Clinical trial · Interventional
Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine
A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma
NCT00796991CI-TRIAL-00013334completedPhase 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 learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- interventionNames
- Drug: Ipilimumab
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- interventionNames
- Drug: Ipilimumab
- Drug: Dacarbazine
- type
- ACTIVE_COMPARATOR
- label
- Arm C
- interventionNames
- Drug: Ipilimumab
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of advanced malignant melanoma * Eastern Cooperative Oncology Group (ECOG) performances status 0-1 * Measurable/evaluable disease as per modified World Health Organization (mWHO) criteria Exclusion Criteria: * Evidence of active brain metastases * Prior treatment with anti-cytotoxic lymphocyte antigen 4 (CTLA-4) or anti-CD137 (type of tumor necrosis factor) antibody * Total Bilirubin greater than (\>) 1.5 \* upper limit of normal (ULN) and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 \* upper limit of normal (ULN) * Prior Autoimmune disease * Use of immunosuppressing therapies
References
Publications (0)
Data not yet available
No reference posted for this study.