Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients

NCT02730130 | Completed Phase 2 Results

• 1 other identifier: 16-032
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer; Metastatic Triple Negative

Keywords

Pembrolizumab; Radiotherapy; 16-032

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate in Unirradiated Lesions

  RECIST v. 1.1 criteria will be used.

  13 weeks

Secondary Outcomes (2)

• Duration of Response

  13 weeks

• Time to Response

  13 weeks

Study Arms (1)

Pembrolizumab Plus Radiotherapy

EXPERIMENTAL

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.

Drug: Pembrolizumab; Radiation: Radiotherapy

Interventions

Pembrolizumab DRUG

Pembrolizumab Plus Radiotherapy

Radiotherapy RADIATION

Pembrolizumab Plus Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• 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.
• Consent for use of available archived tissue for research purposes.
• Have a performance status of 0 or 1 on the ECOG Performance Scale.
• Demonstrate adequate organ function; all screening labs should be performed within 28 days (+7 days) of treatment initiation, unless otherwise indicated.
• Hematological
• Absolute neutrophil count (ANC) ≥1.5, k/mcL

You may not qualify if:

• 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.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has known history of/active, non-infectious pneumonitis requiring treatment with steroids or has history of/active interstitial lung disease.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Merck Sharp & Dohme LLC: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (7)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pembrolizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Christopher Barker, MD
• Organization: Memorial Sloan Kettering Cancer Center

barkerc@mskcc.org

212-639-8168

Study Officials

• Christopher Barker, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 6, 2016
• Study Start: June 3, 2016
• Primary Completion: September 26, 2017
• Study Completion: October 12, 2022
• Last Updated: October 19, 2022
• Results First Posted: October 4, 2019

Record last verified: 2022-10

Locations

US (7)