Clinical trial • Phase II • Oncology
RELATLIMAB for Non-small cell lung cancer
Phase II trial of RELATLIMAB for Non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 26-03-2024
- First CTIS Authorization Date
- 06-05-2024
Trial design
Randomised, open-label, nivolumab in combination with chemotherapy (chemotherapy agents listed in the trial include paclitaxel albumin-bound, paclitaxel, carboplatin, cisplatin, pemetrexed disodium). specific doses and schedules are not specified in the available record.-controlled, adaptive Phase II trial in Italy, Netherlands, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Nivolumab in combination with chemotherapy (chemotherapy agents listed in the trial include paclitaxel albumin-bound, paclitaxel, carboplatin, cisplatin, pemetrexed disodium). Specific doses and schedules are not specified in the available record.
- Adaptive
- True, Part 1 includes dose-safety evaluation with two dose levels of relatlimab (360 mg and 720 mg) in combination with nivolumab and chemotherapy (dose confirmation/escalation elements described).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 175
Eligibility
Recruits 175 Vulnerable population selected. Participants are adults (≥ 18 years of age or local age of majority). Informed consent is obtained using subject information and informed consent forms (multiple country-specific ICF documents are listed in the trial documents). No assent procedures for minors are described (minors are excluded by the ≥18 years inclusion criterion)..
- Pregnancy Exclusion
- Women who are pregnant or breastfeeding.
- Vulnerable Population
- Vulnerable population selected. Participants are adults (≥ 18 years of age or local age of majority). Informed consent is obtained using subject information and informed consent forms (multiple country-specific ICF documents are listed in the trial documents). No assent procedures for minors are described (minors are excluded by the ≥18 years inclusion criterion).
Inclusion criteria
- {"criterion_text":"- Males and females; ≥ 18 years of age or local age of majority."}
- {"criterion_text":"- Histologically confirmed metastatic NSCLC of squamous (SQ) or nonsquamous (NSQ) histology with Stage IV or recurrent disease following multi-modal therapy for locally advanced disease."}
- {"criterion_text":"- Measurable disease by computed tomography or magnetic resonance imaging per Response"}
- {"criterion_text":"- Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization."}
- {"criterion_text":"- No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease."}
- {"criterion_text":"- ECOG PS of less than or equal to 1 at screening and confirmed prior to randomization."}
- {"criterion_text":"- Participants must have a life expectancy of at least 3 months at the time of first dose."}
- {"criterion_text":"- A formalin-fixed paraffin-embedded tissue block containing enough tissue to cut 20 sections (preferred) or a minimum of 20 unstained slides of tumor tissue from core biopsy, punch biopsy, excisional biopsy, or surgical specimen obtained during screening or prior to enrollment (within 3 months of enrollment if stored at 2-8°C or within 2 months of enrollment if stored at ambient temperature and with no intervening systemic anti-cancer treatment between time of acquisition and enrollment) must be sent to the central laboratory."}
- {"criterion_text":"- Participants must have PD-L1 immunohistochemistry (IHC) results from a central laboratory during the screening period prior to randomization."}
Exclusion criteria
- {"criterion_text":"- Women who are pregnant or breastfeeding."}
- {"criterion_text":"- Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to available targeted inhibitor therapy. All participants with NSQ histology must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ histology and unknown EGFR, ALK, or ROS-1 status are excluded."}
- {"criterion_text":"- Participants with known BRAFV600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible."}
- {"criterion_text":"- Participants with untreated central nervous system metastases."}
- {"criterion_text":"- Participants with leptomeningeal metastases (carcinomatous meningitis)."}
- {"criterion_text":"- Concurrent malignancy requiring treatment."}
- {"criterion_text":"- Participants with an active, known, or suspected autoimmune disease."}
- {"criterion_text":"- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways."}
- {"criterion_text":"- Participants with history of myocarditis."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part 1 •TRAEs leading to discontinuation within 12 weeks after the first dose","definition_or_measurement_approach":"TRAEs (treatment-related adverse events) leading to discontinuation measured within 12 weeks after the first dose (safety evaluable participants)."}
- {"endpoint_text":"- Part 2 •ORR per RECIST v1.1 by BICR","definition_or_measurement_approach":"Objective response rate (ORR) assessed per RECIST v1.1 by Blinded Independent Central Review (BICR)."}
Secondary endpoints
- {"endpoint_text":"- Part 1 •Incidence of TRAEs leading to discontinuation, AEs, SAEs, and select AEs","definition_or_measurement_approach":"Incidence rates of treatment-related adverse events (TRAE) leading to discontinuation, adverse events (AEs), serious adverse events (SAEs), and selected AEs; measured during the Part 1 safety evaluation period."}
