A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer – (KEYNOTE-355) - A Phase III Study of Chemotherapy ± Pembrolizumab in 1L Triple Negative Breast Cancer

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites858 target enrollmentSeptember 2, 2016

DrugsGemcitabine Paclitaxel Carboplatin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 858
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 2, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\.Have locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent.
•Have metastatic breast cancer not previously treated with chemotherapy.
•Note: Subjects with a history of locally recurrent breast cancer, which was previously treated with curative intent, may be eligible.
•2\.Have centrally confirmed TNBC, as defined by the most recent ASCO/CAP guidelines.
•Note: Subjects initially diagnosed with hormone receptor–positive and/or HER2 positive breast cancer must have central confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
•3\.Have completed treatment for Stage I\-III breast cancer, if indicated, and \=6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
•Note: Adjuvant radiation therapy is not considered treatment with curative intent for the purpose of calculating the \=6 month interval requirement described above.
•Note: First documentation of local or distant disease recurrence must be in the form of a dated biopsy, pathology, or imaging study report. A laboratory report indicating tumor marker elevation cannot be used as documentation of local or distant disease recurrence, unless accompanied by dated biopsy, pathology, or imaging study report.
•Note: Subjects who received taxane, gemcitabine, or platinum agents in the (neo)adjuvant setting can be treated with same class of chemotherapy (taxane or gemcitabine/carboplatin), if \=12 months have elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
•4\.Have been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the subject in the opinion of the treating physician.

Exclusion Criteria

•1\.Is currently participating in a clinical study and receiving an investigational agent and/or using an investigational device, or has participated in a clinical study and received an investigational agent and/or used an investigational device within 4 weeks prior to randomization.
•Note: Subjects who have entered the follow\-up phase of a clinical study may participate as long as 4 weeks have elapsed since the last dose of the investigational agent and/or removal of the device.
•Note: Subjects who were treated with radiation therapy may participate as long as at least 2 weeks have elapsed since the last dose of radiation therapy was administered.
•2\.Has not recovered (e.g., to \=Grade 1 or to baseline) from AEs due to a previously administered therapy.
•Note: Alopecia of any grade is an exception to this criterion.
•Note: Prior to randomization, the subject must have recovered adequately from any toxicity and/or complications associated with any recent procedure.
•3\.Has neuropathy \=Grade 2\.
•4\.Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
•5\.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
•6\.Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.