JOURNAL ONKOLOGIE – STUDIE

Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04204837

Studienbeginn:
März 2017

Letztes Update:
18.04.2024

Wirkstoff:
Nivolumab, Nivolumab plus Relatlimab

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Salzburger Landeskliniken

Collaborator:
Bristol-Myers Squibb

Studienleiter

Martin Laimer, MD
Principal Investigator
Salzburger Landeskliniken

Kontakt

Martin Laimer, MD
Kontakt:
Phone: +4357255
Phone (ext.): 58274
E-Mail: m.laimer@salk.at» Kontaktdaten anzeigen

Roland Lang, PhD
Kontakt:
Phone: +4357255
Phone (ext.): 58200
E-Mail: r.lang@sak.at» Kontaktdaten anzeigen

Studienlocations
(3 von 7)

Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie
8020 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Philipp Jost, MD
E-Mail: philipp.jost@medunigraz.at» Ansprechpartner anzeigen

LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Van Anh Nguyen, MD
E-Mail: van.nguyen@i-med.ac.at» Ansprechpartner anzeigen

Klinikum Klagenfurt am Wörthersee
9020 Klagenfurt
AustriaAbgeschlossen» Google-Maps

Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg
5020 Salzburg
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Martin Laimer, MD
Phone: +4357255
Phone (ext.): 58274
E-Mail: m.laimer@salk.at

Roland Lang, PhD
Phone: +4357255
Phone (ext.): 58200
E-Mail: r.lang@salk.at» Ansprechpartner anzeigen

Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
3100 St.Pölten
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Christine Hafner, MD
E-Mail: christine.hafner@edu.kl.ac.at» Ansprechpartner anzeigen

Med Uni Wien, Univ. Klinik für Dermatologie
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Christoph Höller, MD
E-Mail: christoph.hoeller@meduniwien.ac.at» Ansprechpartner anzeigen

Klinikum Wels-Grieskirchen GmbH
4600 Wels
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Matthias Barta, MD
E-Mail: matthias.barta@klinikum-wegr.at» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

Brief Summary:

To determine the Objective Response Rate (ORR) of immunotherapy with Nivolumab (Group 1) and

Nivolumab plus Relatlimab (Group 2) in patients with locally advanced/metastatic squamous

cell carcinoma of the skin using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1)

per site assessment (Time Frame Group 2: From first dose up to 5 years)

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Men and women, 18 years of age and older on day of signing written informed consent

2. Histologically or cytologically documented locally-advanced and/or metastatic squamous

cell carcinoma of the skin (stage III/IV AJCC 2010) that is incurable

3. Archival tumor tissue available for evaluation of PD-L1 and LAG-3 expression

4. Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

5. Life expectancy of at least 12 weeks

6. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2

7. Screening laboratory values must meet the following criteria and should be obtained

within 14 days prior to registration:

- WBC ≥ 2000/μl

- Neutrophils ≥ 1500/μL

- Platelets ≥ 100 x103/μL

- Hemoglobin > 9.0 g/dL

- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using

the Cockcroft-Gault formula below):

Female CrCl = (140 - age in years) x weight in kg x 0.85/72 x serum creatinine in

mg/dL Male CrCl = (140- age in years) x weight in kg x 1.00/72 x serum creatinine in

mg/dL

- AST/ALT ≤ 3 x ULN

- Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have

total bilirubin < 3.0 mg/dL)

- Negative pregnancy test and effective contraception (Pearl-Index <1) for for

women of childbearing potential (WOCBP) if the risk of conception exists

8. Prior radiotherapy must have been completed at least 2 weeks prior to study drug

administration

9. Prior systemic antibiotic treatment must have been completed at least 30 days prior to

stool sample collection

Exclusion Criteria:

