ClinicalTrials.gg
CompletedNCT03284424Updated Aug 23, 2024Results posted

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 interventional study of Pembrolizumab in Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme LLC. Completed at 59 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
159
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 17 studies testing pembrolizumab in Carcinoma, Squamous Cell — 3 open to participants now, 7 under way, none of them phase 3. pembrolizumab · Carcinoma, Squamous Cell.

Enrollment
4th of 17
159 · median 48
Started
2017
with 2 others
Phase 2
13 of 17
3 open now
Registered
7th of 17
by date
Lead sponsor
4 of 17
Merck Sharp & Dohme LLC

Among the 17 studies testing pembrolizumab in Carcinoma, Squamous Cell, this one is the 4th largest by enrollment, is one of 3 that started in 2017, is one of 13 in phase 2, and was the 7th registered.

Carcinoma, Squamous Cell

628 studies on the registry are indexed under Carcinoma, Squamous Cell; 134 are open to participants now.

Browse Carcinoma, Squamous Cell studies →

Open to participants now

3 of the 17 studies testing pembrolizumab in Carcinoma, Squamous Cell are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About pembrolizumab

pembrolizumab: first FDA approval 2014 (KEYTRUDA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 102 Carcinoma, Squamous Cell studies recruiting now, 86 (84%) set no upper age limit and 8 (8%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies testing pembrolizumab in Carcinoma, Squamous Cell, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Squamous Cell Carcinoma

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)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • R/M cSCC cohort only:
  • Has cSCC that is either defined as disseminated disease, and/or unresectable disease that is not curable by surgery or radiation.
  • Has -confirmed cSCC as the primary site of (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.
  • 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 based on 1.1 as assessed by the central imaging vendor.
  • Has an (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 () testing as determined by central laboratory testing prior to study allocation.
  • Has a >3 months.
  • Female participants of must agree to use an adequate method of during the study treatment period and for at least 120 days after the last dose of study treatment.

Exclusion criteria

Exclusion Criteria:

  • 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-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 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) and/or carcinomatous meningitis.
  • Has an active disease that has required systemic treatment in the past 2 years (e.g. with use of disease-modifying agents, anticoagulants, or 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 (HIV) infection.
  • Has a known history of or known active 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    R/M cSCC cohort

    Participants 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.

    Biological: Pembrolizumab

  • Experimental
    LA cSCC cohort

    Participants with LA cSCC receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to approximately 2 years.

    Biological: Pembrolizumab

Interventions

  • BiologicalPembrolizumab

    IV infusion

    Also known as: KEYTRUDA®, MK-3475

06

What researchers measure

Primary outcomes

  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.

    Time frame: Up to approximately 32 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to approximately 56 months

07

Results

Posted Nov 19, 2021

Participant flow

Participant flow — Overall Study
MilestoneRecurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) CohortLocally Advanced Unresectable cSCC Cohort
Started10554
Participants that received a second course of pembrolizumab21
Completed00
Not completed10554
Withdrew: Death7024
Withdrew: Lost to follow-up31
Withdrew: Physician decision12
Withdrew: Withdrawal by subject45
Withdrew: Sponsor's decision2722

Outcome measures

PrimaryObjective 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.

Time frame:
Up to approximately 32 months
Reported as:
Number · Percentage of participants
Objective Response Rate (ORR)
Percentage of participantsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Objective Response Rate (ORR)35.2 (26.2 to 45.2)51.9 (37.8 to 65.7)
SecondaryDuration 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.

Time frame:
Up to approximately 56 months
Reported as:
Median · Months
Duration of Response (DOR)
MonthsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Duration of Response (DOR)1.6 (1.2 to 24.7)2.7 (1.1 to 12.3)
SecondaryDisease 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.

Time frame:
Up to approximately 56 months
Reported as:
Number · Percentage of participants
Disease Control Rate (DCR)
Percentage of participantsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Disease Control Rate (DCR)52.4 (42.4 to 62.2)64.8 (50.6 to 77.3)
SecondaryProgression-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.

Time frame:
Up to approximately 56 months
Reported as:
Median · Months
Progression-free Survival (PFS)
MonthsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Progression-free Survival (PFS)5.7 (3.1 to 8.5)14.4 (5.5 to 43.6)
SecondaryOverall 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.

Time frame:
Up to approximately 56 months
Reported as:
Median · Months
Overall Survival (OS)
MonthsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Overall Survival (OS)23.8 (13.4 to 30.9)NA (33.3 to NA)
SecondaryNumber 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.

Time frame:
Up to approximately 56 months
Reported as:
Count of participants · Participants
Number of Participants Who Experienced One or More Adverse Events (AEs)
ParticipantsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Number of Participants Who Experienced One or More Adverse Events (AEs)10251
SecondaryNumber 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.

