Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive pembrolizumab
by vein over about 30 minutes on Day 1 (+/- 3 days) of each 21-day cycle.
On Day 1 of each cycle:
- You will have a physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests.
At Cycles 3, every 3rd cycle after that (Cycles 6, 9, 12, and so on), and if the disease
gets worse, blood (about 10 tablespoons) will be drawn for biomarker and immune system
About every 2 Cycles, you will have imaging scans to check the status of the disease as part
of standard of care.
Length of Study:
You may continue taking the study drug for up to 24 months, as long as the doctor thinks it
is in your best interest. You will no longer be able to take the study drug if the disease
gets worse, if intolerable side effects occur, or if you are unable to follow study
Your participation on the study will be over after the follow-up visits.
After you stop receiving the study drug:
- You will have a physical exam.
- Blood (about 10 tablespoons) will be drawn for routine tests.
- You will have the same imaging scans you had at screening to check the status of the
About 1 and 3 months after the last dose of study drug, you will be asked about your health
and any side effects you may have had. You may be asked during a routine clinic visit or
you may be called. If you are called, each call should last about 2 minutes.
This is an investigational study. Pembrolizumab is FDA approved and commercially available
for the treatment of metastatic melanoma. Its use in patients with metastatic IBC is
investigational. The study doctor can describe how the study drug is designed to work.
Up to 35 participants will be enrolled in this study. All will take part in at MD Anderson.
1. Is willing and able to provide written informed consent for the trial.
2. Is a female or male and >/= 18 years of age
3. Has histological confirmation of breast carcinoma with a clinical diagnosis of IBC
based on presence of inflammatory changes in the involved breast, including diffuse
erythema and edema (peau d'orange), with or without an underlying palpable mass
involving the majority of the skin of the breast. Pathological evidence of dermal
lymphatic invasion should be noted but is not required for diagnosis of inflammatory
4. Has stage IV or recurrent disease after treated primary IBC.
5. Has clinical response after receiving the first line or second line chemotherapy for
metastatic disease. A minimum of two cycles (6-8 weeks) of chemotherapy is required
to determine clinical response. The response should be confirmed by repeat
assessments that should be performed no less than 4 weeks after the criteria for
response are first met. Per RECIST criteria 1.1, Clinical response for measurable
disease is defined as complete response (CR) or partial response (PR); for
non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and
pathological lymph nodes >/= 10 to <15 mm short axis) is defined as persistence of
one or more non-target lesion(s) and no increase in overall tumor burden.
6. Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or
HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not
7. Has a performance status of 0-1 on the ECOG Performance Scale.
8. Has adequate organ function as determined by the following laboratory values: ANC >/=
1,500 /mcL, Platelets >/=100,000 /mcL, Hgb >/= 9 g/dL, creatinine levels < 1.5 x ULN,
Total bilirubin </= 1.5 x ULN, ALT and AST </= 2.5 x ULN or </=5 x ULN for subjects
with liver metastases.
9. Subjects of childbearing potential should be willing to use effective methods of
birth control or be surgically sterile, or abstain from heterosexual activity for the
course of the study through at least 4 months after the last dose of study
drug.Subjects of childbearing potential are those who have not been surgically
sterilized or have not been free from menses for > 1 year. Effective methods of birth
control include 1). Use of hormonal birth control methods: pills, shots/injections,
implants (placed under the skin by a health care provider), or patches (placed on the
skin); 2).Intrauterine devices (IUDs); 3).Using 2 barrier methods (each partner must
use 1 barrier method) with a spermicide. Males must use the male condom (latex or
other synthetic material) with spermicide. Females must choose either a Diaphragm
with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already
in the contraceptive sponge).
10. Has negative serum or urine pregnancy test for subjects of childbearing potential.
1. Is currently participating in a study of an investigational anti-cancer agent.
2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy.
3. Has not recovered from adverse events due to prior therapies, i.e. monoclonal
antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or
surgery.( Note: Subjects with Grade 2 neuropathy, alopecia and general disorders
and administration site conditions (per CTCAE version 4.0) are an exception to this
criterion and may qualify for the study.)
4. Has a known malignancy (other than breast cancer) except basal cell carcinoma or
squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone
potentially curative therapy.
5. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases may participate if they
are stable, and have no evidence of new or enlarging brain metastases, and are not
using steroids for at least 7 days prior to trial treatment.
6. Has an active autoimmune disease requiring systemic treatment within the past 3
months or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo
or resolved childhood asthma/atopy would be an exception to this rule. Subjects that
require intermittent use of bronchodilators or local steroid injections would not be
excluded from the study. Subjects with hypothyroidism stable on hormone replacement
or Sjorgen's syndrome will not be excluded from the study.
7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
8. Has an active infection requiring systemic therapy.
9. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
10. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including
ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways).
11. Has a known history of Human Immunodeficiency Virus (HIV).
12. Has a known active Hepatitis B or Hepatitis C
13. Have received a live vaccine within 30 days prior to the first dose of trial
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both