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Phase II, 2nd Line Melanoma - RAND Monotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II, 2nd Line Melanoma - RAND Monotherapy

A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma

NCT00612664•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
•Men and women, who are at least 18 years of age

Exclusion Criteria

•Ocular or mucosal melanoma
•Complete surgical resection of all identifiable sites of disease

Locations (32)

The Angeles Clinic & Research Institute

Los Angeles, California, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Indiana University Melvin And Bren Simon Cancer Center

Indianapolis, Indiana, United States

Harry & Jeanette Weinberg Cancer Inst At Franklin Square

Baltimore, Maryland, United States

Dana-Farber Cancer Inst

Boston, Massachusetts, United States

Mem Sloan-Ket Can Ctr

New York, New York, United States

Blumenthal Cancer Center, Carolinas Medical Center

Charlotte, North Carolina, United States

Providence Portland Medical Center

Portland, Oregon, United States

University Of Texas

Houston, Texas, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

October 1, 2009

Completion Date

October 1, 2009

Last Updated

October 12, 2015

Enrollment

158

ACTUAL participants

Conditions

Melanoma

Interventions

Anti-CD137 (4-1BB) (BMS-663513)

DRUG

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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RECRUITINGPHASE1

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II, 2nd Line Melanoma - RAND Monotherapy

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers