IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT03958383
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • hu14.18-IL2 — BIOLOGICAL
    A recombinant fusion protein linking the monoclonal antibody (mAb) hu14.18 with interleukin-2 (IL2), administered IT
  • Radiation Therapy — RADIATION
    Palliative radiation therapy
  • Nivolumab — BIOLOGICAL
    Human programmed death receptor (PD-1) blocking antibody, given IV
  • Ipilimumab — BIOLOGICAL
    Monoclinal antibody that targets cytoxic T-lymphocyte-associated protein 4 (CTLA-4), given IV

Study Details

This phase I/II trial is designed to determine the maximum tolerated dose or the maximum administered dose of intratumoral administration of hu14.18-IL2 and to evaluate side effects of intratumoral hu14.18-IL2 when given alone, after radiation therapy, after radiation therapy and in combination with nivolumab, and after radiation therapy and in combination with nivolumab and ipilimumab in patients with melanoma that is advanced (stage IV) or with melanoma that cannot be removed by surgery and is considered surgically incurable. Hu14.18-IL2 is a molecule called a fusion protein that can bind to some tumor cells and cause immune cells to become activated to kill tumor cells. Radiation therapy is a type of cancer treatment that uses beams of high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with immune checkpoint inhibitors, such as nivolumab and ipilimumab, can help the body's immune system attack cancer by releasing the "brakes" on the immune system to allow cancer fighting immune cells to remain activated. This study will evaluate whether giving intratumoral hu14.18-IL2 with radiation therapy, nivolumab and ipilimumab has antitumor activity for participants with advanced melanoma. After completion of study treatment, participants are followed up at 30 days, every 12 weeks for up to 2 years, and then every 6 months thereafter.

Key Dates

Start date
Jan 30, 2020
Status verified
May 2026
Primary completion
Jan 6, 2024
Completion
Dec 9, 2025

Study Design

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

Arms

  • Experimental: Experimental Groups
    PHASE IA: As described above. Participants receive hu14.18-IL2 fusion protein intratumorally (IT). PHASE IB: As described above. Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA. PHASE IC: As described above. Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA. PHASE ID: As described above. Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

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Find similar trials in Madison, WI

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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