Time frame:
Up to approximately 56 months
Reported as:
Count of participants · Participants
Number of Participants Who Discontinued Study Treatment Due to AE
ParticipantsRecurrent or Metastatic Cutaneous cSCC CohortLocally Advanced Unresectable cSCC Cohort
Number of Participants Who Discontinued Study Treatment Due to AE2011

Adverse events

Collected over Up to approximately 56 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course97/159 (61%)87/159 (54.7%)139/159 (87.4%)
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course1/3 (33.3%)2/3 (66.7%)2/3 (66.7%)
Most frequent serious events
Showing 10 of 118
Most frequent serious events
EventRecurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First CourseRecurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course
Cholecystitis acuteHepatobiliary disorders0/1591/3
Scrotal cellulitisInfections and infestations0/1591/3
SepsisInfections and infestations4/1591/3
Weight decreasedInvestigations0/1591/3
Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1591/3
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)9/1590/3
PneumoniaInfections and infestations5/1590/3
AnaemiaBlood and lymphatic system disorders3/1590/3
Infected neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/1590/3
Acute myocardial infarctionCardiac disorders2/1590/3
Most frequent other events
Showing 10 of 43
Most frequent other events
EventRecurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First CourseRecurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course
DiarrhoeaGastrointestinal disorders31/1591/3
AstheniaGeneral disorders35/1591/3
Blood bilirubin increasedInvestigations3/1591/3
Blood phosphorus decreasedInvestigations2/1591/3
Blood urea increasedInvestigations2/1591/3
Protein total decreasedInvestigations1/1591/3
HyperchloraemiaMetabolism and nutrition disorders1/1591/3
HypocalcaemiaMetabolism and nutrition disorders4/1591/3
HyponatraemiaMetabolism and nutrition disorders4/1591/3
Muscle spasmsMusculoskeletal and connective tissue disorders2/1591/3

Baseline characteristics

The analysis population consisted of all participants who received ≥1 dose of study treatment.

Age, Continuous
Age, Continuous(Years)Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) CohortLocally Advanced Unresectable cSCC CohortTotal
Mean70.0 ± 14.373.7 ± 12.471.3 ± 13.8
Sex: Female, Male
Sex: Female, Male(Participants)Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) CohortLocally Advanced Unresectable cSCC CohortTotal
Female251540
Male8039119
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) CohortLocally Advanced Unresectable cSCC CohortTotal
Hispanic or Latino13215
Not Hispanic or Latino574097
Unknown or Not Reported351247
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) CohortLocally Advanced Unresectable cSCC CohortTotal
American Indian or Alaska Native314
Asian000
Native Hawaiian or Other Pacific Islander101
Black or African American011
White6840108
More than one race101
Unknown or Not Reported321244
08

