A Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer.

Phase 1

• Conditions: Metastatic Triple Negative Breast Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001020-27-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1.Have received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on the most recent therapy.
2.Have been previously treated with an anthracycline and/or taxane in the (neo)adjuvant or metastatic setting.
3.Have centrally confirmed mTNBC (determined by a newly obtained core or excisional biopsy from a metastatic, not previously irradiated, tumor lesion).
4.Have measurable disease based on RECIST 1.1 as assessed by investigator and local radiology review.
5.Have provided a newly obtained core or excisional biopsy from a metastatic, not previously irradiated, tumor lesion for central determination of triple-negative breast cancer status and PD-L1 biomarker analysis. Adequacy of the biopsy specimen for the above analyses must be confirmed by the central laboratory. Repeat samples may be required if adequate tumor tissue is not provided.
Note: Subjects for whom fresh tumor biopsies cannot be obtained (e.g. inaccessible tumor site or concern for subject safety) may submit an archived tumor specimen only upon agreement from the Sponsor.
6.Have an ECOG performance status of 0 or 1 assessed within 10 days of treatment initiation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 429
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 171

Exclusion Criteria

1.Has participated in a study of an investigational agent/device and has received/is receiving the investigational agent/device within 4 weeks of randomization.
Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as 4 weeks have elapsed since the last dose of the investigational agent and/or removal of the device.
2.Has had monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks of randomization
3.Has had chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks of randomization
4.Has not recovered (i.e., < or = to Grade 1 or at baseline) from adverse events due to a previously administered therapy.
Note: Subjects with < or = to Grade 2 neuropathy or alopecia of any grade are an exception to this criterion and may qualify for the study.
Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the surgery prior to randomization.
5.Has an 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).
Note: Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
6.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of randomization.
7.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.
8.Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system (CNS) metastases and/or carcinomatous meningitis. Brain imaging at screening is required.
9.Has history of pneumonitis requiring treatment with steroids or history of interstitial lung disease.
10.Has an active infection requiring systemic therapy.
11.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.
12.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
13.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
14.Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) or has previously participated in Merck MK-3475 clinical trials.
15.Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
16.Has a known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Has received a live vaccine within 30 days of randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified