CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05289193
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • PET Scan — DIAGNOSTIC_TEST
    Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.
  • Nivolumab — DRUG
    Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg.
  • Ipilimumab — DRUG
    Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg.
  • Surgical Resection of Melanoma — PROCEDURE
    Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.

Study Details

Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.

Key Dates

Start date
Mar 11, 2022
Status verified
Apr 2026
Primary completion
Mar 11, 2027
Completion
Mar 11, 2027

Study Design

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

Arms

  • Experimental: Participants with Stage III Melanoma
    All participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed.

Primary Outcome Measure

Major pathologic responses/MPR [ Time Frame: up to 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-

Find similar trials in Basking Ridge, NJ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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