The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient
with locally advanced or metastatic squamous cell carcinoma of the skin
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02883556
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
- Be willing and able to provide written informed consent/assent for the trial
- Be more than 18 years of age on day of signing informed consent.
- Be either affiliated to, or a beneficiary of, a social security category
- Have metastatic disease, or locally advanced disease not amenable to surgery with
- Be willing and able to undergo pre-treatment baseline biopsy of the tumor
- PD-L1+ or PD-L1- tumors
- Have measurable disease based on RECIST 1.1
- Have a performance status of 0 or 1 on the Easter Cooperative Oncology Group (ECOG)
- Demonstrate adequate organ function as defined in Table 3, all screening labs should
be performed within 10 days of treatment initiation.
- Have recovered from major surgery or radiation therapy
- Female subject of childbearing potential should have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study medication.
- Female subjects of childbearing potential should be willing to use 1 method of birth
control before the first dose of study therapy through 120 days after the last dose of
study therapy. (Reference Section 7.5.1).
Male subjects should 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 therapy.
- Is currently participating and receiving study therapy or has participated in a study
of an investigational agent and received study therapy or used an investigational
device within 4 weeks or 5 half-lives (minimum 14 days), whichever is shorter, prior
to the first dose of treatment.
- Has received prior therapy with either chemotherapy or targeted therapy for the
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has received radiation therapy within 4 weeks prior to study Day 1
- Has 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). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of trial
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., Hepatitis C
Virus RNA [qualitative] is detected).
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy
- Has received a live vaccine within 30 days of planned start of study therapy.
- Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines
and are allowed; however intranasal influenza vaccines (e.g., Fluenz tetra®) are live
attenuated vaccines, and are not allowed.
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has a known additional malignancy. Exceptions include i) basal cell carcinoma of the
skin or other squamous cell carcinoma of the skin or in situ cervical cancer, ii)
history of another non blood malignancy that has undergone potentially curative
therapy without recurrence for more than 2 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with brain metastases may participate provided they are stable
(without evidence of progression by imaging for at least eight weeks prior to the
first dose of trial treatment and any neurologic symptoms have returned to baseline),
have no evidence of new or enlarging brain metastases, and are not using steroids for
at least 7 days prior to trial treatment. This exception does not include
carcinomatous meningitis which is excluded regardless of clinical stability.
- 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.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Is pregnant or 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.
All locations for NCT02883556
Bobigny, France, 93000
View full eligibility
Tris trial is registered with FDA with number: NCT02883556. The sponsor of the trial is Assistance Publique - Hôpitaux de Paris and it is looking for 57 volunteers for the current phase.
Official trial title: Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.