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JOURNAL ONKOLOGIE – STUDIE
PIVOT-12

Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

Rekrutierend

NCT-Nummer:
NCT04410445

Studienbeginn:
Juli 2020

Letztes Update:
02.06.2021

Wirkstoff:
Bempegaldesleukin, Nivolumab

Indikation (Clinical Trials):
Melanoma, Recurrence

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
Nektar Therapeutics

Collaborator:
Bristol-Myers Squibb

Studienleiter

Mann Muhsin, MD
Study Director
Nektar Therapeutics

Kontakt

Studienlocations
(3 von 143)

Investigator Site - Site #2127
76297 Baden-Württemberg
(Baden-Württemberg)
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Investigator Site - Site #2143
Buxtehude
(Niedersachsen)
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Investigator Site - Site #2151
99089 Erfurt
(Thüringen)
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Investigator Site - Site #2149
Essen
(Nordrhein-Westfalen)
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Investigator Site - Site #2147
7548 Gera
(Thüringen)
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Investigator Site - Site #2154
Heilbronn
(Baden-Württemberg)
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Investigator Site - Site #2145
Mannheim
(Baden-Württemberg)
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Investigator Site - Site #2153
Münster
(Nordrhein-Westfalen)
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Investigator Site - Site #2157
Schwerin
(Mecklenburg-Vorpommern)
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Investigator Site - Site #9074
92805 Anaheim
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Investigator Site - Site #9076
92335 Fontana
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92835 Fullerton
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Investigator Site - Site #230
92868 Orange
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92868 Orange
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92373 Redlands
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92505 Riverside
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92505 Riverside
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94115 San Francisco
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92069 San Marcos
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92078 San Marcos
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90404 Santa Monica
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32750 Longwood
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60637 Chicago
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46526 Goshen
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40536 Lexington
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02114 Boston
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55905 Rochester
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63110 Saint Louis
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59102 Billings
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68114 Omaha
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68114 Omaha
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07960 Morristown
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35294 Binghamton
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10016 New York
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10021 New York
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27514 Chapel Hill
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27710 Durham
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44106 Cleveland
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97213 Portland
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18103 Allentown
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19107 Philadelphia
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29605 Greenville
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37920 Knoxville
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37203 Nashville
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37232 Nashville
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75246 Dallas
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90603 Salt Lake City
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22903 Charlottesville
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22031 Fairfax
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98405 Tacoma
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4870 Cairns
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4032 Chermside
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4120 Greenslopes
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6009 Nedlands
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6009 Nedlands
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2000 North Sydney
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4215 Southport
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4215 Southport
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2145 Westmead
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6830 Rankweil
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70852 Ostrava Poruba
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16000 Prague
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11526 Ampelokipoi
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18547 Athens
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18547 Athens
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71110 Heraklion
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15125 Maroúsi
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Investigator Site - Site #3022
54645 Thessaloníki
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56429 Thessaloníki
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86 Thessaloníki
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8410501 Be'er Sheva
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9574425 Jerusalem
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49100 Petah tikva
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47014 Meldola
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6419 Heerlen
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8934 Leeuwarden
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Investigator Site - Site #2712
3584 Utrecht
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Investigator Site - Site #2713
8025AB Zwolle
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Investigator Site - Site #1602
3084 Heidelberg
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Investigator Site - Site #1603
Tauranga
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Investigator Site - Site #2606
85796 Bydgoszcz
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Investigator Site - Site #2623
20064 Lublin
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Investigator Site - Site #3309
3004-561 Coimbra
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Investigator Site - Site #3308
1649-035 Lisboa
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Investigator Site - Site #3311
1649-035 Lisboa
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Investigator Site - Site #3312
1099-023 Lisbon
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Investigator Site - Site #3415
022328 Bucharest
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Investigator Site - Site #3414
400641 Cluj-Napoca
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Investigator Site - Site #3412
200396 Craiova
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Investigator Site - Site #3413
200008 Dolj
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Investigator Site - Site #3219
Chelyabinsk
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Investigator Site - Site #3232
Krasnodar
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Investigator Site - Site #3233
Krasnoyarsk
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Investigator Site - Site #3213
Kursk
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Investigator Site - Site #3208
Pushkin
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Investigator Site - Site #3235
390011 Ryazan'
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Investigator Site - Site #3231
191758 Saint Petersburg
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Investigator Site - Site #3206
Saint Petersburg
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Investigator Site - Site #3215
Yaroslavl
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Investigator Site - Site #2248
15006 A Coruña
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Investigator Site - Site #2249
08911 Badalona
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Investigator Site - Site #2245
08025 Barcelona
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Investigator Site - Site #2244
08028 Barcelona
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Investigator Site - Site #2252
08035 Barcelona
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Investigator Site - Site #2246
14004 Córdoba
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Investigator Site - Site #2247
08904 L'Hospitalet De Llobregat
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Investigator Site - Site #2238
29789 Málaga
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Investigator Site - SIte #2223
41009 Sevilla
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Alle anzeigen

