Phase 1 Completed N=75 Randomized Treatment

Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma

Source: ClinicalTrials.gov NCT00920907 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

Mar 2014

Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population — 252.68; 251.26 μg/mL

Summary

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population	252.68; 251.26	—
PRIMARY Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Day 21, AUC(0-21d), of Ipilimumab Manufactured by Process C Relative to the AUC(0-21d) of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population	40374.47; 40085.9	—
SECONDARY Time of Maximum Observed Serum Concentration (Tmax) of Ipilimumab Manufactured by Process C Relative to the Tmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population	2.00; 2.50	—
SECONDARY Terminal Elimination Half Life (T-HALF) of Ipilimumab Manufactured by Process C Relative to the T-HALF of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population	15.45; 15.23	—
SECONDARY Clearance (CLT) of Ipilimumab Manufactured by Process C Relative to the CLT of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population	12.590; 12.934	—
SECONDARY Volume of Distribution at Steady State (Vss) of Ipilimumab Manufactured by Process C Relative to the Vss of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population	6.06; 5.96	—
SECONDARY Best Overall Tumor Response Per Investigator Based on Modified World Health Organization (mWHO) Criteria - All Randomized Participants	0; 1; 4; 10; 11; 7	—
SECONDARY Best Overall Tumor Response Per Investigator Based on Immune-related (ir) Response Criteria (RC) - All Randomized Participants	0; 1; 2; 9; 11; 8	—
SECONDARY Median Overall Survival Following First Ipilimumab Dose - All Treated Participants	20.58; 24.79	—
SECONDARY Model Estimates of Mean Absolute Lymphocyte Count at Each Nominal Ipilimumab Induction Dose and at End of the Induction Dosing Period	1.26; 1.18; 1.67; 1.74; 1.79; 1.86	0.85
SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation	37; 38; 33; 36; 22; 24	—
SECONDARY Number of Participants Who Developed Antibodies and Neutralizing Antibodies	0; 2; 0; 0	—
SECONDARY Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants up to Data Cutoff	-1.6; -1.4; -7.0; -5.6; 7.5; 2.3	—
SECONDARY Mean Change From Baseline in Sitting Pulse Rate - All Treated Participants up to Data Cutoff	-4.3; -3.3; -7.7; -7.1; 25.5; 12.3	—
SECONDARY Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Hematology Laboratory Safety Tests - All Treated Participants	2; 3; 3; 3; 0; 2	—
SECONDARY Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Chemistry Laboratory Safety Tests (Non-electrolyte) - All Treated Participants	2; 1; 2; 1; 2; 1	—
SECONDARY Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Electrolyte Laboratory Safety Tests - All Treated Participants	4; 6; 1; 2; 0; 1	—

Eligibility Criteria

Inclusion Criteria

Histologic diagnosis of malignant melanoma
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Measurable/evaluable disease per modified World Health Organization (mWHO) criteria

Exclusion Criteria

Active Brain Metastasis
Primary ocular or mucosal melanoma
Prior Autoimmune disease
Inadequate hematologic, hepatic or renal function
Use of immunosuppressants
Prior treatment with a CD137 agonist or cytotoxic T lymphocyte antigen 4 (CTLA-4) inhibitor

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Data sourced from ClinicalTrials.gov (NCT00920907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.