GSK Clinical Trials Study Director GlaxoSmithKline
Kontakt
US GSK Clinical Trials Call Center Kontakt: Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com» Kontaktdaten anzeigen EU GSK Clinical Trials Call Center Kontakt: Phone: +44 (0) 20 89904466 E-Mail: GSKClinicalSupportHD@gsk.com» Kontaktdaten anzeigen
Studienlocations (3 von 58)
GSK Investigational Site 69126 Heidelberg (Baden-Württemberg) GermanyAbgeschlossen» Google-MapsGSK Investigational Site 82131 Gauting (Bayern) GermanyAbgeschlossen» Google-MapsGSK Investigational Site 34376 Immenhausen (Hessen) GermanyAbgeschlossen» Google-Maps
GSK Investigational Site 34125 Kassel (Hessen) GermanyAbgeschlossen» Google-MapsGSK Investigational Site 04357 Leipzig (Sachsen) GermanyAbgeschlossen» Google-MapsGSK Investigational Site 22927 Grosshansdorf (Schleswig-Holstein) GermanyRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 14165 Berlin (Berlin) GermanyAbgeschlossen» Google-MapsGSK Investigational Site 90025 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 63110-1093 Saint Louis United StatesAbgeschlossen» Google-MapsGSK Investigational Site 10461-2375 Bronx United StatesRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 10467 Bronx United StatesRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 28374 Pinehurst United StatesAbgeschlossen» Google-MapsGSK Investigational Site 37404 Chattanooga United StatesRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 37203 Nashville United StatesRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 75230 Dallas United StatesAbgeschlossen» Google-MapsGSK Investigational Site T6G 1Z2 Edmonton CanadaRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site L6R 3J7 Brampton CanadaRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site M5G 2M9 Toronto CanadaRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 33076 Bordeaux Cedex FranceRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 14033 Caen Cedex 9 FranceAbgeschlossen» Google-MapsGSK Investigational Site 44093 Nantes cedex 1 FranceAbgeschlossen» Google-MapsGSK Investigational Site 75248 Paris Cedex 05 FranceRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 75018 Paris FranceRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 94805 Villejuif Cedex FranceRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 80131 Napoli ItalyAbgeschlossen» Google-MapsGSK Investigational Site 47014 Meldola (FC) ItalyRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 48121 Ravenna ItalyRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 20133 Milano ItalyRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 10043 Orbassano (TO) ItalyAbgeschlossen» Google-MapsGSK Investigational Site 53100 Siena ItalyRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 28644 Cheongju-si, Chungcheongbuk-do Korea, Republic ofAbgeschlossen» Google-MapsGSK Investigational Site 10408 Gyeonggi-do Korea, Republic ofAbgeschlossen» Google-MapsGSK Investigational Site 13620 Seongnam Korea, Republic ofAbgeschlossen» Google-MapsGSK Investigational Site 05505 Seoul Korea, Republic ofAbgeschlossen» Google-MapsGSK Investigational Site 1081 HV Amsterdam NetherlandsAbgeschlossen» Google-MapsGSK Investigational Site 6229 HX Maastricht NetherlandsAbgeschlossen» Google-MapsGSK Investigational Site 93-513 Lodz PolandAbgeschlossen» Google-MapsGSK Investigational Site 60-569 Poznan PolandAbgeschlossen» Google-MapsGSK Investigational Site 02-781 Warszawa PolandAbgeschlossen» Google-MapsGSK Investigational Site 020142 Bucharest RomaniaAbgeschlossen» Google-MapsGSK Investigational Site 200347 Craiova RomaniaAbgeschlossen» Google-MapsGSK Investigational Site 407280 Floresti RomaniaAbgeschlossen» Google-MapsGSK Investigational Site 075100 Otopeni RomaniaAbgeschlossen» Google-MapsGSK Investigational Site 300166 Timisoara RomaniaAbgeschlossen» Google-MapsGSK Investigational Site 454048 Chelyabinsk Russian FederationAbgeschlossen» Google-MapsGSK Investigational Site 194291 Saint-Petersburg Russian FederationAbgeschlossen» Google-MapsGSK Investigational Site 197183 Saint-Petersburg Russian FederationAbgeschlossen» Google-MapsGSK Investigational Site 06080 Badajoz SpainAbgeschlossen» Google-MapsGSK Investigational Site 08035 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 08036 Barcelona SpainAbgeschlossen» Google-MapsGSK Investigational Site 28027 Madrid SpainAbgeschlossen» Google-MapsGSK Investigational Site 28033 Madrid SpainAbgeschlossen» Google-MapsGSK Investigational Site 28034 Madrid SpainRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 29010 Málaga SpainRekrutierend» Google-Maps Ansprechpartner: US GSK Clinical Trials Call Center Phone: 877-379-3718 E-Mail: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre Phone: +44 (0) 20 8990 4466 E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigenGSK Investigational Site 39008 Santander SpainAbgeschlossen» Google-MapsGSK Investigational Site 41009 Sevilla SpainAbgeschlossen» Google-MapsGSK Investigational Site SE-171 64 Solna SwedenAbgeschlossen» Google-MapsGSK Investigational Site SE- 75 185 Uppsala SwedenAbgeschlossen» Google-Maps
1. Part 1: Number of participants with any adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Up to 2 years)
2. Part 1: Number of participants with dose limiting toxicity (DLT) (Time Frame - Up to 2 years)
3. Part 1: Number of participants with clinically significant changes in vital signs, physical examination and laboratory parameters (Time Frame - Up to 2 years)
4. Part 1: Number of participants requiring dose modifications (Time Frame - Up to 2 years)
5. Part 2: Overall survival (Time Frame - Up to 3 years): Overall survival will be calculated as time from randomization to death.