- {"endpoint_text":"- Part 2 •PFS per RECIST v1.1 by BICR","definition_or_measurement_approach":"Progression-free survival (PFS) assessed per RECIST v1.1 by Blinded Independent Central Review (BICR)."}
Recruitment
- Planned Sample Size
- 175
- Recruitment Window Months
- 61
- Consent Approach
- Informed consent is obtained from each participant using subject information sheets and informed consent forms. Multiple country-specific ICF documents and language versions are provided in the trial documents (ICFs listed for Italy, Netherlands, Poland, Germany, Spain, Ireland, Belgium, France, Romania, etc.). Participants are adults (≥18) and provide their own consent; no assent for minors is described.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 288
Italy
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 13-05-2024
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 23
Sites
- Site Name
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Department Name
- U.O.C. Oncologia
- Contact Person Name
- Rita Chiari
- Contact Person Email
- rita.chiari@ospedalimarchenord.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 06-05-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Ziekenhuis St Jansdal
- Department Name
- Pulmonology
- Contact Person Name
- Lisenka Boom
- Contact Person Email
- ln.boom@stjansdal.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Pulmonology
- Contact Person Name
- Niels Claessens
- Contact Person Email
- nclaessens@rijnstate.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 07-05-2024
- Processing Time Days
- 20
- Number Of Sites
- 4
- Number Of Participants
- 81
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Pluca i Klatki Piersiowej
- Contact Person Name
- Adam Pluzanski
- Contact Person Email
- sekretariat4@nio.gov.pl
- Site Name
- Mandziuk Slawomir - Specjalistyczna Praktyka Lekarska
- Department Name
- Specialized medical practice
- Contact Person Name
- Slawomir Mandziuk
- Contact Person Email
- slawman7@wp.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Klinika Pneumonologii, Onkologii i Alergologii
- Contact Person Name
- Janusz Milanowski
- Contact Person Email
- szpital@spsk4.lublin.pl
- Site Name
- Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
- Department Name
- Oddzial Onkologii z Pododzialem Chemioterapii
- Contact Person Name
- Andrzej Kazarnowicz
- Contact Person Email
- sekretariat@pulmonologia.olsztyn.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 13-05-2024
- Processing Time Days
- 26
- Number Of Sites
- 6
- Number Of Participants
- 29
Sites
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Medizinisches Versorgungszentrum Haematologie und Onkologie Essen
- Contact Person Name
- Sebastian W. Ertl
- Contact Person Email
- s.ertl@kem-med.com
- Site Name
- MVZ fuer Haematologie und Onkologie Ravensburg GmbH
- Contact Person Name
- Tobias Dechow
- Contact Person Email
- dechow@onkonet.eu
- Site Name
- Philipps-Universitaet Marburg
- Contact Person Name
- Charis Faoro
- Contact Person Email
- faoro@staff.uni-marburg.de
- Site Name
- SLK-Kliniken Heilbronn GmbH
- Department Name
- Medizinische Klinik II, Onkologie
- Contact Person Name
- Jonas Kuon
- Contact Person Email
- jonas.kuon@klink-loewenstein.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Clinic for Internal Medicine - Haematology, Oncology, Gastroenterology and Palliative Medicine
- Contact Person Name
- Jan Eucker
- Contact Person Email
- jan.euker@vivantes.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Contact Person Name
- Martin Reck
- Contact Person Email
- M.Reck@lungenclinic.de
Spain
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 13-05-2024
- Processing Time Days
- 26
- Number Of Sites
- 10
- Number Of Participants
- 56
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- Contact Person Name
- Javier de Castro Carpeno
- Contact Person Email
- jcastro.hulp@salud.madrid.org
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Enric Carcereny Costa
- Contact Person Email
- ecarcereny@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Contact Person Name
- Luis Gonzaga Paz-Ares Rodriguez
- Contact Person Email
- lpazares@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Contact Person Name
- Noemi Reguart Aransay
- Contact Person Email
- nreguart@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Reyes Bernabe Caro
- Contact Person Email
- reyesbernab@yahoo.es
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Medical Oncology
- Contact Person Name
- Delvys Rodriguez Abreu
- Contact Person Email
- delvysra@yahoo.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medical Oncology
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Contact Person Name
- Oscar Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
Ireland
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 07-05-2024
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Beaumont Hospital
- Department Name
- Medical Oncology
- Contact Person Name
- Jarushka Naidoo
- Contact Person Email
- jarushkanaidoo@beaumont.ie
- Site Name
- St Vincent's University Hospital
- Department Name
- Medical Oncology
- Contact Person Name
