Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT01103635
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD40 agonist monoclonal antibody CP-870,893 — BIOLOGICAL
    Given IV
  • tremelimumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody CP-870,893, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving tremelimumab together with CD 40 agonist monoclonal antibody CP-870, 893 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving tremelimumab together with CD40 agonist monoclonal antibody CP-870,893 in treating patients with metastatic melanoma.

Key Dates

Start date
Feb 28, 2010
Status verified
Apr 2020
Primary completion
May 31, 2016
Completion
May 2, 2016

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive tremelimumab over 1 hour on day 1 and CD40 agonist monoclonal antibody CP-870,893 IV over 30 minutes on days 2, 22, 43, and 64. Treatment repeats every 12 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Toxicity as assessed by CTCAE v3.0 [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of The University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Abramson Cancer Center of The University of Pennsylvania· Philadelphia, PA

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