Clinical trial • Phase II • Oncology
Clinical trial in Cancer (pan-tumor)
Phase II trial for Cancer (pan-tumor). None/Not specified-controlled. 281 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cancer (pan-tumor)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 05-06-2024
Trial design
None/Not specified-controlled Phase II trial in France, Belgium, Germany and others.
- Comparator
- None/Not specified
- Target Sample Size
- 281
Eligibility
Recruits 281 The protocol excludes certain vulnerable populations or restricts participation: prisoners or participants who are involuntarily incarcerated are excluded (with a note that under very specific local regulations and with strict conditions and BMS approval an imprisoned person may be included). Participants compulsorily detained for treatment (psychiatric or physical) are excluded. Participants with dementia or serious psychiatric conditions that may compromise the informed consent process are excluded. Overall the trial metadata indicates vulnerable populations are not selected (isVulnerablePopulationSelected = false) and the consent requirement is signed written informed consent from the participant..
- Vulnerable Population
- The protocol excludes certain vulnerable populations or restricts participation: prisoners or participants who are involuntarily incarcerated are excluded (with a note that under very specific local regulations and with strict conditions and BMS approval an imprisoned person may be included). Participants compulsorily detained for treatment (psychiatric or physical) are excluded. Participants with dementia or serious psychiatric conditions that may compromise the informed consent process are excluded. Overall the trial metadata indicates vulnerable populations are not selected (isVulnerablePopulationSelected = false) and the consent requirement is signed written informed consent from the participant.
Inclusion criteria
- {"criterion_text":"- Signed Written Informed Consent\n- Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.\n- Participant is eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.\n- Participant is on treatment hold in the Parent Study following longlasting response or are eligible for treatment rechallenge as defined in the Parent Study."}
Exclusion criteria
- {"criterion_text":"- For Participants planning to enter the study on nivolumab treatment: Participant is not eligible for study treatment per the Parent Study eligibility criteria\n- Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the participant.\n- In the case of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptoms must have completely resolved and based on investigator assessment, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.\n- Participants currently in other interventional trials, including those for coronavirus disease 2019 (COVID-19), may not participate in BMS clinical trials until the protocol-specific washout period is achieved. If a study participant has received an investigational COVID-19 vaccine or other investigational product designed to treat or prevent COVID-19 prior to screening, enrollment must be delayed until the biologic impact of the vaccine or investigational product is stabilized, as determined by the investigator\n- Participants not receiving clinical benefit as assessed by the Investigator\n- Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant\n- History of allergy or hypersensitivity to study drug components\n- Prisoners or participants who are involuntarily incarcerated (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and BMS approval is required\n- Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness\n- Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths).","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- OS defined as date of randomization, first dose, or as defined in the Parent Study until date of death from any cause or censored on the last known alive date in the rollover study","definition_or_measurement_approach":"OS defined as date of randomization, first dose, or as defined in the Parent Study until date of death from any cause or censored on the last known alive date in the rollover study"}
- {"endpoint_text":"- Incidence of AEs.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 281
- Recruitment Window Months
- 123
- Consent Approach
- Signed written informed consent is required from participants. Multiple language versions of the subject information and informed consent form (L1 SIS and ICF) are provided (document list includes English, French, Spanish, Greek, Polish, Romanian, Italian, Dutch and others). Supplemental ICFs are provided for specific treatment arms and a Pregnant Partner ICF is available. No assent/parental consent process for minors is specified in the available documentation.
Geography
France
- Latest Decision Or Authorization Date
- 24-06-2024
- Number Of Sites
- 11
- Number Of Participants
- 36
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Dermatologie, Allergologie et Photobiologie
- Contact Person Name
- Julie CHARLES
- Contact Person Email
- JCharles@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Contact Person Name
- Pierre CORNILLON
- Contact Person Email
- Pierre.Cornillon@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Departement de Dermatologie
- Contact Person Name
- Stephane DALLE
- Contact Person Email
- stephane.dalle@chu-lyon.fr
- Site Name
- Hospital Foch
- Department Name
- Service d’Oncologie Medicale
- Contact Person Name
- Christine ABRAHAM
- Contact Person Email
- c.abraham@hopital-foch.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service de Dermatologie – Pavillon 4
- Contact Person Name
- Caroline GAUDY
- Contact Person Email
- caroline.gaudy@ap-hm.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Departement d Oncologie Medicale
- Contact Person Name
- Coureche KADERBHAI
- Contact Person Email
- cgkaderbhai@cgfl.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Service d Oncologie
- Contact Person Name
- Hakim MAHAMMEDI
- Contact Person Email
- hakim.mahammedi@clermont.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement de Dermatologie
- Contact Person Name
- Caroline ROBERT
- Contact Person Email
- caroline.robert@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Departement d Hematologie Clinique
- Contact Person Name
- Franciane PAUL
- Contact Person Email
- f-paul@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service de Dermatologie
- Contact Person Name
- Gaelle QUEREUX
- Contact Person Email
- gaelle.quereux@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Clinique Dermatologique
- Contact Person Name
- Laurent MORTIER
- Contact Person Email
- Laurent.mortier@chru-lille.fr
Belgium
- Latest Decision Or Authorization Date
- 05-06-2024
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Department of Medicine, Division of Pulmonology
- Contact Person Name
- Sebahat Ocak
- Contact Person Email
- sebahat.ocak@uclouvain.be
Germany
- Latest Decision Or Authorization Date
- 12-06-2024
- Number Of Sites
- 11
- Number Of Participants
- 34
Austria
- Latest Decision Or Authorization Date
- 09-06-2024
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Urologie
- Contact Person Name
- Clemens Mayr
- Contact Person Email
- Clemens.Mayr@ordensklinikum.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine III, Division of Gastroenterology and Hepatology
- Contact Person Name
- Matthias Pinter
- Contact Person Email
- matthias.pinter@meduniwien.ac.at
Spain
- Latest Decision Or Authorization Date
- 07-06-2024
- Number Of Sites
- 17
- Number Of Participants
- 68
Italy
- Latest Decision Or Authorization Date
- 17-06-2024
- Number Of Sites
- 10
- Number Of Participants
- 37
Romania
- Latest Decision Or Authorization Date
- 10-06-2024
- Number Of Sites
- 5
- Number Of Participants
- 77
Poland
- Latest Decision Or Authorization Date
- 05-06-2024
- Number Of Sites
- 7
- Number Of Participants
- 43
Czechia
- Latest Decision Or Authorization Date
- 10-06-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Department of Oncology and Radiotherapy
- Contact Person Name
- Jindrich Kopecky
- Contact Person Email
- jindrich.kopecky@fnhk.cz
Greece
- Latest Decision Or Authorization Date
- 22-08-2024
- Number Of Sites
- 5
- Number Of Participants
- 3
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Oncology-Hematology Department, Department of Clinical Therapeutics
- Contact Person Name
- Michael Liontos
- Contact Person Email
- mliontos@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 management, site management, site startup, SAE receipt and processing, safety reporting
- Name
- Icon Laboratory Services Inc.
- Responsibilities
- Local laboratory data entry and routine clinical pathology testing and assay services
Third parties
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Data entry of Local Laboratory Values, Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, Histopathology, Serology/ endocrinology, Analytical chemistry, Primary/ surrogate endpoint test","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Project management, site management, site startup, SAE receipt and processing, safety reporting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients.","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Combination Treatment
- Yes
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