A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
University Medical Center Mannheim 68167 Mannheim (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversity Hospital Tuebingen 72076 Tubingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsHautklinik Universitatsklinikum Erlangen 91054 Erlangen (Bayern) GermanyRekrutierend» Google-Maps
LMU Klinikum Munchen, Pharmacy 80337 Munchen (Bayern) GermanyRekrutierend» Google-MapsKlinikum Darmstadt GmbH 64283 Darmstadt (Hessen) GermanyRekrutierend» Google-MapsUniversitatsmedizin Gottingen 37075 Gottingen (Niedersachsen) GermanyRekrutierend» Google-MapsHelios Kliniken Schwerin GmbH, Apotheke 19055 Schwerin (Mecklenburg-Vorpommern) GermanyRekrutierend» Google-MapsUniversitaetstklinikum Muenster Central Study Coordination for innovative Dermatology (ZID) 48149 Muenster (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsHohenzollernapotheke 48157 Muenster (Nordrhein-Westfalen) GermanySchwebend» Google-MapsKlinikum der Stadt Ludwigshafen am Rhein 67063 Ludwigshafen (Rheinland-Pfalz) GermanyRekrutierend» Google-MapsHarzklinikum Dorothea Christiane Erxleben GmbH, Zentrale Krankenhausapotheke 06484 Quedlinburg (Sachsen-Anhalt) GermanyRekrutierend» Google-MapsUniversitatsklinikum Carl Gustav Carus Dresden, Klinik Apotheke - building 60 01307 Dresden (Sachsen) GermanyRekrutierend» Google-MapsUKSH-Campus Kiel 24105 Kiel (Schleswig-Holstein) GermanyRekrutierend» Google-MapsCampus Virchow Klinikum, Apotheke Zytostatika Studien, Charite - 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1. Relapse free survival (RSF) (Time Frame - Up to 5 Years): Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
Secondary outcome:
1. Distant metastasis-free survival (DMFS) (Time Frame - Up to 5 Years): Time between the date of randomization and the date of the first distant metastasis.
2. Overall survival (OS) (Time Frame - Up to 5 Years): Time from randomization to the date of death.
3. Occurrence of treatment-emergent adverse events (TEAEs) (Time Frame - Up to 5 Years): A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
4. Occurrence of immune-mediated EAEs (im-EAEs) (Time Frame - Up to 5 Years): imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.
5. Occurrence of serious adverse events (SAEs) (Time Frame - Up to 5 Years): An SAE is any untoward medical occurrence that at any dose:
Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger).
Is life-threatening
Requires in-patient hospitalization or prolongation of existing hospitalization.
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect.
Is an important medical event
6. Occurrence of adverse events of special interest (AESIs) (Time Frame - Up to 5 Years): An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
7. Occurrence of TEAEs resulting in death (Time Frame - Up to 5 Years): A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
8. Occurrence of dose-limiting toxicity (DLT) (Time Frame - Up to 5 Years): A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.
9. Occurrence of interruption or discontinuation of study drug(s) due to TEAE (Time Frame - Up to 5 Years): A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
10. Occurrence of laboratory abnormalities (Time Frame - Up to 5 Years): As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher)
11. Concentrations of fianlimab in serum over time (Time Frame - Up to 5 Years): The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
12. Concentrations of cemiplimab in serum over time (Time Frame - Up to 5 Years): The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
13. Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies (Time Frame - Up to 5 Years): Immunogenicity will be characterized per drug molecule by ADA and NAb status.
14. Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies (Time Frame - Up to 5 Years): Immunogenicity will be characterized per drug molecule by ADA and NAb status.
15. Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) (Time Frame - Up to 5 Year): The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
16. PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L) (Time Frame - Up to 5 Years): The EQ-5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
17. PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma (Time Frame - Up to 5 Years): The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).
18. PRO for adults as determined by the Patient Global Impressions Scale (PGIS) (Time Frame - Up to 5 Years): The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
19. PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC) (Time Frame - Up to 5 Years): The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".
20. Time to global health status/quality of life deterioration per EORTC QLQ-C30 (Time Frame - Up to 5 years)
21. Time to physical functioning deterioration per EORTC QLQ-C30 (Time Frame - Up to 5 Years)
22. Time to role functioning deterioration per EORTC QLQ-C30 (Time Frame - Up to 5 Years)
Fianlimab (REGN3767): Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
Cemiplimab (REGN2810 / Libtayo / ): Cemiplimab will be administered by IV infusion Q 3 weeks
Pembrolizumab (MK-3475 / lambrolizumab / Keytruda / ): Pembrolizumab will be administered by IV infusion Q 3 weeks
Placebo: Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks
Quelle: ClinicalTrials.gov
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"A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery"
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