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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT03284424

Studienbeginn:
Oktober 2017

Letztes Update:
15.03.2019

Wirkstoff:
Pembrolizumab

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Merck Sharp & Dohme Corp.

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme Corp.

Kontakt

Studienlocations (3 von 59)

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0301)
44200 Guadalajara
MexicoAktiv, nicht rekrutierend» Google-Maps
Hospital y Clinica OCA SA de CV/Monterrey International ResearchCenter ( Site 0306)
64000 Monterrey
MexicoAbgeschlossen» Google-Maps
Centro Estatal de Cancerologia de Chihuahua ( Site 0308)
31000 Chihuahua
MexicoAktiv, nicht rekrutierend» Google-Maps
Grupo Medico Camino SC ( Site 0300)
03310 Mexico City
MexicoAbgeschlossen» Google-Maps
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0803)
CH63 4JY Bebington
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Cornwall Hospitals NHS Trust ( Site 0804)
TR1 3LQ Truro
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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, radiation, or systemic therapy.

- 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 unless the lesion has grown since receiving the 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, radiotherapy, or systemic therapy), and is not amenable to either curative surgery, radiotherapy, or concurrent chemoradiotherapy treatment.

- 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:

- Has cSCC that is amenable to surgical resection, local control with radiotherapy, or local control with a combination of surgery and radiotherapy, or chemoradiotherapy.

- 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.

Studien-Rationale

Primary outcome:

1. Objective Response Rate (ORR) (Time Frame - Up to approximately 24 months):
ORR is 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) as assessed by blinded independent central review (BICR).



Secondary outcome:

1. Duration of Response (DOR) (Time Frame - Up to approximately 24 months):
For participants who demonstrate a CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), DOR is defined as the time from first documented evidence of CR or PR per RECIST 1.1 as assessed by BICR until progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.) per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.

2. Disease Control Rate (DCR) (Time Frame - Up to approximately 24 months):
DCR is defined as the percentage of participants who have CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.]) for at least 12 weeks per RECIST 1.1 as assessed by BICR.

3. Progression-free Survival (PFS) (Time Frame - Up to approximately 24 months):
PFS is defined as the time from first day of study treatment to the first documented PD (At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.] per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.

4. Overall Survival (OS) (Time Frame - Up to approximately 24 months):
OS is defined as the time from first day of study treatment to death due to any cause.

5. Adverse Events (AEs) (Time Frame - Up to approximately 27 months):
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience one or more AEs will be presented.

6. Study Treatment Discontinuations Due to AEs (Time Frame - Up to approximately 24 months):
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

Studien-Arme

  • 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.
  • 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.

Geprüfte Regime

  • Pembrolizumab (MK-3475):
    IV infusion

Quelle: ClinicalTrials.gov


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