Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03449238
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.

Study Details

Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.

Key Dates

Start date
Nov 15, 2018
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

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

Arms

  • Other: Pembrolizumab and SRS
    Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.

Primary Outcome Measure

Tumor response for non-irradiated brain lesions at 8 weeks according to RECIST1.1 [ Time Frame: 8 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brooklyn Methodist Hospital - NewYork PresbyterianNew YorkNew York11215
Izael Nino, M.S.
[email protected]
929-470-9426
Hani Ashamalla, M.D. (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital - QueensNew YorkNew York11355
Krystalle Lyons, B.S.
[email protected]
Andrew Brandmaier, M.D. (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Fabiana Gregucci, M.D.
[email protected]
646-962-3110

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Brooklyn Methodist Hospital - NewYork Presbyterian· New York, NYNew York Presbyterian Hospital - Queens· New York, NYWeill Cornell Medicine· New York, NY

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