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JOURNAL ONKOLOGIE – STUDIE

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT03969004

Studienbeginn:
Juni 2019

Letztes Update:
21.04.2021

Wirkstoff:
Cemiplimab, Placebo

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Regeneron Pharmaceuticals

Collaborator:
Sanofi

Studienleiter

Clinical Trial Management
Study Director
Regeneron Pharmaceuticals

Kontakt

Studienlocations
(3 von 120)

Regeneron Research Site
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
55131 Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
21614 Buxtehude
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
74078 Heilbronn
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
80337 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Regeneron Research Site
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Regeneron Research Facility
85234 Gilbert
United StatesRekrutierend» Google-Maps
Regeneron Research Site
85724-5024 Tucson
United StatesRekrutierend» Google-Maps
Regeneron Research Site
90025 Los Angeles
United StatesRekrutierend» Google-Maps
Regeneron Research Site
94143-0981 San Francisco
United StatesRekrutierend» Google-Maps
Regeneron Research Site
20037 Washington
United StatesRekrutierend» Google-Maps
Regeneron Research Site
30342 Atlanta
United StatesRekrutierend» Google-Maps
Regeneron Research Site
60611 Chicago
United StatesRekrutierend» Google-Maps
Regeneron Research Site
40202 Louisville
United StatesRekrutierend» Google-Maps
Regeneron Research Site
21287 Baltimore
United StatesRekrutierend» Google-Maps
Regeneron Research Site
02114 Boston
United StatesRekrutierend» Google-Maps
Regeneron Research Site
02215 Boston
United StatesRekrutierend» Google-Maps
Regeneron Research Site
65212 Columbia
United StatesRekrutierend» Google-Maps
Regeneron Research Site
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Regeneron Research Site
10016 New York
United StatesRekrutierend» Google-Maps
Regeneron Research Site
10032 New York
United StatesRekrutierend» Google-Maps
Regeneron Research Site
10065 New York
United StatesRekrutierend» Google-Maps
Regeneron Research Site
45267 Cincinnati
United StatesRekrutierend» Google-Maps
Regeneron Research Site
43230 Gahanna
United StatesRekrutierend» Google-Maps
Regeneron Research Site
17025 Hershey
United StatesRekrutierend» Google-Maps
Regeneron Research Site
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Regeneron Research Site
37203 Nashville
United StatesRekrutierend» Google-Maps
Regeneron Research Site
75246 Dallas
United StatesRekrutierend» Google-Maps
Regeneron Research Facility
75390 Dallas
United StatesRekrutierend» Google-Maps
Regeneron Research Site
22908 Charlottesville
United StatesRekrutierend» Google-Maps
Regeneron Research Site
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Regeneron Research Sites
2650 Wagga Wagga
AustraliaRekrutierend» Google-Maps
Regeneron Research Facility
2298 Waratah
AustraliaRekrutierend» Google-Maps
Regeneron Research Facility
4029 Herston
AustraliaRekrutierend» Google-Maps
Regeneron Research Site
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Regeneron Research Site
5037 Kurralta Park
AustraliaRekrutierend» Google-Maps
Regeneron Research Site
99010-080 Passo Fundo
BrazilRekrutierend» Google-Maps
Regeneron Research Site
88020-210 Florianopolis
BrazilRekrutierend» Google-Maps
Regeneron Research Site
05403-000 Sao Paulo
BrazilRekrutierend» Google-Maps
Regeneron Research Site
92100 Boulogne Billancourt
FranceRekrutierend» Google-Maps
Regeneron Research Site
75475 Paris Cedex 10
FranceRekrutierend» Google-Maps
Regeneron Research Site
69495 Pierre Benite Cedex
FranceRekrutierend» Google-Maps
Regeneron Research Site
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
Regeneron Research Site
411-8777 Nagaizumi-Cho
JapanRekrutierend» Google-Maps
Regeneron Research Site
4410 Palmerston North
New ZealandRekrutierend» Google-Maps
Regeneron Research Site
354057 Sochi
Russian FederationRekrutierend» Google-Maps
Regeneron Research Site
357502 Pyatigorsk
Russian FederationRekrutierend» Google-Maps
Regeneron Research Site
455001 Magnitogorsk
Russian FederationRekrutierend» Google-Maps
Regeneron Research Site
644013 Omsk
Russian FederationRekrutierend» Google-Maps
Regeneron Research Site
344037 Rostov-Na-Donu
Russian FederationRekrutierend» Google-Maps
Regeneron Research Site
198255 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Regeneron Research Facility
28850 Torrejon de Ardoz
SpainRekrutierend» Google-Maps
Regeneron Research Site
EH4 2XU Edinburgh
United KingdomRekrutierend» Google-Maps
Regeneron Research Site
BS2 8ED Bristol
United KingdomRekrutierend» Google-Maps
Regeneron Research Site
M20 4QL Manchester
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The primary objective of the study is to compare disease-free survival (DFS) of patients with

high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus

those treated with placebo, after surgery and radiation therapy (RT).

The secondary objectives of the study are:

- To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant

cemiplimab, versus those treated with placebo, after surgery and RT

- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom

from locoregional recurrence (FFLRR) after surgery and RT

- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom

from distant recurrence (FFDR) after surgery and RT

- To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative

incidence of second primary CSCC tumors (SPTs) after surgery and RT

- To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC

patients after surgery and RT

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- For Japan only, men and women ≥21 years old

- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or

primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC

lesion previously treated within the draining lymph node echelon), with macroscopic

gross resection of all disease

- High risk CSCC, as defined in the protocol

- Completion of curative intent post-operative radiation therapy (RT) within 2 to 6

weeks of randomization

- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1

- Adequate hepatic, renal, and bone marrow function as defined in the protocol

Key Exclusion Criteria:

- Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the

protocol

- Concurrent malignancy other than localized CSCC and/or history of malignancy other

than localized CSCC within 3 years of date of randomization as defined in the protocol

- Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))

- Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless

the disease-free interval is at least 3 years (regional nodal involvement of disease

in draining lymph node basin that was resected and radiated prior to enrollment will

not be exclusionary)

- Ongoing or recent (within 5 years of randomization date) evidence of significant

autoimmune disease that required treatment with systemic immunosuppressive treatments,

which may suggest risk for immune-related adverse events (irAEs). The following are

not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes,

residual hypothyroidism that required only hormone replacement, or psoriasis that does

not require systemic treatment.

- Has had prior systemic anti-cancer immunotherapy for CSCC

Note: Other protocol defined Inclusion/Exclusion criteria apply

Studien-Rationale

Primary outcome:

1. DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. (Time Frame - Up to 54 months):
For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.



Secondary outcome:

1. Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive. (Time Frame - Up to 78 months)

2. FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death. (Time Frame - Up to 54 months):
For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.

3. Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death. (Time Frame - Up to 54 months):
For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.

4. Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study. (Time Frame - Up to 54 months)

5. Incidence and severity of treatment-emergent adverse events (TEAE) (Time Frame - Up to 78 months)

6. Incidence of deaths (Time Frame - Up to 78 months)

7. Incidence of laboratory abnormalities (Time Frame - Up to 78 months)

Studien-Arme

  • Experimental: Cemiplimab
  • Placebo Comparator: Placebo

Geprüfte Regime

  • Cemiplimab (REGN2810 / Libtayo / ):
    Intravenous (IV) infusion over 30 minutes
  • Placebo:
    Intravenous (IV) infusion over 30 minutes

Quelle: ClinicalTrials.gov


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