AzTrials
AzTrials

Squamous Cell CarcinomaPhase 2NCT03284424

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)

A Phase 2 study testing Pembrolizumab in people with Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 59 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma
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
159 participants
Where
59 sitesin 10 countries
Study dates
26 Oct 2017to 13 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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 or radiation.
  • 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.
Show all 15Show fewer
  • 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 or radiotherapy), and is not amenable to either curative surgery or radiotherapy.
  • 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.

Who cannot join

  • Has cSCC that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
  • 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.)
Show all 15Show fewer
  • 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.

Trial locations and contacts

59 sites in 10 countries.

59 sites in 10 countries

United States14 sites

  • Massachusetts General Hospital ( Site 0362)

    Boston, Massachusetts, 02114

  • Texas Oncology PA ( Site 8000)

    Dallas, Texas, 75246

  • John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)

    Hackensack, New Jersey, 07601

  • Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)

    Indianapolis, Indiana, 46202

  • Moores UC San Diego Cancer Center ( Site 0352)

    La Jolla, California, 92093-0880

  • Comprehensive Cancer Centers of Nevada ( Site 8001)

    Las Vegas, Nevada, 89148

  • Yale University ( Site 0365)

    New Haven, Connecticut, 06520

  • Stanford University Medical Center ( Site 0366)

    Palo Alto, California, 94305

  • Fox Chase Cancer Center ( Site 0351)

    Philadelphia, Pennsylvania, 19111

  • St. Joseph Heritage Healthcare ( Site 0350)

    Santa Rosa, California, 95403

  • Sanford Cancer Center Oncology Clinic ( Site 0356)

    Sioux Falls, South Dakota, 57104

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0364)

    Tulsa, Oklahoma, 74146

  • Lombardi Comprehensive Cancer Center ( Site 0360)

    Washington D.C., District of Columbia, 20007

  • University of Kansas Cancer Center ( Site 0361)

    Westwood, Kansas, 66205

Other trials in United States

France10 sites

  • Hopital Avicenne ( Site 0609)

    Bobigny, 93009

  • CHRU Lille - Hopital Claude Huriez ( Site 0605)

    Lille, 59037

  • CHU Limoges CHU Dupuytren ( Site 0608)

    Limoges, 87042

  • Hopital La Timone ( Site 0603)

    Marseille, 13005

  • Hopital Archet 3 ( Site 0607)

    Nice, 06202

  • Hopital Saint-Louis ( Site 0601)

    Paris, 75010

  • CH Lyon Sud Hospices Civils de Lyon ( Site 0600)

    Pierre-Bénite, 69310

  • CHU Reims - Hopital Robert Debre ( Site 0610)

    Reims, 51092

  • IUCT - Oncopole ( Site 0604)

    Toulouse, Cedex 9, 31059

  • Institut Gustave Roussy (IGR) ( Site 0602)

    Villejuif, 94805

Other trials in France

Australia6 sites

  • The Townsville Hospital ( Site 0404)

    Douglas, 4814

  • Royal Brisbane and Women s Hospital ( Site 0407)

    Herston, Queensland, 4029

  • Lismore Base Hospital ( Site 0402)

    Lismore, 2480

  • Orange Health Services ( Site 0406)

    Orange, New South Wales, 2800

  • Southern Medical Day Care Centre ( Site 0408)

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital ( Site 0405)

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada5 sites

  • Dr. Leon Richard Oncology Centre ( Site 0100)

    Moncton, New Brunswick, E1C 8X3

  • Jewish General Hospital ( Site 0103)

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital Cancer Centre ( Site 0101)

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Research Institute ( Site 0105)

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre ( Site 0102)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany5 sites

  • Universitaetsklinikum Essen ( Site 0650)

    Essen, 45147

  • Medizinische Hochschule Hannover ( Site 0652)

    Hanover, 30625

  • Universitaets-Hautklinik Kiel ( Site 0656)

    Kiel, 24105

  • Universitaetsklinikum Mannheim GmbH ( Site 0654)

    Mannheim, 68167

  • Universitatsklinikum Tübingen ( Site 0651)

    Tübingen, 72076

Other trials in Germany

Spain5 sites

  • Hospital Vall D Hebron ( Site 0750)

    Barcelona, 08035

  • Hospital Clinic i Provincial Barcelona ( Site 0754)

    Barcelona, 08036

  • Hospital Duran i Reinals ICO de Hospitalet ( Site 0751)

    Hospitalet Del Llobregat, Barcelona, 08908

  • Hospital Universitario Ramon y Cajal ( Site 0753)

    Madrid, 28034

  • Hospital General de Valencia ( Site 0752)

    Valencia, 46014

Other trials in Spain

Israel4 sites

  • Rambam Health Care Campus ( Site 0950)

    Haifa, 3109601

  • Rabin Medical Center ( Site 0952)

    Petah Tikva, 4963211

  • Sheba Medical Center ( Site 0953)

