Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)
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Studienlocations (3 von 25)
U. klinikum Koeln AOER ( Site 0326) 50937 Koeln (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +4922147897657» Ansprechpartner anzeigenUniversitaetsklinikum Leipzig AOeR ( Site 0327) 4103 Leipzig (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +493419720363» Ansprechpartner anzeigenBanner MD Anderson Cancer Center ( Site 0020) 85234 Gilbert United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 480-256-3425» Ansprechpartner anzeigen
City of Hope ( Site 0001) 91010 Duarte United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 626-256-2405» Ansprechpartner anzeigenRonald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007) 90095 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 310-582-4067» Ansprechpartner anzeigenPacific Cancer Care ( Site 0006) 93940 Monterey United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of California San Francisco ( Site 0023) 94143 San Francisco United StatesRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 415-885-3882» Ansprechpartner anzeigenDana Farber Cancer Institute ( Site 0002) 02215 Boston United StatesAktiv, nicht rekrutierend» Google-MapsFox Chase Cancer Center ( Site 0019) 19111 Philadelphia United StatesAbgeschlossen» Google-MapsTexas Oncology-Austin Midtown ( Site 8002) 78705 Austin United StatesAbgeschlossen» Google-MapsConcord Repatriation & General Hospital ( Site 0203) 2139 Concord AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61397677341» Ansprechpartner anzeigenPrincess Alexandra Hospital ( Site 0204) 4102 Woollongabba AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61731766826» Ansprechpartner anzeigenMonash Health ( Site 0201) 3168 Clayton AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61395946666» Ansprechpartner anzeigenSt Vincent s Hospital (Melbourne) Limited ( Site 0202) 3065 Fitzroy AustraliaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +61398593936» Ansprechpartner anzeigenBC Cancer ( Site 0107) V5Z 1L3 Vancouver CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 6048776000» Ansprechpartner anzeigenCancerCare Manitoba ( Site 0101) R3E 0V9 Winnipeg CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 2047874156» Ansprechpartner anzeigenPrincess Margaret Cancer Centre ( Site 0100) M5G 2M9 Toronto CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 4169464501» Ansprechpartner anzeigenJewish General Hospital ( Site 0105) H3T 1E2 Montreal CanadaRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: 5143408222 x 24572» Ansprechpartner anzeigenRambam Medical Center ( Site 0382) 3109601 Haifa IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97247773109» Ansprechpartner anzeigenHadassah Ein Karem Jerusalem ( Site 0383) 9112001 Jerusalem IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97226778243» Ansprechpartner anzeigenChaim Sheba Medical Center. ( Site 0380) 5262001 Ramat Gan IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97235302588» Ansprechpartner anzeigenSourasky Medical Center ( Site 0381) 64239 Tel Aviv IsraelRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +97236973782» Ansprechpartner anzeigenA.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0351) 40138 Bologna ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390516363680» Ansprechpartner anzeigenIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0354) 47014 Meldola ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390543739290» Ansprechpartner anzeigenHumanitas-U.O di Oncologia medica ed Ematologia ( Site 0352) 20089 Rozzano ItalyRekrutierend» Google-Maps Ansprechpartner: Study Coordinator Phone: +390282244080» Ansprechpartner anzeigen
1. Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT) (Time Frame - Cycle 1 (up to 21 days)): DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle and reported as the percentage of participants experiencing a DLT defined by the National Cancer Institute Common Terminology for Adverse Events version 4.0.
2. Percentage of Participants Experiencing an Adverse Event (AE) (Time Frame - From time of signing informed consent form (ICF) until the end of follow-up (up to approximately 27 months)): Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
3. Percentage of Participants with Treatment Discontinuations Due to an AE (Time Frame - From time of signing informed consent form (ICF) until the end of study treatment (up to approximately 24 months)): Percentage of participants discontinuing study treatment due to an AE
Secondary outcome:
1. Objective Response Rate (ORR) (Time Frame - Up to approximately 24 months): ORR is defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per lymphoma disease response criteria (Cheson et. al., 2007) as assessed by the investigator.
2. Serum Concentration of Favezelimab (Time Frame - At designated time points (Up to approximately 25 months)): Blood samples will be collected at designated time points for the determination of the serum concentration of favezelimab. For Cycles 1 and 8: Day 1 at predose, end of infusion, and 4 hours postdose; Days 8 and 15 at any time. Cycles 2 through 7, Cycles 9 through 16 and every 4 cycles thereafter: Day 1 at predose. Blood samples will also be collected at the 30-day follow-up visit.
3. Serum Concentration of Pembrolizumab (Time Frame - At designated time points (Up to approximately 25 months)): Blood samples will be collected at designated time points for the determination of the serum concentration of pembrolizumab. For Cycles 1 and 8: Day 1 at predose, end of infusion, and 4 hours postdose; Days 8 and 15 at any time. Cycles 2 through 7, Cycles 9 through 16 and every 4 cycles thereafter: Day 1 at predose. Blood samples will also be collected at the 30-day follow-up visit.
Experimental: Part A: Favezelimab Dose A+pembrolizumab Participants receive 200 mg pembrolizumab by intravenous (IV) infusion followed by favezelimab Dose A by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part A: Favezelimab Dose B+pembrolizumab Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose B by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part A: Favezelimab Dose C+Pembrolizumab Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose C by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: cHL-Combination Therapy Participants with cHL receive 200 mg pembrolizumab by IV infusion followed by the recommended Phase 2 dose (RP2D) of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: DLBCL-Combination Therapy Participants with DLBCL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: iNHL-Combination Therapy Participants with iNHL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: Randomized cHL-Monotherapy Participants with cHL receive either pembrolizumab by IV infusion or the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to approximately 2 years).
pembrolizumab (KEYTRUDA® / MK-3475 / ): Administered as an IV infusion every 3 weeks (Q3W)
Favezelimab (MK-4280): Administered as an IV infusion Q3W
Quelle: ClinicalTrials.gov
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"Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)"
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