Secondary outcome:
1. Part 1: Objective response rate (Time Frame - Up to 2 years): Objective response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria.
2. Part 1: Disease control rate (DCR) (Time Frame - Up to 2 years): DCR is defined as the percentage of participants with a best overall confirmed CR, PR or stable disease (SD) at any time as per disease-specific criteria.
3. Part 1: Maximum observed concentration (Cmax) and Minimum observed concentration (Cmin) of feladilimab (Time Frame - Up to 2 years)
4. Part 1: Cmax and Cmin of ipilimumab (Time Frame - Up to 2 years)
5. Part 1: Cmax and Cmin of GSK4428859A/EOS884448/belrestotug (Time Frame - Up to 2 years)
6. Part 1: Cmax and Cmin of dostarlimab (Time Frame - Up to 2 years)
7. Part 1: Cmax and Cmin of GSK6097608 (Time Frame - Up to 2 years)
8. Part 2: Survival rate at 12 and 18 months (Time Frame - At 12 and 18 months): Milestone survival rate of participants treated with experimental regimens versus SoC therapy.
9. Part 2: Number of participants with CR, Partial response (PR), Stable disease (SD) and Progressive disease (PD) (Time Frame - Up to 2 years): CR, PR, SD and PD will be evaluated as per RECIST version 1.1 criteria.
10. Part 2: Progression-free survival (PFS) (Time Frame - Up to 2 years): PFS is defined as time from the date of randomization to the date of disease progression or death whichever occurs earlier.
11. Part 2: Objective response rate (ORR) (Time Frame - Up to 2 years): ORR is defined as the percentage of participants with a confirmed CR or PR at any time per RECIST version 1.1 criteria.
12. Part 2: Duration of response (DOR) (Time Frame - Up to 2 years): DOR is defined as the first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria.
13. Part 2: DCR (Time Frame - Up to 2 years): DCR is defined as the percentage of participants with a best overall confirmed CR, PR or SD at any time as per disease-specific criteria.
14. Part 2: Number of participants with immune-based (i) iCR, iPR, unconfirmed progressive disease (iUPD), confirmed progressive disease (iCPD), and iSD (Time Frame - Up to 2 years): Number of participants with iCR, iPR, iUPD, iCPD and iSD per modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria.
15. Part 2: Progression-free survival (iPFS) (Time Frame - Up to 2 years): iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria.
16. Part 2: Objective response rate (iORR) (Time Frame - Up to 2 years): iORR is defined as the percentage of participants with a confirmed CR or PR at any time per iRECIST criteria.
17. Part 2: Duration of response (iDOR) (Time Frame - Up to 2 years): iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria.
18. Part 2: Number of participants with AEs, adverse events of special interest (AESI), SAEs and AE/SAEs leading to dose modifications/delays/withdrawals (Time Frame - Up to 2 years)
19. Part 2: Number of participants with clinically significant changes in vital signs, physical examination and laboratory parameters (Time Frame - Up to 2 years)
20. Part 2: Cmax and Cmin for SoC (docetaxel) (Time Frame - Up to 2 years)
21. Part 2: Cmax and Cmin for feladilimab (Time Frame - Up to 2 years)
22. Part 2: Number of participants with positive anti-drug antibodies (ADA) against docetaxel (Time Frame - Up to 2 years)
23. Part 2: Number of participants with positive ADA against feladilimab (Time Frame - Up to 2.5 years)