1. Patient is currently participating and receiving study therapy or has participated in

a study of an investigational agent and received study therapy or used an

investigational device within 4 weeks of the first dose of treatment

2. Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies

3. History of myocarditis, regardless of etiology

4. Troponin T (TnT) or I (TnI) > 2× institutional upper limit of normal (ULN).

Participants with TnT or TnI levels between > 1× to 2× ULN will be permitted if repeat

levels within 24 hours are ≤ 1× ULN. If TnT or TnI levels are between > 1× to 2× ULN

within 24 hours, the participant may undergo a cardiac evaluation and be considered

for treatment, based on a favorable benefit/risk assessment by the Investigator. When

repeat levels within 24 hours are not available, a repeat test should be conducted as

soon as possible. If TnT or TnI repeat levels beyond 24 hours are < 2× ULN, the

participant may undergo a cardiac evaluation and be considered for treatment, based on

a favorable benefit/risk assessment by the Investigator

5. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily

prednisone equivalents) or other immunosuppressive medications within 14 days of study

drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg

daily prednisone equivalents are permitted in the absence of active autoimmune disease

6. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

7. Known additional malignancy that is progressing or requires active treatment. Patients

with chronic lymphocytic leukemia that is stable under active therapy are eligible for

inclusion.

8. An active, known or suspected autoimmune disease. Subjects are permitted to enroll if

they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to

autoimmune condition only requiring hormone replacement, psoriasis not requiring

systemic treatment, or conditions not expected to recur in the absence of an external

trigger

9. Patients with serious intercurrent illness, requiring hospitalization

10. Other serious illnesses, e.g. serious infections requiring antibiotics

11. Known psychiatric or substance abuse disorders that would interfere with cooperation

with the requirements of the trial

12. Pregnancy (absence to be confirmed by ß-HCG urinary test, minimum sensitivity 25 IU/L

or equivalent units of HCG)) or lactation period

13. Women of childbearing potential (WOCBP): Refusal or inability to use effective means

of contraception (Pearl-Index <1)

14. History of testing positive for human immunodeficiency virus (HIV) or known acquired

immunodeficiency syndrome (AIDS)

15. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus

ribonucleic acid (HCV antibody) indicating acute or chronic infection

16. History or current evidence of any condition, therapy, or laboratory abnormality that

might confound the results of the study, interfere with the patient's participation

for the full duration of the study, or is not in the best interest of the patient to

participate, in the opinion of the treating Investigator

17. Known hypersensitivity reaction to any of the components of study treatment

Studien-Rationale

Primary outcome:

1. Objective Response Rate (ORR) (Time Frame - up to 5 years):
using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment

Secondary outcome:

1. Disease Control Rate (DCR) (Time Frame - up to 5 years):
Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST1.1) per site assessment

2. Duration of Response (DOR) in patients who achieve partial response (PR) or better (Time Frame - up to 5 years)

3. Progression Free Survival (PFS) (Time Frame - up to 5 years)

4. Overall Survival (OS) (Time Frame - up to 5 years)

5. ORR and DCR for patients with PD-L1-positive tumor expression and/or positive LAG-3 expression of tumor-infiltrating cells (Time Frame - up to 5 years)

6. Number and severity of adverse events (Time Frame - up to 5 years)

7. DOR, PFS and OS for patients with PD-L1-positive tumor expression and/or positive LAG-3 expression of tumor-infiltrating cells (Time Frame - up to 5 years)

Studien-Arme

Experimental: Nivolumab
Nivolumab will be given on Day 1 of every 14-day cycle (Q2W) at a dose of 240 mg as an IV infusion until progression, unacceptable toxicity or discontinuation for other reasons for up to 2 years.
Experimental: Nivolumab plus Relatlimab
Patients wil receive a fixed-dose combination of nivolumab 480 mg and relatlimab 160 mg by intravenous infusion every four weeks (Q4W) (Group 2) for up to two years after initial dosing or until PD - or absence of investigator-assessed clinical benefit

Geprüfte Regime

Nivolumab:
Nivolumab will be given on Day 1 of every 14-day cycle (Q2W) at a dose of 240 mg as an IV infusion until progression, unacceptable toxicity or discontinuation for other reasons for up to 2 years.
Nivolumab plus Relatlimab:
Patients wil receive a fixed-dose combination of nivolumab 480 mg and relatlimab 160 mg by intravenous infusion every four weeks (Q4W) (Group 2) for up to two years after initial dosing or until PD - or absence of investigator-assessed clinical benefit

Quelle: ClinicalTrials.gov

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