A Multicenter Single Arm Phase II Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients

Memorial Sloan Kettering Cancer Center7 sites in 1 country17 target enrollmentJune 3, 2016

ConditionsBreast Cancer Metastatic Triple Negative

InterventionsPembrolizumab Radiotherapy

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 17
Locations: 7
Primary Endpoint: Overall Response Rate in Unirradiated Lesions
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, pembrolizumab has on the patient and areas of cancer in their body that did not receive radiation therapy.

Registry

clinicaltrials.gov

Start Date

June 3, 2016

End Date

October 12, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Be willing and able to provide written informed consent/assent for the trial.
•Be female ≥ 18 years of age on day of signing informed consent.
•Histologically or cytologically-confirmed TNBC (defined as ER \<1%, PR \<1%, her-2-neu 0-1+ by IHC or FISH-negative or as per MD discretion) at each enrolling institution.
•Metastatic or locally recurrent TNBC.
•Subjects who are resistant to conventional chemotherapy or have declined conventional therapy for TNBC. Patients having received any prior line of systemic therapy for inoperable/recurrent or metastatic disease are eligible.
•At least one tumor for which palliative RT is considered appropriate standard therapy.
•At least one index lesion that will not undergo RT and which is measurable based on RECIST 1.
•If an archived tumor tissue is available, be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1 of RT.
•Repeat palliative RT will be permitted for the treatment of isolated, non-target lesions.
•Consent for blood draws for research purposes.

Exclusion Criteria

•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•Has a known history of active TB (Bacillus Tuberculosis)
•Hypersensitivity to pembrolizumab or any of its excipients.
•Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≥ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≥ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Has a known additional malignancy that progressed or required treatment in the last 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain parenchymal metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.

Arms & Interventions

Pembrolizumab Plus Radiotherapy

Subjects will receive pembrolizumab 200 mg as an IV infusion. RT begins D1 prior to dose 1 of Pembrolizumab. Pembrolizumab will be administered as a 30 minute IV infusion. Radiotherapy will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice. The dose of radiation will be a standard regimen/fractionation used in palliation: 3000 cGy, delivered in five 600 cGy fractions within 5-7 days.

Intervention: Pembrolizumab