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A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Melanoma

Treatments

Drug: ipilimumab (MDX-010, BMS-734016)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00289627
CA184-008

Details and patient eligibility

About

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Patients with previously treated Stage III (unresectable)or Stage IV melanoma

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

155 participants in 1 patient group

ipilimumab (MDX-010, BMS-734016)
Experimental group
Treatment:
Drug: ipilimumab (MDX-010, BMS-734016)

Trial contacts and locations

54

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Data sourced from clinicaltrials.gov

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