A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years of age

Confirmed histologic diagnosis of metastatic TNBC

1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.

Physically fit (clinically eligible) to undergo cryoablation as per usual clinical practice

Disqualifiers

Patient not eligible for PD-1 inhibitor per the patient's medical oncologist

No disease amenable for cryoablation

Pembrolizumab therapy not planned as part of standard of care

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Pembrolizumab + CryoablationExperimental treatment 2 interventions
Group B: PembrolizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in CD4-PD1 from baseline to post-cryoablation

Assess changes in CD4-PD1 in the blood after cryoablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).

Time frame
6 weeks after cryoablation

Secondary outcomes

Other outcomes

Sponsors and contacts

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