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Squamous Cell Carcinoma of the SkinPhase 2NCT04204837

Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin

A Phase 2 study testing Nivolumab and Nivolumab plus Relatlimab in people with Squamous Cell Carcinoma of the Skin, run by Salzburger Landeskliniken at 7 sites in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of the Skin
What is being tested?
Nivolumab and Nivolumab plus Relatlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
7 sitesAustria
Study dates
6 Mar 2017to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, 18 years of age and older on day of signing written informed consent
  • Histologically or cytologically documented locally-advanced and/or metastatic squamous cell carcinoma of the skin (stage III/IV AJCC 2010) that is incurable
  • Archival tumor tissue available for evaluation of PD-L1 and LAG-3 expression
  • Measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
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  • 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
  • Prior radiotherapy must have been completed at least 2 weeks prior to study drug administration
  • Prior systemic antibiotic treatment must have been completed at least 30 days prior to stool sample collection

Who cannot join

  • 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
  • Prior therapy with CTLA-4, PD-1 or LAG-3 antibodies
  • History of myocarditis, regardless of etiology
  • 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
  • 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
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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  • 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.
  • 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
  • Patients with serious intercurrent illness, requiring hospitalization
  • Other serious illnesses, e.g. serious infections requiring antibiotics
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Pregnancy (absence to be confirmed by ß-HCG urinary test, minimum sensitivity 25 IU/L or equivalent units of HCG)) or lactation period
  • Women of childbearing potential (WOCBP): Refusal or inability to use effective means of contraception (Pearl-Index <1)
  • History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
  • 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
  • Known hypersensitivity reaction to any of the components of study treatment

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Martin Laimer, MD contact

+4357255 ext. 58274

m.laimer@salk.at

Roland Lang, PhD contact

+4357255 ext. 58200

r.lang@sak.at

7 sites in 1 country

Austria7 sites, 6 recruiting

  • Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie

    Graz, 8020

    Philipp Jost, MD, philipp.jost@medunigraz.at

    Recruiting

  • LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie

    Innsbruck, 6020

    Van Anh Nguyen, MD, van.nguyen@i-med.ac.at

    Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

    Completed

  • Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg

    Salzburg, 5020

    Martin Laimer, MD, +4357255 ext. 58274, m.laimer@salk.at

    Roland Lang, PhD, +4357255 ext. 58200, r.lang@salk.at

    Recruiting

  • Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften

    Sankt Pölten, 3100

    Christine Hafner, MD, christine.hafner@edu.kl.ac.at

    Recruiting

  • Med Uni Wien, Univ. Klinik für Dermatologie

    Vienna, 1090

    Christoph Höller, MD, christoph.hoeller@meduniwien.ac.at

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

    Matthias Barta, MD, matthias.barta@klinikum-wegr.at

    Recruiting

Other trials in Austria

About this study

Official title: Phase II Study of Nivolumab (Group 1) and Nivolumab Plus Relatlimab (Group 2) in Patients With Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin

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)

Being tested
Nivolumab, Nivolumab plus Relatlimab
Keywords
Nivolumab, Relatlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    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 RelatlimabDrug

    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

Study groups in NCT04204837
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab 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.
Receives: Drug: Nivolumab
Nivolumab plus RelatlimabExperimentalPatients 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
Receives: Drug: Nivolumab plus Relatlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1) per site assessment

    Measured: up to 5 years

Secondary outcomes (7)

  1. Disease Control Rate (DCR)

    Disease Control Rate (DCR) using Response Criteria in Solid Tumors version 1.1 (RECIST1.1) per site assessment

    Measured: up to 5 years

  2. Duration of Response (DOR) in patients who achieve partial response (PR) or better

    Measured: up to 5 years

  3. Progression Free Survival (PFS)

    Measured: up to 5 years

  4. Overall Survival (OS)

    Measured: 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

    Measured: up to 5 years

  6. Number and severity of adverse events

    Measured: 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

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start6 Mar 2017
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204837
Sponsor's protocol ID
CA209-587
Status last verified
Apr 2024
First submitted
17 Dec 2019
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Nivolumab plus Relatlimab in people with Squamous Cell Carcinoma of the Skin, run by Salzburger Landeskliniken at 7 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin Laimer, MD (+4357255 ext. 58274, m.laimer@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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