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Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

Primary Purpose

Renal Cell Carcinoma, Non-hodgkin's Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDX-1203
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

  • Criteria specific to each tumor type:

    • For Clear cell renal cell carcinoma (ccRCC): advanced or recurrent disease. Must have failed at least 1 prior systemic therapy
    • For B-cell non-Hodgkin's lymphoma (B-NHL): Must have failed at least 1 prior systemic therapy

  • Measurable disease criteria by tumor type:

    • For ccRCC: At least 1 unidimensional measurable lesion
    • For B-NHL: At least 1 bidimensionally measurable lesion
  • Prior therapies for advanced/recurrent ccRCC or relapsed/refractory B-NHL or have become intolerant to a systemic therapy
  • Provide archived or fresh tumor tissue for CD70 status. Subjects must be CD70+
  • Provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 B-NHL subjects

Exclusion Criteria:

  • Prior therapy with an anti-CD70 antibody
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • Active or untreated central nervous system lymphoma
  • Active infection (viral, bacterial, or fungal)
  • Evidence of bleeding diathesis or coagulopathy
  • Active autoimmune disease requiring immunosuppressive therapy
  • Known current drug or alcohol abuse

Sites / Locations

  • Yale University School of Medicine
  • Emory University Winship Cancer Center
  • The University of Chicago
  • University of Maryland Greenebaum Cancer Center
  • The University of Michigan Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDX-1203

Arm Description

Accelerated titration design (ATD)of 6 dose levels. Subjects will be assigned to a dose level in the order they enter the study

Outcomes

Primary Outcome Measures

Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)

Secondary Outcome Measures

Biomarker: Incidence of CD70+ tumors in target population

Full Information

First Posted
July 22, 2009
Last Updated
May 21, 2013
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00944905
Brief Title
Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)
Official Title
A Phase I, Multicenter, Open-Label, Dose-Escalation, Multidose Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma or Relapsed/Refractory B-Cell Non Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.
Detailed Description
Multicenter, open-label, dose-escalation, multidose study of MDX-1203, a fully human monoclonal antibody drug conjugate targeting the CD70 transmembrane cell-surface protein which is highly expressed in ccRCC and B-NHL. MDX-1203 is composed of a human anti-CD70 monoclonal antibody covalently linked to a prodrug form of a cytotoxic deoxyribonucleic acid (DNA) minor-groove binding agent (MGBA). The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 17 cycles or 2 years), and Follow-up (up to 6 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Non-hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MDX-1203
Arm Type
Experimental
Arm Description
Accelerated titration design (ATD)of 6 dose levels. Subjects will be assigned to a dose level in the order they enter the study
Intervention Type
Biological
Intervention Name(s)
MDX-1203
Intervention Description
Assigned Interventions: Single dose of MDX-1203 will be administered every 21 days as an intravenous (i.v.) infusion. Subjects will receive one dose of MDX-1203.
Primary Outcome Measure Information:
Title
Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)
Time Frame
up to 17 cycles
Secondary Outcome Measure Information:
Title
Biomarker: Incidence of CD70+ tumors in target population
Time Frame
Screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 Criteria specific to each tumor type: For Clear cell renal cell carcinoma (ccRCC): advanced or recurrent disease. Must have failed at least 1 prior systemic therapy For B-cell non-Hodgkin's lymphoma (B-NHL): Must have failed at least 1 prior systemic therapy Measurable disease criteria by tumor type: For ccRCC: At least 1 unidimensional measurable lesion For B-NHL: At least 1 bidimensionally measurable lesion Prior therapies for advanced/recurrent ccRCC or relapsed/refractory B-NHL or have become intolerant to a systemic therapy Provide archived or fresh tumor tissue for CD70 status. Subjects must be CD70+ Provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 B-NHL subjects Exclusion Criteria: Prior therapy with an anti-CD70 antibody History of severe hypersensitivity reactions to other monoclonal antibodies Active or untreated central nervous system lymphoma Active infection (viral, bacterial, or fungal) Evidence of bleeding diathesis or coagulopathy Active autoimmune disease requiring immunosuppressive therapy Known current drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Emory University Winship Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

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