Cryoablation+Ipilimumab+Nivolumab in Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05779423
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Monoclonal antibody administered through intravenous infusion
  • Nivolumab — DRUG
    Monoclonal antibody administered through intravenous infusion
  • Cryoablation — PROCEDURE
    Procedure of freezing a tumor performed via CT-guidance by interventional radiologist.

Study Details

The aim of this study is to find out whether the combination of two approved drugs, ipilimumab and nivolumab, in combination with cryoablation are safe and effective for participants who have an unresectable melanoma that is resistant, or is growing, after receiving immunotherapy with a PD-1 inhibitor. The names of the study interventions involved in this study are: * Cryoablation (an interventional radiology procedure that freezes part of a tumor) * Ipilimumab (an immunotherapy) * Nivolumab (an immunotherapy)

Key Dates

Start date
Sep 23, 2023
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + Nivolumab + Cryoablation
    Study will be conducted in two stages: Stage 1: Will enroll 15 participants, and if 6 or more have clinical benefit, the study will proceed to Stage 2. * Baseline CT scan. * Cycle 1-4: Pre-determined doses of ipilimumab and nivolumab. Medications administered under direction of treating oncologist. * Day 2 - 14: Core Needle Biopsy followed by cryoablation between Cycle 1 - 2 * Surveillance CT scan at weeks 8 - 12, weeks 16 - 24. * Follow up for 6 months to assess safety after cryoablation. Participants followed for duration of response. Stage 2: Will enroll 22 participants * Baseline CT scan. * Cycle 1-4: Pre-determined doses of ipilimumab and nivolumab. Medications administered under direction of treating oncologist. * Day 2- 14: Core Needle Biopsy followed by cryoablation between Cycle 1 - 2. * Surveillance CT scan at weeks 8 - 12, weeks 16 - 24 * Follow up period to assess safety 6 months after cryoablation. Patients followed for duration of response.

Primary Outcome Measure

Rate of Clinical Benefit [ Time Frame: 6 months post-1st cryoablation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Meghan J Mooradian, MD
[email protected]
617-724-4000
Meghan J Mooradian, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
MelanomaSkin cancer
By specialty
OncologySkin cancerDermatology
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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