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Carcinoma, Squamous CellPhase 2CARSKINNCT02883556

Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

A Phase 2 study testing Pembrolizumab in people with Carcinoma, Squamous Cell, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Squamous Cell
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteFrance
Study dates
27 Mar 2017to 15 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 documented progression
  • Be willing and able to undergo pre-treatment baseline biopsy of the tumor
  • PD-L1+ or PD-L1- tumors
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  • Have measurable disease based on RECIST 1.1
  • Have a performance status of 0 or 1 on the Easter Cooperative Oncology Group (ECOG) Performance Scale.
  • 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.

Who cannot join

  • 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 present tumor
  • 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 treatment.
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Avicenne

    Bobigny, 93000

Other trials in France

About this study

Official title: Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

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

Read the detailed description

Agents blocking the Programmed Cell Death 1(PD1)/Programmed Cell Death 1-Ligand 1 (PD-L1) pathway have demonstrated objective, durable tumor regressions in patients with advanced solid malignancies and efficacy has been linked to PD-L1 expression. PD-L1 expression by tumour cells is the strongest single predictor of response to anti-PD1 therapy (J Taube, R Anders et al, Clin Cancer Res 2014). Pembrolizumab (MK-3475) is a high-affinity humanized monoclonal anti-PD1 antibody. It leads to dual PD1-ligand blockade of PD-L1 and PD-L2 that may reactivate the immune surveillance and elicit anti-tumour response. It has antitumor activity in melanoma and NSCLC (phase III trials). Pembrolizumab might be of interest in unresectable squamous cell carcinomas of the skin (SCCS).

Approximately 20% to 30% of non-melanoma skin cancers are SCCS. Most patients with primary SCCS have an excellent prognosis, but SCCS can progress to advanced stages that are impossible to treat by surgical excision or radiotherapy. Few therapeutic options are available for these tumors. Conventional chemotherapy, such as cisplatin-based combinations, has some efficacy, but the toxic effects of these combinations often prohibit their use in elderly patients. Epidermal Growth Factor (EGFR) signaling antagonists have activity only in a subset of patients. New therapeutic options are needed for patients with advanced SCCS.

No trial evaluating pembrolizumab in human SCCS is ongoing. Investigators hypothesize that:

  1. PD-L1 is expressed in SCCS as in HNSCC ii) pembrolizumab may be effective as a single agent in patients with unresectable SCCS iii) Efficacy of pembrolizumab is correlated to PD-L1 expression in SCCS.

Investigators therefore intend to determine the efficacy and safety of single agent pembrolizumab in all patients and in patients with PD-L1-positive unresectable SCCS naïve of chemotherapy and of EGFR inhibitors.

Being tested
Pembrolizumab
Keywords
Carcinoma, Squamous Cell, Skin, pembrolizumab, Programmed Cell Death 1 Ligand 1
Medical subject headings
Carcinoma, Squamous Cell, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called MK-3475, KEYTRUDA

    200 mg, administered as intravenous (IV) infusion every 3 weeks up to 24 months or until progression or unacceptable toxicity develops.

Study groups in NCT02883556
Study groupRoleWhat they receive
Pembrolizumab 200 mgExperimentalPembrolizumab 200 mg administered as intravenous (IV) infusion every 3 weeks up to 24 months or until progression or unacceptable toxicity develops.
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (RR)

    Response rate (RR) at 15 weeks (RECIST v.1.1) in the whole sample by CT or MRI Response Evaluation Criteria in Solid Tumors with central radiology review

    Measured: 15 weeks

Secondary outcomes (11)

  1. Safety profile (NCI CTCAE v4.0)

    Advers event and serious adverse event status

    Measured: up to 28 months

  2. RR in PD-L1-positive patients

    To assess in the whole sample and in PD-L1 positive patients

    Measured: 15 weeks

  3. Disease Control Rate using RECIST and modified RECIST v.1.1

    Controled by the radiological evaluation

    Measured: 15 weeks

  4. RR using modified RECIST 1.1

    Controled by the radiological evaluation

    Measured: 15 weeks

  5. RR using RECIST and modified RECIST v.1.1

    Controled by the radiological evaluation

    Measured: 24 weeks

  6. Best RR using RECIST and modified RECIST v.1.1

    The best response was collected after all radiological evaluation completion

    Measured: 24 months

  7. Overall Survival (OS)

    Survival status

    Measured: up to 24 months

  8. Progression Free Survival by RECIST 1.1 and modified RECIST 1.1

    Controled by the radiological evaluation

    Measured: up to 24 months

  9. Duration of response (DOR) by RECIST 1.1 and modified RECIST 1.1

    Controled by the radiological evaluation

    Measured: up to 24 months

  10. Duration of control by RECIST 1.1 and modified RECIST 1.1

    Controled by the radiological evaluation

    Measured: up to 24 months

  11. Time to disease progression by RECIST 1.1 and modified RECIST 1.1

    Controled by the radiological evaluation

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study start27 Mar 2017
  3. Primary completion23 Mar 2019
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02883556
Sponsor's protocol ID
P151202
Other IDs
2016-002076-28, 2016
Acronym
CARSKIN
Status last verified
Jul 2020
First submitted
25 Aug 2016
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maubec E, Boubaya M, Petrow P, Beylot-Barry M, Basset-Seguin N, Deschamps L, Grob JJ, Dreno B, Scheer-Senyarich I, Bloch-Queyrat C, Leccia MT, Stefan A, Saiag P, Grange F, Meyer N, de Quatrebarbes J, Dinulescu M, Legoupil D, Machet L, Dereure O, Zehou O, Montaudie H, Wierzbicka-Hainaut E, Le Corre Y, Mansard S, Guegan S, Arnault JP, Dalac S, Aubin F, Alloux C, Lopez I, Cherbal S, Tibi A, Levy V; Groupe de Cancerologie Cutanee30. Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas. J Clin Oncol. 2020 Sep 10;38(26):3051-3061. doi: 10.1200/JCO.19.03357. Epub 2020 Jul 30.

    PubMed 32730186

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Carcinoma, Squamous Cell, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (RR) (time frame: 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02883556, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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