Study S002158

Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT01029873
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1; PHASE2
Masking: NONE
Status: TERMINATED
Enrollment: 22
Start: 2010-02
Primary completion: 2011-11
Lead sponsor: Altor BioScience
Conditions: Metastatic Melanoma
Interventions: DRUG:Cisplatin; BIOLOGICAL:ALT-801
Results posted: TRUE
Secondary identifiers: NIH:R44CA097550

Registered primary outcomes

To Evaluate the Safety of ALT-801-cisplatin Regimen by the Number of Participants With AEs. [Up to 12 months]
To Assess the Objective Response (OR) Which Includes CR and PR [3 months]
To Assess the Clinical Benefit (CB) of the ALT-801-Cisplatin Regimen Which Includes CR, PR and SD [3 months]
To Determine the MTD of the ALT-801-Cisplatin Regimen Determined by Number of Participants With DLTs [7 weeks]

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