

Investigators

• Principal Investigator: Jason Chesney, MD, PhD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jason Chesney, Director, James Graham Brown Cancer Center, University of Louisville
• ClinicalTrials.gov Identifier: NCT02009397
• Other Study ID Numbers: BCC-MEL-11-02 (Ipi2)
• First Posted: Dec 12, 2013
• Last Update Posted: Nov 22, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Melanoma; Ipilimumab

Study Results

Participant Flow

Arm/Group Title	Ipilimumab and GM-CSF
Arm/Group Description	IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Period Title: Overall Study
STARTED	26
COMPLETED	6
NOT COMPLETED	20

Baseline Characteristics

Arm/Group Title	Ipilimumab and GM-CSF
Arm/Group Description	IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Overall Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 69.2%
>=65 years	8 30.8%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	58
Sex: Female, Male (Count of Participants)
Female	8 30.8%
Male	18 69.2%
Region of Enrollment (Count of Participants)
United States	26 100%

Outcome Measures

1. Primary Outcome

Title	Change in Immune-related Overall Response Rate (irORR)
Time Frame	assessed at baseline and at 4 weeks (±1 week) following the last administration of Ipilimumab

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ipilimumab and GM-CSF
Arm/Group Description	IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
Measure Participants	20
Number [participants]	20 76.9%

Adverse Events

Arm/Group Title	Ipilimumab and GM-CSF
Arm/Group Description	IV ipilimumab followed by subcutaneous GM-CSF, for up to 4 cycles Ipilimumab GM-CSF
All Cause Mortality
	Ipilimumab and GM-CSF
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ipilimumab and GM-CSF
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	Ipilimumab and GM-CSF
	Affected / at Risk (%)	# Events
Total	0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.