Trial Outcomes & Findings for Study to Assess the Efficacy of Pembrolizumab Plus Radiotherapy in Metastatic Triple Negative Breast Cancer Patients (NCT NCT02730130)

NCT ID: NCT02730130

Last Updated: 2022-10-19

Results Overview

RECIST v. 1.1 criteria will be used.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2022-10-19

Participant Flow

Participant milestones

Measure	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. Pembrolizumab Radiotherapy
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pembrolizumab Plus Radiotherapy n=17 Participants 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. Pembrolizumab Radiotherapy
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

RECIST v. 1.1 criteria will be used.

Outcome measures

Measure	Pembrolizumab Plus Radiotherapy n=17 Participants 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. Pembrolizumab Radiotherapy
Overall Response Rate in Unirradiated Lesions Complete Response	3 Participants
Overall Response Rate in Unirradiated Lesions Partial Response	0 Participants
Overall Response Rate in Unirradiated Lesions Stable Disease	1 Participants
Overall Response Rate in Unirradiated Lesions Progressive Disease	8 Participants
Overall Response Rate in Unirradiated Lesions Not Evaluable	5 Participants

SECONDARY outcome

Timeframe: 13 weeks

Only participants with a Complete Response and a Partial Response will be evaluated.

Outcome measures

Measure

Pembrolizumab Plus Radiotherapy n=3 Participants 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. Pembrolizumab Radiotherapy

Duration of Response

4.5 months Interval 4.1 to 8.3

SECONDARY outcome

Timeframe: 13 weeks

Only participants with a Complete Response and a Partial Response will be evaluated.

Outcome measures

Measure

Pembrolizumab Plus Radiotherapy n=3 Participants 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. Pembrolizumab Radiotherapy

Time to Response

2.8 months Interval 2.7 to 3.0

Adverse Events

Pembrolizumab Plus Radiotherapy

Serious events: 17 serious events

Other events: 17 other events

Deaths: 15 deaths

Serious adverse events

Measure	Pembrolizumab Plus Radiotherapy n=17 participants at risk 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. Pembrolizumab Radiotherapy
Respiratory, thoracic and mediastinal disorders Dyspnea	17.6% 3/17 • 1 year
General disorders Fatigue	29.4% 5/17 • 1 year
Investigations Alanine aminotransferase increased	5.9% 1/17 • 1 year
Vascular disorders Thromboembolic event	5.9% 1/17 • 1 year
Gastrointestinal disorders Diarrhea	11.8% 2/17 • 1 year
Investigations Platelet Count Decreased	5.9% 1/17 • 1 year
Investigations Blood bilirubin increased	5.9% 1/17 • 1 year
General disorders Fever	11.8% 2/17 • 1 year
Psychiatric disorders Insomnia	5.9% 1/17 • 1 year
Infections and infestations Soft tissue infection	5.9% 1/17 • 1 year

Other adverse events

Measure	Pembrolizumab Plus Radiotherapy n=17 participants at risk 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. Pembrolizumab Radiotherapy
Infections and infestations Infection	5.9% 1/17 • 1 year
Investigations Lymphopenia	11.8% 2/17 • 1 year
Hepatobiliary disorders Biliary obstruction	5.9% 1/17 • 1 year
Investigations Bilirubinemia	5.9% 1/17 • 1 year
Injury, poisoning and procedural complications Radiation Dermatitis	5.9% 1/17 • 1 year
General disorders Fatigue	11.8% 2/17 • 1 year
Skin and subcutaneous tissue disorders Skin Changes	11.8% 2/17 • 1 year
Gastrointestinal disorders Nausea	11.8% 2/17 • 1 year
Investigations ALT increased	5.9% 1/17 • 1 year
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • 1 year
Gastrointestinal disorders Colitis	5.9% 1/17 • 1 year
Gastrointestinal disorders Diarrhea	5.9% 1/17 • 1 year
Skin and subcutaneous tissue disorders Dry Skin	5.9% 1/17 • 1 year
Endocrine disorders Hypothyroidism	5.9% 1/17 • 1 year
Injury, poisoning and procedural complications Infusion related reaction	5.9% 1/17 • 1 year
General disorders Localized edema	5.9% 1/17 • 1 year
Skin and subcutaneous tissue disorders Pruritus	5.9% 1/17 • 1 year

Additional Information

Christopher Barker, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-8168

Email: barkerc@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place