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A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer, Solid Tumor

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Trial Information

A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors


Inclusion Criteria:



- Histologically or cytologically-confirmed diagnosis of tumor that is recurrent,
metastatic, or persistent:

- For Cohort A - triple negative breast cancer (estrogen, progesterone, and human
epidermal growth factor receptor 2 [HER2] negative)

- For Cohort B - squamous cell carcinoma of the head and neck (including
HPV-positive head and neck squamous cell cancer).

- For Cohort C - urothelial tract cancer of the renal pelvis, ureter, bladder, or
urethra (transitional cell or non-transitional cell histology)

- Any number of prior treatment regimens

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1

- Female participants of childbearing potential must be willing to use 2 methods of
birth control or be surgically sterile, or abstain from heterosexual activity for the
course of the study through 120 days after the last dose of study treatment

- Male participants must agree to use an adequate method of contraception starting with
the first dose of study therapy through 120 days after the last dose of study
treatment

Exclusion Criteria:

- Currently participating in/has participated in a study of an investigational agent or
using an investigational device within 4 weeks of the first dose of study treatment

- Diagnosis of immunosuppression or receiving systemic steroid therapy or any other
form of immunosuppressive therapy within 7 days prior to the first dose of study
treatment

- Monoclonal antibody treatment within 4 weeks prior to study Day 1 or not recovered
from adverse events due to agents administered more than 4 weeks earlier

- Chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks
prior to study Day 1 or not recovered from adverse events due to a previously
administered agent

- Known additional malignancy that is progressing or requires active treatment
excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or
in situ cervical cancer that has undergone potentially curative therapy

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- Active autoimmune disease or documented history of autoimmune disease, or syndrome
that requires systemic steroids or immunosuppressive agents

- Evidence of interstitial lung disease

- Active infection requiring systemic therapy

- Known psychiatric or substance abuse disorders

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment

- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death
1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody

- Known history of human immunodeficiency virus (HIV)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants experiencing adverse events

Outcome Time Frame:

From first dose to 90 days after last dose of study treatment (up to 2 years)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

3475-012

NCT ID:

NCT01848834

Start Date:

May 2013

Completion Date:

January 2015

Related Keywords:

  • Cancer
  • Solid Tumor
  • Neoplasms

Name

Location

Call for Information (Investigational Site 0004)Chicago, Illinois  60637