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A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

Phase 1
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung, Colorectal Cancer, Malignant Melanoma, Renal Cancer, Prostate Cancer

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Trial Information

A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies

Six patients will be enrolled at each dose level of 0.3, 1.0, 3.0 and 10mg/kg; the remaining
10 to 15 patients may subsequently be enrolled at a dose at or below the maximum tolerated
dose (MTD) during the dose-escalation portion of the study. Patients who respond may receive
additional doses of drug.

Inclusion Criteria:

- Relapsed/refractory non-small cell lung cancer, colorectal adenocarcinoma, malignant
melanoma, renal (clear) cell carcinoma, or hormone-refractory prostate adenocarcinoma

- Prior treatment must have been completed at least 4 weeks prior to enrollment

- No untreated primary or metastatic brain or meningeal tumors

- ECOG PS 0 or 1

- Meet all screening laboratory values

Exclusion Criteria:

- History of severe hypersensitivity reactions to other monoclonal antibodies

- No active autoimmune disease or a documented history of autoimmune disease

- No prior therapy with an anti-PD-1 or anti-CTLA-4 antibody

- No active infection

- No concomitant immunosuppressive medications

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

incidence and severity of treatment-emergent adverse events

Outcome Time Frame:

if they occur, they will be monitored through resolution of the event

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

November 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Cancer
  • Malignant Melanoma
  • Renal Cancer
  • Prostate Cancer
  • malignancies
  • cancer
  • non small cell lung cancer
  • lung cancer
  • colorectal cancer
  • adenocarcinoma
  • melanoma
  • malignant melanoma
  • renal cancer
  • renal carcinoma
  • carcinoma
  • prostate cancer
  • prostate adenocarcinoma
  • Recurrent or treatment refractory malignancies
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms
  • Melanoma
  • Prostatic Neoplasms



Henry Ford Health System Detroit, Michigan  48202
Carolina BioOncology Institute, PLLC Huntersville, North Carolina  28078
Johns Hopkins Unv., School of Medicine Baltimore, Maryland  21231
Washington University School of Medicine - Barnes Jewish Hospital St. Louis, Missouri  63110