A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies (MDX1106-01)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Malignant Melanoma; Renal Cancer; Carcinoma, Non-Small-Cell Lung; Prostate Cancer; Colorectal Cancer

Treatments: Biological: MDX-1106

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441337

MDX1106-01 (Other Identifier)

CA209-001 ST

Details and patient eligibility

About

To evaluate the safety, tolerability, efficacy, and pharmacokinetics of MDX-1106 when administered to patients with advanced non-small cell lung cancer, colorectal cancer, malignant melanoma, clear cell renal cell cancer or hormone refractory prostate cancer

Full description

Six patients 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Active autoimmune disease or a documented history of autoimmune disease
• Prior therapy with an anti-PD-1 or anti-CTLA-4 antibody
• Active infection
• Concurrent medical condition requiring the use of immunosuppressive medications

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 4 patient groups

0.3 mg/kg MDX-1106 drug

Experimental group

Description:

0.3 milligrams (mg) MDX-1106 drug (nivolumab) per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).

Treatment:

Biological: MDX-1106

1 mg/kg MDX-1106 drug

Experimental group

Description:

1 mg MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).

Treatment:

Biological: MDX-1106

3 mg/kg MDX-1106 drug

Experimental group

Description:

3 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).

Treatment:

Biological: MDX-1106

10 mg/kg MDX-1106 drug

Experimental group

Description:

10 mgs MDX-1106 drug (nivolumab) per kg of body weight (mg/kg) was administered in a single IV infusion. If criteria were met, 2 additional doses could be administered (1 every 4 weeks).

Treatment:

Biological: MDX-1106