A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

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

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06246968
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Participants will receive Pembrolizumab as part of standard of care treatment.
  • Cryoablation — DEVICE
    Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.

Study Details

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

Key Dates

Start date
Jan 29, 2024
Status verified
May 2026
Primary completion
Jan 29, 2027
Completion
Jan 29, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Cryoablation
    Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).
  • Active Comparator: Pembrolizumab
    Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).

Primary Outcome Measure

Change in CD4-PD1 from baseline to post-cryoablation [ Time Frame: 6 weeks after cryoablation ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Yolanda Bryce, MD
212-639-6530
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Yolanda Bryce, MD
212-639-6530
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Yolanda Bryce, MD
212-639-6530
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )CommackNew York11725
Yolanda Bryce, MD
212-639-6530
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Yolanda Bryce, MD
212-639-6530
Memorial Sloan Kettering Cancer Center (All protocol activites)New YorkNew York10065
Yolanda Bryce, MD
212-639-6530
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Yolanda Bryce, MD
212-639-6530

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All protocol activites)· New York, NY

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