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 · Phase 2, Interventional, and Treatment

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

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.

Conditions studied

Squamous Cell Carcinoma

Browse trials for

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)

Who can participate

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

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 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.
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.

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-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.

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

What researchers measure

Primary outcomes

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

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
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
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
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
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
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

Results

Posted Nov 19, 2021

Participant flow

Participant flow — Overall Study
Milestone	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort	Locally Advanced Unresectable cSCC Cohort
Started	105	54
Participants that received a second course of pembrolizumab	2	1
Completed	0	0
Not completed	105	54
Withdrew: Death	70	24
Withdrew: Lost to follow-up	3	1
Withdrew: Physician decision	1	2
Withdrew: Withdrawal by subject	4	5
Withdrew: Sponsor's decision	27	22

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 participants	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally 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)
Months	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally 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 participants	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally 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)
Months	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally 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)
Months	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally 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)
Participants	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally Advanced Unresectable cSCC Cohort
Number of Participants Who Experienced One or More Adverse Events (AEs)	102	51

SecondaryNumber of Participants Who Discontinued Study Treatment Due to AE

Time frame:: Up to approximately 56 months
Reported as:: Count of participants · Participants

Number of Participants Who Discontinued Study Treatment Due to AE
Participants	Recurrent or Metastatic Cutaneous cSCC Cohort	Locally Advanced Unresectable cSCC Cohort
Number of Participants Who Discontinued Study Treatment Due to AE	20	11

Adverse events

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

Adverse event summary by group
Group	Deaths	Serious	Other
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course	97/159 (61%)	87/159 (54.7%)	139/159 (87.4%)
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course	1/3 (33.3%)	2/3 (66.7%)	2/3 (66.7%)

Most frequent serious events

Showing 10 of 118

Most frequent serious events
Event	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course
Cholecystitis acuteHepatobiliary disorders	0/159	1/3
Scrotal cellulitisInfections and infestations	0/159	1/3
SepsisInfections and infestations	4/159	1/3
Weight decreasedInvestigations	0/159	1/3
Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/159	1/3
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	9/159	0/3
PneumoniaInfections and infestations	5/159	0/3
AnaemiaBlood and lymphatic system disorders	3/159	0/3
Infected neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)	3/159	0/3
Acute myocardial infarctionCardiac disorders	2/159	0/3

Most frequent other events

Showing 10 of 43

Most frequent other events
Event	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course	Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course
DiarrhoeaGastrointestinal disorders	31/159	1/3
AstheniaGeneral disorders	35/159	1/3
Blood bilirubin increasedInvestigations	3/159	1/3
Blood phosphorus decreasedInvestigations	2/159	1/3
Blood urea increasedInvestigations	2/159	1/3
Protein total decreasedInvestigations	1/159	1/3
HyperchloraemiaMetabolism and nutrition disorders	1/159	1/3
HypocalcaemiaMetabolism and nutrition disorders	4/159	1/3
HyponatraemiaMetabolism and nutrition disorders	4/159	1/3
Muscle spasmsMusculoskeletal and connective tissue disorders	2/159	1/3

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) Cohort	Locally Advanced Unresectable cSCC Cohort	Total
Mean	70.0 ± 14.3	73.7 ± 12.4	71.3 ± 13.8

Sex: Female, Male
Sex: Female, Male(Participants)	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort	Locally Advanced Unresectable cSCC Cohort	Total
Female	25	15	40
Male	80	39	119

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort	Locally Advanced Unresectable cSCC Cohort	Total
Hispanic or Latino	13	2	15
Not Hispanic or Latino	57	40	97
Unknown or Not Reported	35	12	47

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort	Locally Advanced Unresectable cSCC Cohort	Total
American Indian or Alaska Native	3	1	4
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	0	1	1
White	68	40	108
More than one race	1	0	1
Unknown or Not Reported	32	12	44

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

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

Protocol and statistical analysis plan · Feb 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

Registry details

Key details

Study ID: NCT03284424
Lead sponsor: Merck Sharp & Dohme LLC
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 ↗

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