    Ramat Gan, 5266202

  • Sourasky Medical Center. ( Site 0951)

    Tel Aviv, 6423906

Other trials in Israel

Mexico4 sites

  • Centro Estatal de Cancerologia de Chihuahua ( Site 0308)

    Chihuahua City, 31000

  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)

    Guadalajara, Jalisco, 44200

  • Grupo Medico Camino SC ( Site 0300)

    Mexico City, 03310

  • Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)

    Monterrey, Nuevo León, 64000

Other trials in Mexico

United Kingdom4 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)

    Bebington, Wirral, CH63 4JY

  • University College Hospital NHS Foundation Trust ( Site 0801)

    London, NW1 2PG

  • Royal Marsden NHS Foundation Trust ( Site 0800)

    London, SW3 6JJ

  • Royal Cornwall Hospitals NHS Trust ( Site 0804)

    Truro, TR1 3LQ

Other trials in United Kingdom

Norway2 sites

  • Haukeland Universitetssykehus ( Site 0902)

    Bergen, 5021

  • Oslo Universitetssykehus Radiumhospitalet ( Site 0901)

    Oslo, 0379

Other trials in Norway

About this study

Official title: 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.

Being tested
Pembrolizumab
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
Carcinoma, Squamous Cell, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    IV infusion

Study groups in NCT03284424
Study groupRoleWhat they receive
R/M cSCC cohortExperimentalParticipants with R/M cSCC receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Receives: Biological: Pembrolizumab
LA cSCC cohortExperimentalParticipants with LA cSCC receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to approximately 2 years.
Receives: Biological: Pembrolizumab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented.

    Measured: Up to approximately 32 months

Secondary outcomes (6)

  1. Duration of Response (DOR)

    For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 as assessed by BICR is presented for all participants who experienced a confirmed CR or PR.

    Measured: Up to approximately 56 months

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease). The DCR per RECIST 1.1 as assessed by BICR is presented.

    Measured: Up to approximately 56 months

  3. Progression-free Survival (PFS)

    PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause, whichever occurred first. PFS per RECIST 1.1 as assessed by BICR is presented.

    Measured: Up to approximately 56 months

  4. Overall Survival (OS)

    OS was defined as the time from first dose of study treatment to death due to any cause. The OS for all participants is presented.

    Measured: Up to approximately 56 months

  5. Number of Participants Who Experienced One or More Adverse Events (AEs)

    An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who experienced an AE is presented.

    Measured: Up to approximately 56 months

  6. Number of Participants Who Discontinued Study Treatment Due to AE

    An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who discontinued study treatment due to an AE is presented.

    Measured: Up to approximately 56 months

Timeline

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

  1. First posted15 Sep 2017
  2. Study start26 Oct 2017
  3. Primary completion29 Jul 2020
  4. Study completion13 Sep 2023

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03284424
Sponsor's protocol ID
3475-629
Other IDs
MK-3475-629, KEYNOTE-629, 2017-000594-37, 2017
Status last verified
Jul 2024
First submitted
14 Sep 2017
Last updated
23 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Grob JJ, Gonzalez R, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Zhang P, Gumuscu B, Swaby RF, Hughes BGM. Pembrolizumab Monotherapy for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: A Single-Arm Phase II Trial (KEYNOTE-629). J Clin Oncol. 2020 Sep 1;38(25):2916-2925. doi: 10.1200/JCO.19.03054. Epub 2020 Jul 16.

    PubMed 32673170

  • Bratland A, Munoz-Couselo E, Mortier L, Roshdy O, Gonzalez R, Schachter J, Arance AM, Grange F, Meyer N, Joshi AJ, Billan S, Hughes BGM, Grob JJ, Ramakrishnan K, Ge J, Gumuscu B, Swaby RF, Gutzmer R. Health-Related Quality of Life with Pembrolizumab in Patients with Locally Advanced or Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma: KEYNOTE-629. Dermatol Ther (Heidelb). 2023 Dec;13(12):3165-3180. doi: 10.1007/s13555-023-01059-y. Epub 2023 Nov 9.

    PubMed 37943491

  • Hughes BGM, Mendoza RG, Basset-Seguin N, Vornicova O, Schachter J, Joshi A, Meyer N, Grange F, Piulats JM, Bauman JR, Chirovsky D, Zhang P, Gumuscu B, Swaby RF, Grob JJ. Health-Related Quality of Life of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma Treated with Pembrolizumab in KEYNOTE-629. Dermatol Ther (Heidelb). 2021 Oct;11(5):1777-1790. doi: 10.1007/s13555-021-00598-6. Epub 2021 Sep 23.

    PubMed 34558040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 59 sites in 10 countries.

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 15 inclusion and 15 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, France, Australia, Canada, Germany and 5 more countries. 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?

Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: Up to approximately 32 months). 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 NCT03284424, which also lists 3 linked publications.

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 23 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in