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A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

An Open-Label Study of KW-2871 Administered With a Premedication Regimen in Patients With Advanced Stage IV Melanoma

NCT00199342•Kyowa Kirin, Inc.

Summary

This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be administered at 14-day intervals.

Detailed Description

This open label study consists of two parts. Part I, the Phase I component of the study, will be conducted at a single center, and will enroll up to 18 patients with histologically documented Stage IV melanoma (per the American Joint Committee on Cancer \[AJCC\] criteria) that is not currently amenable to surgical resection or other therapies. A specified premedication regimen consisting of ranitidine, diphenhydramine, and dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose of KW-2871. Planned doses of KW-2871 are 60 mg/m2, 80 mg/m2, 100 mg/m2 After identification of the MTD, 30 patients will be enrolled at that dose level in Part II of the study. If no MTD is identified after treatment with the 100 mg/m2 dose level, the dose administered in Part II of the study will be 100 mg/m2. If the MTD is determined as 60 mg/m2, this study will be closed to further patient accrual and will not proceed to Part II.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients \> 18 years of age
•2. Patients with documented Stage IV melanoma (histologically- or cytologically-proven, as per AJCC criteria) that is not currently amenable to surgical resection (due to either medical contraindication or non-resectability of tumor)
•3. Patients may have measurable or non-measurable disease, in accordance with the RECIST criteria.
•4. Failure of at least one, but no more than 3, standard treatment regimen(s) for metastatic disease
•5. Patients must have adequate end-organ function including:
•1. Hemoglobin \> 9.0 g/dL
•2. ANC \> 1500/mm3
•3. Platelet count \> 100,000/ mm3
•4. Serum creatinine \< 1.5x the upper limit of normal
•5. Total bilirubin \< 1.5 mg/dL
+7 more criteria

Exclusion Criteria

•1. Women who are pregnant or lactating and women of childbearing potential and fertile men not agreeing to a medically effective method of contraception. Women of childbearing potential will be informed as to the potential risk of procreation while participating in this study and will be advised that they must use effective contraception (e.g. oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) during the treatment period and for a period of 3 months following the completion of dosing.
•2. Patients with significant cardiovascular disease as defined by The New York Heart Association Classification (Class III or higher)
•3. Patients with symptomatic or known brain metastases unless patient has undergone radiotherapy (or treatment with gamma knife) or resection of an isolated lesion and maintenance steroids are not required
•4. Patients with a history of another malignancy within the last 2 years with the exception of:
•* Treated, non-melanoma skin cancers
•* Carcinoma in situ of the breast or cervix
•* History of T1a or b carcinoma of the prostate detected incidentally and comprising \<5% of resected tissue, with PSA within normal limits since resection
•5. Patients with any uncontrolled infection or other intercurrent illness
•6. Patients with any history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of an underlying disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
•7. Patients with known HIV infection
+7 more criteria

Locations (2)

Comprehensive Cancer Center- University of Alabama at Birmingham

Birmingham, Alabama, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

November 1, 2004

Primary Completion Date

October 1, 2005

Last Updated

May 3, 2024

Enrollment

ACTUAL participants

Conditions

Stage IV Melanoma

Interventions

KW-2871

DRUG

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

NCT05176470

Locally Advanced MelanomaPathologic Stage IIIB Cutaneous Melanoma AJCC v8+3 more

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WITHDRAWNPHASE1

Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

NCT02145910

Recurrent MelanomaStage IV Melanoma+1 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: May 3, 2024Data 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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A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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