A Phase 1, Open Label, Dose-escalation, Safety and Pharmacokinetic Study of MDX-1106 in Patients With Selected or Relapsed Malignancies
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung, Colorectal Cancer, Malignant Melanoma, Renal Cancer, Prostate Cancer
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:
Interventional
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:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
MDX1106-01
NCT ID:
NCT00441337
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
Name | Location |
|---|---|
| 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 |
