Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 26, 2017
End Date:June 15, 2022
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475)
in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma
(cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or
radiation and/or systemic therapies.


Inclusion Criteria:

- R/M cSCC cohort only:

- Has cSCC that is either metastatic defined as disseminated disease, and/or
unresectable disease that is not curable by surgery, radiation, or systemic therapy.

- Has histologically-confirmed cSCC as the primary site of malignancy (metastatic skin
involvement from another primary cancer or from an unknown primary cancer is not
permitted).

- LA cSCC cohort only:

- Must be ineligible for surgical resection.

- Participants who received prior radiation therapy (RT) to index site or must be deemed
to be not eligible for RT unless the lesion has grown since receiving the RT.

- Participants who received prior systemic therapy for curative intent are eligible
regardless of regimen.

- R/M cSCC cohort only:

- Has metastatic disease defined as disseminated disease distant to the initial/primary
site of diagnosis, and/or must have locally recurrent disease that has been previously
treated (with either surgery, radiotherapy, or systemic therapy), and is not amenable
to either curative surgery, radiotherapy, or concurrent chemoradiotherapy treatment.

- Has measurable disease based on RECIST 1.1 as assessed by the central imaging vendor.

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within
10 days prior to the start of study treatment.

- Has adequate organ function.

- Has a tissue sample adequate for programmed death-ligand 1 (PD-L1) testing as
determined by central laboratory testing prior to study allocation.

- Has a life expectancy >3 months.

- Female participants of childbearing potential must agree to use an adequate method of
contraception during the study treatment period and for at least 120 days after the
last dose of study treatment.

Exclusion Criteria:

- Has cSCC that is amenable to surgical resection, local control with radiotherapy, or
local control with a combination of surgery and radiotherapy, or chemoradiotherapy.

- Has any other histologic type of skin cancer other than invasive squamous cell
carcinoma as the primary disease under study, e.g. basal cell carcinoma that has not
been definitively treated with surgery or radiation, Bowen's disease, Merkel cell
carcinoma (MCC), melanoma.

- Has had any prior allogeneic solid organ or bone marrow transplantation.

- Has received prior therapy with an anti-programmed death protein-1 (anti-PD-1),
anti-programmed death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent
directed to another stimulatory or co-inhibitory T cell receptor (e.g. cytotoxic
T-lymphocyte associated protein 4 [CTLA-4], Tumor necrosis factor receptor
superfamily, member 4 [OX-40], tumor necrosis factor receptor superfamily member 9
[CD137]).

- Has received prior systemic anti-cancer therapy including investigational agents
within 4 weeks prior to study allocation.

(Notes: Participants must have recovered from all AEs due to previously administered
therapies to ≤ Grade 1 or baseline. If a participant received major surgery, they must have
recovered adequately from the toxicity and/or complications from the intervention prior to
starting study treatment.)

- Has received prior radiotherapy within 2 weeks of start of study treatment.

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study treatment.

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.

- Has an active autoimmune disease that has required systemic treatment in the past 2
years (e.g. with use of disease-modifying agents, anticoagulants, corticosteroids or
immunosuppressive drugs).

- Has a history of (noninfectious) pneumonitis that required steroids or has current
pneumonitis.

- Has an active infection requiring systemic therapy.

- Has a known history of human immunodeficiency virus (HIV) infection.

- Has a known history of Hepatitis B or known active Hepatitis C virus infection.

- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment.
We found this trial at
15
sites
535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Phone: 317-278-4712
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-2694
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Boston, MA
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Dallas, Texas 75246
Phone: 281-863-4697
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Dallas, TX
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Phone: 551-996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Hackensack, NJ
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La Jolla, California 92093
Phone: 858-822-6176
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La Jolla, CA
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Phone: 281-863-4697
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-737-7981
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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Palo Alto, California 94304
Phone: 650-492-9551
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Palo Alto, CA
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Philadelphia, Pennsylvania 19111
Phone: 215-728-3511
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Philadelphia, PA
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Santa Rosa, California 95403
Phone: 707-521-3830
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Santa Rosa, CA
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1309 W 17th Street
Sioux Falls, South Dakota 57104
(605) 328-8000
Phone: 605-328-8000
Sanford Cancer Center-Oncology Clinic Sanford Health is an integrated health system headquartered in the Dakotas...
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Tulsa, Oklahoma 74146
Phone: 918-505-3201
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Washington, District of Columbia 22057
Phone: 202-687-6871
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Westwood, Kansas 66205
Phone: 913-945-7552
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Westwood, KS
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410 Crown Street
Wollongong, New South Wales 2500
Phone: +612 4227 3733
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Wollongong,
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