Phase I Clinical Trial of Tremelimumab Plus MEDI3617 in Patients With Unresectable Stage III or Stage IV Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
F. Stephen Hodi, MD
Study ID
NCT02141542
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is an open label, phase I trial, testing the combination of Tremelimumab and MEDI3617 in patients with metastatic melanoma.

Key Dates

Start date
May 31, 2014
Status verified
Apr 2023
Primary completion
Sep 23, 2020
Completion
Sep 23, 2020

Study Design

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

Arms

  • Experimental: Tremelimumab and MEDI3617
    * Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Tremelimumab-Fixed doses of Tremelimumab are given once per cycle * MEDI3617-MEDI3617 is administered twice per cycle

Primary Outcome Measure

Determination of the maximum tolerated dose (MTD) of the combination of tremelimumab and MEDI3617 [ Time Frame: 2 Years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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