Know Cancer

forgot password

A Phase 1/2, Multi-Center, Blinded, Randomized, Controlled Study of the Safety and Efficacy of the Human Monoclonal Antibody to Human α ν Integrins (CNTO 95), Alone and in Combination With Dacarbazine, in Subjects With Stage IV Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Melanoma Stage IV

Thank you

Trial Information

A Phase 1/2, Multi-Center, Blinded, Randomized, Controlled Study of the Safety and Efficacy of the Human Monoclonal Antibody to Human α ν Integrins (CNTO 95), Alone and in Combination With Dacarbazine, in Subjects With Stage IV Melanoma

This is a Phase 1/2, multi-center, randomized (the study medication is assigned by chance)
study. This study is conducted in 2 Phases (Phase 1 and Phase 2). Phase 1 of this study is
nonrandomized, open-label (all people know the identity of the intervention),
dose-escalation phase. It includes screening period and treatment period, which consists of
2 parts (Part 1 and Part 2). In Part 1, patients will receive 1 of 3 single dose levels of
CNTO 95 [3 mg/kg, 5 mg/kg, or 10 mg/kg]. Part 2 will include 2 dose cohorts, Cohort 1:
dacarbazine (DTIC) plus CNTO 95 [5 mg/kg] and Cohort 2: DTIC plus CNTO 95 [10 mg/kg]. Phase
2 of this study is randomized, blinded (neither physician nor patient knows the intervention
which the patient will receive nor any 1 of them does not know the intervention), and
controlled (an inactive substance and other medication is compared with a study medication
to test whether the medication has a real effect in this clinical study). This phase of the
study includes screening period, treatment period (8 cycles of treatment with every cycle
once in 3 weeks), and follow-up period (24 weeks). During the treatment period, patients
will be randomly assigned to 1 of 4 treatment groups, Group 1: DTIC plus placebo, Group 2:
CNTO 95 (5 mg/kg), Group 3: CNTO 95 (10 mg/kg), and Group 4: DTIC plus CNTO 95.
Randomization will be further based on the site of metastases at baseline and baseline
Eastern Cooperative Oncology Group performance status. Single-medication CNTO 95 treatment
groups will be open-label, while the DTIC plus CNTO 95 or placebo groups will be blinded.
The total duration of the Phase 2 of this study is up to 52 weeks or up to 76 weeks in case
of extended dosing (extended administrations [up to 8 additional cycles] of the same
assigned treatment will be allowed for patients that are responding to therapy with stable
disease or better). Safety evaluations will include adverse events, infusion reactions,
clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Inclusion Criteria:

- Histologically confirmed melanoma including ocular and mucosal (Stage III
unresectable or Stage IV)

- Radiographically measurable disease or measurable skin lesions

- Prior chemotherapy for metastatic melanoma will be allowed for Phase 1, while
previously untreated for melanoma by chemotherapy will be allowed for Phase 2

- Agrees to protocol-defined use of effective contraception

- Adequate values of bone marrow, liver function tests, and renal function tests

Exclusion Criteria:

- History of receiving murine or human/murine recombination products of human αν

- Known human immunodeficiency virus (HIV) positivity and clinically important active

- Presence of bone metastases or malignant effusions (non measurable lesions) only and
presence of central nervous system metastases

- Prior radiation to target lesions

- Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational
therapy and therapeutic use of anticoagulation

- History of bleeding diathesis, recurrent deep vein thrombosis and uveitis

- Planned surgery (except for minor surgical procedures) during study period

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I (Part 1): Incidence of dose limiting toxicities (DLTs)

Outcome Description:

Incidence of DLTs when a single-agent CNTO 95 (3 mg/kg, 5 mg/kg, or 10 mg/kg) will be administered to patients. DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to CNTO 95 except for hypersensitivity reactions, which will not be considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity. reaction within a cohort.

Outcome Time Frame:

Up to 21 days post first infusion from the last treated patient in Part 1 of Phase I

Safety Issue:


Principal Investigator

Centocor, Inc Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Centocor, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

February 2009

Related Keywords:

  • Melanoma Stage IV
  • Melanoma Stage IV
  • Cancer
  • CNTO 95
  • Dacarbazine
  • Intetumumab
  • Human Monoclonal Antibody
  • Melanoma



Hinsdale, Illinois  60521
Albany, Georgia  31701
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Omaha, Nebraska  68114
Denver, Colorado  
Indianapolis, Indiana  
Washington, District of Columbia