- Emer Hanrahan
- Contact Person Email
- e.hanrahan@st-vincents.ie
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 07-05-2024
- Processing Time Days
- 20
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Az Maria Middelares Gent
- Department Name
- Pneumology
- Contact Person Name
- Paul Germonpre
- Contact Person Email
- paul.germonpre@azmmsj.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Pulmonary Medicine
- Contact Person Name
- Karim Vermaelen
- Contact Person Email
- Karim.vermaelen@ugent.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Pneumology
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- Ingel.demedts@azdelta.be
France
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 56
- Number Of Sites
- 7
- Number Of Participants
- 39
Sites
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hopital Pontchaillou, service de pneumologie
- Contact Person Name
- Herve LENA
- Contact Person Email
- herve.lena@chu-rennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Cochin)
- Department Name
- Hopital Cochin, service de pneumologie
- Contact Person Name
- Marie WISLEZ
- Contact Person Email
- marie.wislez@aphp.fr
- Site Name
- Institut Curie
- Department Name
- Unite d investigation clinique – D31
- Contact Person Name
- Nicolas GIRARD
- Contact Person Email
- nicolas.girard2@curie.fr
- Site Name
- Unite De Recherche Clinique HIA Begin
- Department Name
- Unite de recherche clinique, 1er etage - Aile EST
- Contact Person Name
- Carole HELISSEY DANIS
- Contact Person Email
- carole.helissey@gmail.com
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Service de pneumologie – Maladies respiratoires
- Contact Person Name
- Olivier MOLINIER
- Contact Person Email
- omolinier@ch-lemans.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Service de pneumologie
- Contact Person Name
- Clea Fraisse
- Contact Person Email
- cfraisse@cgfl
- Site Name
- Assistance Publique Hopitaux De Paris (Bichat)
- Department Name
- Hopital Bichat, service d oncologie thoracique
- Contact Person Name
- Valerie GOUNANT
- Contact Person Email
- valerie.gounant@aphp.fr
Romania
- Earliest CTIS Part Ii Submission Date
- 17-04-2024
- Latest Decision Or Authorization Date
- 13-05-2024
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Oncolab S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Dan Lungulescu
- Contact Person Email
- dan.lungulescu@yahoo.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Medical Oncology
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
- Site Name
- Onco Clinic Consult S.A.
- Department Name
- Medical Oncology
- Contact Person Name
- Patricia Visan
- Contact Person Email
- p.visan@oncoclinic.ro
- Site Name
- Oncocenter Oncologie Clinica S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Roxana-Ioana Scheusan
- Contact Person Email
- Roxana.scheusan@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Project and site management, site startup, SAE receipt & processing, safety reporting
Third parties
- {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Exploratory Serum Biomarkers analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Serum and plasma biomarker analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"submission administrative support","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited (second address)","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Project and site management, site startup, SAE receipt & processing, safety reporting","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sample storage for biomarker Storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"Specialty Biomarker Testing Lab","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"Serum PK and Serum immunogenicity assay (nivolumab and relatlimab)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"IHC Biomarker expression analysis (PD-L1)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- RELATLIMAB
- Active Substance
- RELATLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Investigational (no marketing authorisation listed)
- Starting Dose
- 360 mg (Part 1 dose levels include 360 mg and 720 mg)
- Dose Levels
- 360 mg and 720 mg
- Dose Escalation Increase
- 360 mg and 720 mg
- Investigational Product Name
- NIVOLUMAB (OPDIVO 10 mg/mL concentrate for solution for infusion.)
- Active Substance
- NIVOLUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation EU/1/15/1014/002 (as listed for OPDIVO in product data)
- Investigational Product Name
- PACLITAXEL ALBUMIN-BOUND
- Active Substance
- PACLITAXEL ALBUMIN-BOUND
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- Infusion
- Authorisation Status
- No marketing authorisation listed in product entry
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- No marketing authorisation listed in product entry
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- No marketing authorisation listed in product entry
- Investigational Product Name
- PEMETREXED DISODIUM
- Active Substance
- PEMETREXED DISODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- No marketing authorisation listed in product entry
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- No marketing authorisation listed in product entry
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.