Loading clinical trials...

Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases

NCT00623766•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed malignant melanoma
•At least 1 measurable index brain metastasis \>0.5 cm and no larger than 3 cm in diameter that had not been previously irradiated, and/or 2 measurable lesions \>0.3 cm visible on contrast magnetic resonance
•Index brain lesion must have resolved consequences of prior therapy that could have confounded attribution of tumor response including edema and hemorrhage
•Participants in ipilimumab monotherapy arm (including the first 21 who were enrolled in Stage 1) were to be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 10 days prior to beginning ipilimumab therapy
•Eastern Cooperative Oncology Group performance status of 0 or 1
•Required values for initial laboratory tests:
•* White blood cell count ≥2000/μL
•* Absolute neutrophil count ≥1000/μL
•* Platelets ≥100\*10\^3/μL
•* Hemoglobin level ≥9 g/dL (may have been transfused)
+6 more criteria

Exclusion Criteria

•History of carcinomatous meningitis, with prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days before the first dose of ipilimumab, and documented history of autoimmune disease
•Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days prior to start of ipilimumab dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion or the lesion must have been detected and confirmed to be active and progressing after receiving whole brain irradiation.

Locations (14)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

City Of Hope

Duarte, California, United States

The Angeles Clinic & Research Institute

Los Angeles, California, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Loyola University Medical Center

Maywood, Illinois, United States

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

September 1, 2009

Completion Date

October 1, 2012

Last Updated

June 9, 2014

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

Ipilimumab

DRUG

Corticosteroid: Betamethasone

DRUG

Corticosteroid: Dexamethasone

DRUG

Corticosteroid: Fludrocortisone

DRUG

Corticosteroid: Hydrocortisone

DRUG

Corticosteroid: Meprednisone

DRUG

Corticosteroid: Methylprednisolone

DRUG

Corticosteroid: Prednisolone

DRUG

Corticosteroid: Prednisone

DRUG

Corticosteroid: Triamcinolone

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

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

View study

RECRUITINGPHASE1

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

View study

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: June 9, 2014Data 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.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

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