Studien-Informationen

Detailed Description:

The main purpose of this study is to compare the efficacy, as measured by recurrence-free

survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus

nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN]

metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC]

8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for

recurrence.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Male or female patients, age 12 years or older at the time of signing the informed

consent form (age 18 years or older where local regulations or institutional policies

do not allow for patients < 18 years of age to participate).

- Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV

(M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been

completely surgically resected within 12 weeks prior to randomization.

- Tumor tissue from biopsy or resected disease must be provided to central laboratory

for PD-L1 status analysis. Must have PD-L1 expression classification for

stratification purposes.

- Disease-free status documented by a complete physical examination and imaging studies

within 28 days prior to randomization.

Exclusion Criteria:

- History of ocular/uveal melanoma or mucosal melanoma.

- Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus,

hypothyroidism only requiring hormone replacement, skin disorders not requiring

systemic treatment, or conditions not expected to recur in the absence of an external

trigger are permitted to enroll.

- Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily

prednisone equivalent) or other immunosuppressive medications within 14 days of

randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10

mg daily prednisone equivalent, are permitted in the absence of active autoimmune

disease.

- Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant

radiation therapy for central nervous system lesions.

- Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2

(IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or

anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any

other antibody or drug specifically targeting T cell co-stimulation or checkpoint

pathways).

- Prior malignancy active within the previous 3 years except for locally curable cancers

that have been apparently cured.

Studien-Rationale

Primary outcome:

1. RFS of bempegaldesleukin plus nivolumab versus nivolumab alone by BICR, is defined as the time between date of randomization and date of first recurrence, new primary melanoma, or all-cause death (Time Frame - Approximately up to 60 months)



Secondary outcome:

1. Overall Survival (OS) defined as the time between the date of randomization and the date of death due to any cause (Time Frame - Approximately up to 83 months)

2. Distant Metastasis Free Survival is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first, will be evaluated in patients who are Stage III at study entry (Time Frame - Approximately up to 60 months)

3. Overall safety and tolerability of bempegaldesleukin plus nivolumab will be measured by the incidence of AEs, SAEs, deaths, and laboratory abnormalities using CTCAE Version 5.0 criteria (Time Frame - Approximately up to 60 months)

4. Patient Reported Outcomes will be measured by changes from baseline in scores for the global health/quality of life and physical functioning subscales of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (Time Frame - Approximately up to 60 months)

5. The predictive strength of PD-L1 expression as a biomarker will be measured by the endpoint RFS by BICR based on PD-L1 expression level (Time Frame - Approximately up to 60 months)

6. RFS by Investigator will be measured similarly to the primary endpoint, but recurrence and new primary melanoma will be decided by the Investigator (Time Frame - Approximately up to 60 months)

Studien-Arme

  • Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab
    Arm A: Participants will receive bempegaldesleukin (NKTR-214) 0.006mg/kg IV in combination with nivolumab 360mg every 3 weeks.
  • Active Comparator: Nivolumab
    Arm B: Participants will receive nivolumab 480mg IV alone every 4 weeks.

Geprüfte Regime

  • Bempegaldesleukin (NKTR-214 / BMS-986321 / ):
    Specified dose on specified days
  • Nivolumab (Opdivo® / BMS-936558 / ):
    Specified dose on specified days

Quelle: ClinicalTrials.gov


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