Clinical trial · Interventional
Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma
A Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced Melanoma
NCT00920907CI-TRIAL-00014890completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ipilimumab (Process B)
- description
- Reference
- interventionNames
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Ipilimumab (Process C)
- description
- Test
- interventionNames
- Biological: Ipilimumab
Primary outcomes (2)
- measure
- Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population
- timeFrame
- Day 1 to Day 84
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKitano S, Postow MA, Ziegler CG, Kuk D, Panageas KS, Cortez C, Rasalan T, Adamow M, Yuan J, Wong P, Altan-Bonnet G, Wolchok JD, Lesokhin AM. Computational algorithm-driven evaluation of monocytic myeloid-derived suppressor cell frequency for prediction of clinical outcomes. Cancer Immunol Res. 2014 Aug;2(8):812-21. doi: 10.1158/2326-6066.CIR-14-0013. Epub 2014 May 20. PMID 24844912
- DERIVEDIwama S, De Remigis A, Callahan MK, Slovin SF, Wolchok JD, Caturegli P. Pituitary expression of CTLA-4 mediates hypophysitis secondary to administration of CTLA-4 blocking antibody. Sci Transl Med. 2014 Apr 2;6(230):230ra45. doi: 10.1126/scitranslmed.3008002. PMID 24695685