NCT02730130

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

Completed Phase 2 Results posted Last updated 19 October 2022

What this trial tests

Phase 2 trial testing Pembrolizumab in Breast Cancer in 17 participants. Completed in 12 October 2022.

Timeline

3 June 2016

Primary endpoint
26 September 2017

12 October 2022

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	3 June 2016
Primary completion	26 September 2017
Estimated completion	12 October 2022
Sites	7 locations across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Radiotherapy — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Metastatic Triple Negative — all drugs for Metastatic Triple Negative →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Breast Cancer or Metastatic Triple Negative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate in Unirradiated Lesions Primary · 13 weeks

RECIST v. 1.1 criteria will be used.

Group	Value	95% CI
Pembrolizumab Plus Radiotherapy	3
Pembrolizumab Plus Radiotherapy	0
Pembrolizumab Plus Radiotherapy	1
Pembrolizumab Plus Radiotherapy	8

Duration of Response Secondary · 13 weeks

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

Group	Value	95% CI
Pembrolizumab Plus Radiotherapy	4.5	4.1 – 8.3

Time to Response Secondary · 13 weeks

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

Group	Value	95% CI
Pembrolizumab Plus Radiotherapy	2.8	2.7 – 3.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pembrolizumab Plus Radiotherapy

Serious: 17/17 (100%)

Deaths: 15/17

Serious adverse events (10 terms)

Reaction	System	Pembrolizumab Plus Radioth…
Fatigue	General disorders	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Fever	General disorders	—
Alanine aminotransferase increased	Investigations	—
Thromboembolic event	Vascular disorders	—
Platelet Count Decreased	Investigations	—
Blood bilirubin increased	Investigations	—
Insomnia	Psychiatric disorders	—
Soft tissue infection	Infections and infestations	—

Other adverse events (17 terms — click to expand)

Reaction	System	Pembrolizumab Plus Radioth…
Lymphopenia	Investigations	—
Fatigue	General disorders	—
Skin Changes	Skin and subcutaneous tissue disorders	—
Nausea	Gastrointestinal disorders	—
Infection	Infections and infestations	—
Biliary obstruction	Hepatobiliary disorders	—
Bilirubinemia	Investigations	—
Radiation Dermatitis	Injury, poisoning and procedural complications	—
ALT increased	Investigations	—
Alopecia	Skin and subcutaneous tissue disorders	—
Colitis	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Dry Skin	Skin and subcutaneous tissue disorders	—
Hypothyroidism	Endocrine disorders	—
Infusion related reaction	Injury, poisoning and procedural complications	—
Localized edema	General disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Fatigue, Dyspnea, Diarrhea, Fever, Alanine aminotransferase increased, Thromboembolic event, Platelet Count Decreased, Blood bilirubin increased.

Data from ClinicalTrials.gov NCT02730130 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
2. Abscopal effect of radiotherapy combined with immune checkpoint inhibitors.
   Liu Y, Dong Y, Kong L, Shi F, et al · · 2018 · cited 337× · PMID 30115069 · DOI 10.1186/s13045-018-0647-8
3. Current Landscape of Immunotherapy in Breast Cancer: A Review.
   Adams S, Gatti-Mays ME, Kalinsky K, Korde LA, et al · · 2019 · cited 297× · PMID 30973611 · DOI 10.1001/jamaoncol.2018.7147
4. Current clinical trials testing the combination of immunotherapy with radiotherapy.
   Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
5. Mechanisms of immune evasion in breast cancer.
   Bates JP, Derakhshandeh R, Jones L, Webb TJ. · · 2018 · cited 206× · PMID 29751789 · DOI 10.1186/s12885-018-4441-3
6. Combining Immune Checkpoint Inhibitors With Conventional Cancer Therapy.
   Yan Y, Kumar AB, Finnes H, Markovic SN, et al · · 2018 · cited 163× · PMID 30100909 · DOI 10.3389/fimmu.2018.01739
7. Novel Approaches to Improve the Efficacy of Immuno-Radiotherapy.
   Shevtsov M, Sato H, Multhoff G, Shibata A. · · 2019 · cited 137× · PMID 30941308 · DOI 10.3389/fonc.2019.00156
8. Targeting immune checkpoints in breast cancer: an update of early results.
   Solinas C, Gombos A, Latifyan S, Piccart-Gebhart M, et al · · 2017 · cited 122× · PMID 29177095 · DOI 10.1136/esmoopen-2017-000255