Study locations

59 sites
  • Moores UC San Diego Cancer Center ( Site 0352)
    La Jolla, California 92093-0880, United States
  • Stanford University Medical Center ( Site 0366)
    Palo Alto, California 94305, United States
  • St. Joseph Heritage Healthcare ( Site 0350)
    Santa Rosa, California 95403, United States
  • Yale University ( Site 0365)
    New Haven, Connecticut 06520, United States
  • Lombardi Comprehensive Cancer Center ( Site 0360)
    Washington, District of Columbia 20007, United States
  • Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)
    Indianapolis, Indiana 46202, United States
  • University of Kansas Cancer Center ( Site 0361)
    Westwood, Kansas 66205, United States
  • Massachusetts General Hospital ( Site 0362)
    Boston, Massachusetts 02114, United States
  • Comprehensive Cancer Centers of Nevada ( Site 8001)
    Las Vegas, Nevada 89148, United States
  • John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)
    Hackensack, New Jersey 07601, United States
  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0364)
    Tulsa, Oklahoma 74146, United States
  • Fox Chase Cancer Center ( Site 0351)
    Philadelphia, Pennsylvania 19111, United States
  • Sanford Cancer Center Oncology Clinic ( Site 0356)
    Sioux Falls, South Dakota 57104, United States
  • Texas Oncology PA ( Site 8000)
    Dallas, Texas 75246, United States
  • Orange Health Services ( Site 0406)
    Orange, New South Wales 2800, Australia
  • Southern Medical Day Care Centre ( Site 0408)
    Wollongong, New South Wales 2500, Australia
  • Royal Brisbane and Women s Hospital ( Site 0407)
    Herston, Queensland 4029, Australia
  • Princess Alexandra Hospital ( Site 0405)
    Woolloongabba, Queensland 4102, Australia
  • The Townsville Hospital ( Site 0404)
    Douglas, 4814, Australia
  • Lismore Base Hospital ( Site 0402)
    Lismore, 2480, Australia
  • Dr. Leon Richard Oncology Centre ( Site 0100)
    Moncton, New Brunswick E1C 8X3, Canada
  • The Ottawa Hospital Cancer Centre ( Site 0101)
    Ottawa, Ontario K1H 8L6, Canada
  • Sunnybrook Research Institute ( Site 0105)
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Cancer Centre ( Site 0102)
    Toronto, Ontario M5G 2M9, Canada
  • Jewish General Hospital ( Site 0103)
    Montreal, Quebec H3T 1E2, Canada
  • IUCT - Oncopole ( Site 0604)
    Toulouse, Cedex 9 31059, France
  • Hopital Avicenne ( Site 0609)
    Bobigny, 93009, France
  • CHRU Lille - Hopital Claude Huriez ( Site 0605)
    Lille, 59037, France
  • CHU Limoges CHU Dupuytren ( Site 0608)
    Limoges, 87042, France
  • Hopital La Timone ( Site 0603)
    Marseille, 13005, France
  • Hopital Archet 3 ( Site 0607)
    Nice cedex 3, 06202, France
  • Hopital Saint-Louis ( Site 0601)
    Paris, 75010, France
  • CH Lyon Sud Hospices Civils de Lyon ( Site 0600)
    Pierre Benite, 69310, France
  • CHU Reims - Hopital Robert Debre ( Site 0610)
    Reims, 51092, France
  • Institut Gustave Roussy (IGR) ( Site 0602)
    Villejuif, 94805, France
  • Universitaetsklinikum Essen ( Site 0650)
    Essen, 45147, Germany
  • Medizinische Hochschule Hannover ( Site 0652)
    Hannover, 30625, Germany
  • Universitaets-Hautklinik Kiel ( Site 0656)
    Kiel, 24105, Germany
  • Universitaetsklinikum Mannheim GmbH ( Site 0654)
    Mannheim, 68167, Germany
  • Universitatsklinikum Tübingen ( Site 0651)
    Tuebingen, 72076, Germany
  • Rambam Health Care Campus ( Site 0950)
    Haifa, 3109601, Israel
  • Rabin Medical Center ( Site 0952)
    Petah Tikva, 4963211, Israel
  • Sheba Medical Center ( Site 0953)
    Ramat Gan, 5266202, Israel
  • Sourasky Medical Center. ( Site 0951)
    Tel-Aviv, 6423906, Israel
  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)
    Guadalajara, Jalisco 44200, Mexico
  • Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)
    Monterrey, Nuevo Leon 64000, Mexico
  • Centro Estatal de Cancerologia de Chihuahua ( Site 0308)
    Chihuahua, 31000, Mexico
  • Grupo Medico Camino SC ( Site 0300)
    Mexico City, 03310, Mexico
  • Haukeland Universitetssykehus ( Site 0902)
    Bergen, 5021, Norway
  • Oslo Universitetssykehus Radiumhospitalet ( Site 0901)
    Oslo, 0379, Norway
  • Hospital Duran i Reinals ICO de Hospitalet ( Site 0751)
    Hospitalet del Llobregat, Barcelona 08908, Spain
  • Hospital Vall D Hebron ( Site 0750)
    Barcelona, 08035, Spain
  • Hospital Clinic i Provincial Barcelona ( Site 0754)
    Barcelona, 08036, Spain
  • Hospital Universitario Ramon y Cajal ( Site 0753)
    Madrid, 28034, Spain
  • Hospital General de Valencia ( Site 0752)
    Valencia, 46014, Spain
  • The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)
    Bebington, Wirral CH63 4JY, United Kingdom
  • University College Hospital NHS Foundation Trust ( Site 0801)
    London, NW1 2PG, United Kingdom
  • Royal Marsden NHS Foundation Trust ( Site 0800)
    London, SW3 6JJ, United Kingdom
  • Royal Cornwall Hospitals NHS Trust ( Site 0804)
    Truro, TR1 3LQ, United Kingdom
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References and documents

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 ↗
  • 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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · engagezone.msd.com

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jul 2020, 33 months.

Results were first posted in Nov 2021, 1 year 3 months after primary completion. A results delay was requested in Jul 2021.

Of 98 phase 2 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 82. This study's 33 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2017
First posted
Sep 15, 2017
StartActual
Oct 26, 2017
Primary completionActual
Jul 29, 2020
CompletionActual
Sep 13, 2023
Results delay requested
Jul 14, 2021
Results first posted
Nov 19, 2021
Last update
Aug 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03284424
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Oct 26, 2017
Primary completion
Jul 29, 2020
Completion
Sep 13, 2023
Results posted
Nov 19, 2021
Last update
Aug 23, 2024

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Pembrolizumab

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