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JOURNAL ONKOLOGIE – STUDIE
STELLAR-304

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT05678673

Studienbeginn:
Januar 2023

Letztes Update:
12.01.2024

Wirkstoff:
XL092, Nivolumab, Sunitinib Malate

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Renal Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Exelixis

Collaborator:
-

Kontakt

Studienlocations
(3 von 87)

Exelixis Clinical Site #79
06295 Lutherstadt Eisleben
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Exelixis Clinical Site #1
91010 Duarte
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #55
32209 Jacksonville
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #58
10029 New York
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #15
10065 New York
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #42
44106 Cleveland
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #2
37916 Knoxville
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #31
75246 Dallas
United StatesRekrutierend» Google-Maps
Exelixis Clinical Site #44
B7600FZO Buenos Aires
ArgentinaRekrutierend» Google-Maps
Exelixis Clinical Site #35
C1419GEP Caba
ArgentinaRekrutierend» Google-Maps
Exelixis Clinical Site #51
2000 Santa Fe
ArgentinaRekrutierend» Google-Maps
Exelixis Clinical Site #14
4032 Chermside
AustraliaRekrutierend» Google-Maps
Exelixis Clinical Site #29
4101 South Brisbane
AustraliaRekrutierend» Google-Maps
Exelixis Clinical Site #68
14784 400 Barretos
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #39
88301-220 Itajaí
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #69
99010-090 Passo Fundo
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #70
90110-270 Porto Alegre
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #78
91350-200 Porto Alegre
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #87
09060-870 Santo André
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #43
17210-120 Sao Paulo
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #50
15090-000 São José Do Rio Preto
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #81
01323-001 São Paulo
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #85
01323-903 São Paulo
BrazilRekrutierend» Google-Maps
Exelixis Clinical Site #53
7520378 Providencia
ChileRekrutierend» Google-Maps
Exelixis Clinical Site #74
14076 Caen Cedex
FranceRekrutierend» Google-Maps
Exelixis Clinical Site #66
63011 Clermont-Ferrand
FranceRekrutierend» Google-Maps
Exelixis Clinical Site #67
75475 Paris Cedex
FranceRekrutierend» Google-Maps
Exelixis Clinical Site #76
69310 Pierre-Bénite
FranceRekrutierend» Google-Maps
Exelixis Clinical Site #59
51726 Reims cedex
FranceRekrutierend» Google-Maps
Exelixis Clinical Site #41
67200 Strasbourg
FranceRekrutierend» Google-Maps
Exelixis Clinical Site #48
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps
Exelixis Clinical Site #72
71013 San Giovanni Rotondo
ItalyRekrutierend» Google-Maps
Exelixis Clinical Site #11
49201 Busan
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #32
49267 Busan
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #22
42601 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #13
35015 Daejeon
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #16
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #25
16247 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #21
13496 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #5
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #10
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #4
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #47
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #6
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #20
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Exelixis Clinical Site #54
50586 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Exelixis Clinical Site #24
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Exelixis Clinical Site #46
62250 Putrajaya
MalaysiaRekrutierend» Google-Maps
Exelixis Clinical Site #64
631BM Eindhoven
NetherlandsRekrutierend» Google-Maps
Exelixis Clinical Site #45
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Exelixis Clinical Site #82
50200 Chiang Mai
ThailandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in

combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced

or metastatic nccRCC who have not received prior systemic anticancer therapy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed nccRCC that is unresectable, advanced or metastatic.

Histologic subtypes including papillary, unclassified, and translocation-associated

are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed.

- Measurable disease according to RECIST v1.1 as determined by the Investigator.

- Available archival tumor biopsy material.

- Recovery to baseline or ≤ Grade 1 per CTCAE v5 from AE(s) related to any prior

treatments unless AE(s) are deemed clinically nonsignificant by the Investigator

and/or stable on supportive therapy.

- Age 18 years or older on the day of consent.

- Karnofsky Performance Status (KPS) ≥ 70%.

- Adequate organ and marrow function within 14 days prior to randomization.

- Sexually active fertile subjects and their partners must agree to use highly effective

methods of contraception.

- Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

- Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes

of nccRCC.

- Prior systemic anticancer therapy for unresectable locally advanced or metastatic

nccRCC including investigational agents.

- Note: One prior systemic adjuvant therapy, including immune checkpoint inhibitor

therapy and excluding sunitinib, is allowed for completely resected RCC and if

recurrence occurred at least 6 months after the last dose of adjuvant therapy.

- Radiation therapy for bone metastases within 2 weeks, any other radiation therapy

within 4 weeks prior to randomization.

- Known brain metastases or cranial epidural disease unless adequately treated with

radiotherapy (including radiosurgery) or surgically removed and stable for at least 4

weeks before randomization.

- Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Subjects

who are receiving oral anticoagulants at the time of screening must be transitioned to

LMWH prior to randomization. Subjects who require treatment with platelet inhibitors

are not eligible.

- Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks

prior to randomization. Prior laparoscopic nephrectomy within 4 weeks prior to

randomization. Minor surgery (eg, simple excision, tooth extraction) within 10 days

before randomization. Complete wound healing from major or minor surgery must have

occurred at least prior to randomization.

- Note: Fresh tumor biopsies should be performed at least 7 days before

randomization. Subjects with clinically relevant ongoing complications from prior

surgical procedures, including biopsies, are not eligible.

- Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per

electrocardiogram (ECG) within 14 days before randomization.

- Pregnant or lactating females.

- Administration of a live, attenuated vaccine within 30 days before randomization.

- Note: If feasible, approved non-live vaccines for SARS-CoV-2 should be

administered at least 2 weeks before randomization.

Studien-Rationale

Primary outcome:

1. Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC) (Time Frame - Approximately 27 months after the first subject is randomized):
Defined as the time from randomization to the earlier of either radiographic PD per RECIST 1.1 as determined by the BIRC or death from any cause

2. Objective response rate (ORR) as assessed by BIRC per RECIST 1.1 (Time Frame - Up to 24 months after the first subject is randomized):
Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 as determined by the BIRC that is confirmed at a follow-up assessment ≥ 28 days later

Secondary outcome:

1. Duration of Overall Survival (OS) (Time Frame - Approximately 46 months after the first subject is randomized):
Defined as the time from randomization to death due to any cause

Studien-Arme

  • Experimental: XL092 + Nivolumab
    Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
  • Active Comparator: Sunitinib Malate
    Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib

Geprüfte Regime

  • XL092:
    Specified doses on specified days
  • Nivolumab (Opdivo®):
    Specified doses on specified days
  • Sunitinib Malate (Sutent®):
    Specified doses on specified days

Quelle: ClinicalTrials.gov


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