Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
avril 2019
décembre 2025
23 juillet 2025
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with
placebo given as adjuvant therapy in participants with high-risk locally advanced
cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative
intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is
superior to placebo in increasing recurrence free survival (RFS).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 25/05/2024 16:44:45 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| C.H.U. de Nimes. Hopital Caremeau ( Site 0368) - 30029 - Nimes - Gard - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Annecy Genevois ( Site 0361) - 74374 - Pringy - Haute-Savoie - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Valence ( Site 0377) - 26953 - Valence - Drome - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365) - 14000 - Caen - Calvados - France | Contact (sur clinicalTrials) | ||||
| CH Lyon Sud Hospices Civils de Lyon ( Site 0350) - 69495 - Pierre Benite - Rhone - France | Contact (sur clinicalTrials) | ||||
| CHRU de Lille - Hopital Claude Huriez ( Site 0355) - 59037 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| CHU Besancon - Hopital Jean Minjoz ( Site 0359) - 25030 - Besancon - Doubs - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux- Hopital Saint Andre ( Site 0370) - 33075 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| CHU Estaing ( Site 0360) - 63003 - Clermont-Ferrand - Puy-de-Dome - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier. ( Site 0367) - 34295 - Montpellier - Herault - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers ( Site 0375) - 86021 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| Hopital ARCHET 2 ( Site 0356) - 06200 - Nice - Alpes-Maritimes - France | Contact (sur clinicalTrials) | ||||
| Hopital La Timone ( Site 0353) - 13385 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Joseph ( Site 0376) - 13285 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud IUCT Oncopole ( Site 0354) - 31059 - Toulouse - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
- Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary
site of malignancy (metastatic skin involvement from another type of primary cancer
or from an unknown primary cancer is not permitted)
- Has histologically confirmed locally advanced cutaneous squamous cell carcinoma (LA
cSCC) with ≥1 high-risk feature(s) as the primary site of malignancy
- Has undergone complete macroscopic resection of all known cSCC disease with or
without microscopic positive margins. For those participants with residual
microscopic positive margin involvement, confirmation that additional re-excision is
not possible must be provided
- Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks
and ≤16 weeks from randomization
- Has received an adequate post-op dose of RT (either hypofractionated or
conventional)
- Is disease free as assessed by the investigator with complete radiographic staging
assessment ≤28 days from randomization
- Is not pregnant or breastfeeding
- Is not a person of childbearing potential (POCBP)
- Has a negative pregnancy test ≤72 hours before the first dose of study intervention.
- Has provided an archival or newly-obtained tumor tissue sample adequate for
Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory
testing
- Has a life expectancy of >3 months
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10
days prior to the first dose of study intervention.
Inclusion Criteria include, but are not limited to:
- Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary
site of malignancy (metastatic skin involvement from another type of primary cancer
or from an unknown primary cancer is not permitted)
- Has histologically confirmed locally advanced cutaneous squamous cell carcinoma (LA
cSCC) with ≥1 high-risk feature(s) as the primary site of malignancy
- Has undergone complete macroscopic resection of all known cSCC disease with or
without microscopic positive margins. For those participants with residual
microscopic positive margin involvement, confirmation that additional re-excision is
not possible must be provided
- Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks
and ≤16 weeks from randomization
- Has received an adequate post-op dose of RT (either hypofractionated or
conventional)
- Is disease free as assessed by the investigator with complete radiographic staging
assessment ≤28 days from randomization
- Is not pregnant or breastfeeding
- Is not a person of childbearing potential (POCBP)
- Has a negative pregnancy test ≤72 hours before the first dose of study intervention.
- Has provided an archival or newly-obtained tumor tissue sample adequate for
Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory
testing
- Has a life expectancy of >3 months
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10
days prior to the first dose of study intervention.
Exclusion criteria include, but are not limited to:
- Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC
disease before randomization
- Has any other histologic type of skin cancer other than invasive cSCC (eg, basal
cell carcinoma) that has not been definitively treated with surgery or radiation;
Bowen's disease; Merkel cell carcinoma; or melanoma
- Has received prior therapy with an anti-programmed cell death receptor 1(PD-1),
anti-PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an
agent directed to another costimulatory or coinhibitory T-cell receptor (eg,
cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
- Has received prior systemic anticancer therapy including investigational agents for
cSCC ≤4 weeks prior to before start of study intervention.
- Has not recovered from all radiation-related toxicities and has not had radiation
pneumonitis
- Has received a live vaccine ≤30 days prior to the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4
weeks prior to the first dose of study treatment.
- Has known additional malignancy that is progressing or has required active treatment
within the past 2 years. Note: Participants with basal cell carcinoma of the skin,
squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in
situ of the bladder, that have undergone potentially curative therapy are not
excluded. Other exceptions may be considered with Sponsor consultation. Note:
Participants with low risk early-stage prostate cancer defined as below are not
excluded: Stage T1c or T2a with a Gleason score ≤6 and a prostate-specific antigen
(≤10 ng/ml) either treated with definitive intent or untreated in active
surveillance that has been stable for the past year prior to study allocation. Early
stage asymptomatic CLL without prior treatment and without any of the risk features
(unmutated IGHV, lymphocytes >15,000μL, palpable lymph nodes) will be eligible for
the study
- Has an active autoimmune disease that has required systemic treatment in past 2
years except replacement therapy (eg, thyroxine, insulin, or physiologic
corticosteroid).
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative]
is detected) 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 intervention
- Has had an allogeneic tissue/solid organ transplant