- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04204837
Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin
April 17, 2024 updated by: Martin Laimer, MD, MSc, Salzburger Landeskliniken
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martin Laimer, MD
- Phone Number: 58274 +4357255
- Email: m.laimer@salk.at
Study Contact Backup
- Name: Roland Lang, PhD
- Phone Number: 58200 +4357255
- Email: r.lang@sak.at
Study Locations
-
-
-
Graz, Austria, 8020
- Recruiting
- Universitätsklinikum Graz - LKH, Klinische Abteilung für Onkologie
-
Contact:
- Philipp Jost, MD
- Email: philipp.jost@medunigraz.at
-
Innsbruck, Austria, 6020
- Recruiting
- LKH Innsbruck Universitätsklinik für Dermatologie und Venerologie
-
Contact:
- Van Anh Nguyen, MD
- Email: van.nguyen@i-med.ac.at
-
Klagenfurt, Austria, 9020
- Completed
- Klinikum Klagenfurt am Wörthersee
-
Salzburg, Austria, 5020
- Recruiting
- Universitätsklinik für Dermatologie und Allergologie der Paracelsus medizinischen Privatuniversität Salzburg
-
Contact:
- Martin Laimer, MD
- Phone Number: 58274 +4357255
- Email: m.laimer@salk.at
-
Contact:
- Roland Lang, PhD
- Phone Number: 58200 +4357255
- Email: r.lang@salk.at
-
St.Pölten, Austria, 3100
- Recruiting
- Abteilung für Haut- und Geschlechtskrankheiten, Universitätsklinikum St. Pölten Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
-
Contact:
- Christine Hafner, MD
- Email: christine.hafner@edu.kl.ac.at
-
Vienna, Austria, 1090
- Recruiting
- Med Uni Wien, Univ. Klinik für Dermatologie
-
Contact:
- Christoph Höller, MD
- Email: christoph.hoeller@meduniwien.ac.at
-
Wels, Austria, 4600
- Recruiting
- Klinikum Wels-Grieskirchen GmbH
-
Contact:
- Matthias Barta, MD
- Email: matthias.barta@klinikum-wegr.at
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: up to 5 years
|
using Response Criteria in Solid Tumors Version 1.1 (RECIST1.1)
per site assessment
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: up to 5 years
|
up to 5 years
|
|
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
|
up to 5 years
|
Duration of Response (DOR) in patients who achieve partial response (PR) or better
Time Frame: up to 5 years
|
up to 5 years
|
|
Progression Free Survival (PFS)
Time Frame: up to 5 years
|
up to 5 years
|
|
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
|
up to 5 years
|
|
Number and severity of adverse events
Time Frame: up to 5 years
|
up to 5 years
|
|
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
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Laimer, MD, Salzburger Landeskliniken
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2017
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
December 17, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (Actual)
December 19, 2019
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Skin Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
- Relatlimab
Other Study ID Numbers
- CA209-587
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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