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JOURNAL ONKOLOGIE – STUDIE

A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT05805501

Studienbeginn:
April 2023

Letztes Update:
11.04.2024

Wirkstoff:
Tiragolumab, Pembrolizumab, Axitinib, Tobemstomig

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-LaRoche

Kontakt

Reference Study ID Number: BO43936 https://forpatients.roche.com/
Kontakt:
Phone: 888-662-6728
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen

Studienlocations
(3 von 57)

Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
81675 München
(Bayern)
GermanyRekrutierend» Google-Maps
Studienpraxis Urologie
72622 Nürtingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Tübingen; Klinik für Urologie
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Ulm; Klinik für Urologie
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
University of Alabama at Birmingham; Comprehensive Cancer Center
35294-3300 Birmingham
United StatesRekrutierend» Google-Maps
UC Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-Maps
Sibley Memorial Hospital
20016 Washington
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - Fort Myers (Broadway)
33901 Fort Myers
United StatesRekrutierend» Google-Maps
EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center
30322 Atlanta
United StatesRekrutierend» Google-Maps
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
21287 Baltimore
United StatesRekrutierend» Google-Maps
Greco-Hainesworth Centers for Research; ETN (East Tennessee)
37404 Chattanooga
United StatesRekrutierend» Google-Maps
Thompson Cancer Survival Center
37916-2305 Knoxville
United StatesRekrutierend» Google-Maps
Tennessee Oncology - Nashville
37203 Nashville
United StatesRekrutierend» Google-Maps
Vanderbilt University Medical Center; Vanderbilt University
37232 Nashville
United StatesRekrutierend» Google-Maps
Sunshine Coast University Hospital; The Adem Crosby Centre
4575 Birtinya
AustraliaRekrutierend» Google-Maps
ICON Cancer Care Adelaide
5037 Kurralta Park
AustraliaRekrutierend» Google-Maps
Peking University First Hospital
100034 Beijing City
ChinaAktiv, nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaAktiv, nicht rekrutierend» Google-Maps
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
210008 Nanjing City
ChinaAktiv, nicht rekrutierend» Google-Maps
Tianjin Cancer Hospital
300060 Tianjin
ChinaAktiv, nicht rekrutierend» Google-Maps
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Institut Sainte Catherine;Recherche Clinique
84918 Avignon
FranceRekrutierend» Google-Maps
CHU Besançon - Hôpital Jean Minjoz
25030 Besançon Cedex
FranceRekrutierend» Google-Maps
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
33075 Bordeaux
FranceRekrutierend» Google-Maps
Centre Francois Baclesse; Oncologie
14076 Caen
FranceRekrutierend» Google-Maps
Centre Leon Berard; Departement Oncologie Medicale
69373 Lyon
FranceRekrutierend» Google-Maps
Institut Gustave Roussy; Oncologie Medicale
94800 Villejuif
FranceRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Jeollanam-do
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
36-200 Brzozów
PolandAbgeschlossen» Google-Maps
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
30-688 Kraków
PolandAktiv, nicht rekrutierend» Google-Maps
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
20-090 Lublin
PolandRekrutierend» Google-Maps
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
60-569 Pozna?
PolandAktiv, nicht rekrutierend» Google-Maps
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
04-073 Warszawa
PolandRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron; Oncology
08035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal;Oncology Dept.
28034 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre; Servicio de Oncologia
28041 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
41013 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe; Oncologia
46026 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
East Lancashire Hospitals NHS Trust
BB10 2PQ Burnley
United KingdomZurückgezogen» Google-Maps
Colchester General Hospital
CO4 5JL Colchester, Essex
United KingdomZurückgezogen» Google-Maps
Medway Maritime Hospital
ME7 5NY Gillingham
United KingdomZurückgezogen» Google-Maps
Barts & London School of Med; Medical Oncology
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital; Dept of Med-Onc
SW3 6JJ London
United KingdomZurückgezogen» Google-Maps
Christie Hospital Nhs Trust; Medical Oncology
M2O 4BX Manchester
United KingdomRekrutierend» Google-Maps
Nottingham City Hospital; Oncology
NG5 1PB Nottingham
United KingdomRekrutierend» Google-Maps
Plymouth Oncology Centre; Clinical Trials Unit
PL6 8DH Plymouth
United KingdomZurückgezogen» Google-Maps
Royal Marsden Hospital; Institute of Cancer Research
SM2 5PT Sutton
United KingdomZurückgezogen» Google-Maps
Singleton Hospital; Cancer Institute
SA2 8QA Swansea
United KingdomZurückgezogen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also

known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and

axitinib, as compared to pembrolizumab and axitinib in participants with previously

untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma

(ccRCC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

- International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1

or 2) or poor (score of 3-6)

- Measurable disease with at least one measurable lesion

- Histologically confirmed ccRCC with or without sarcomatoid features

- Negative for HIV, hepatitis B, or hepatitis C virus (HCV)

Exclusion Criteria:

- Pregnant or breastfeeding, or intention of becoming pregnant during the study or

within 90 days after the final dose of tiragolumab, 4 months after the final dose of

tobemstomig (RO7249669) and pembrolizumab, or for 1 week after the final dose of

axitinib, whichever occurs last

- Inability to swallow a tablet or malabsorption syndrome

- Prior treatment for localized and/or metastatic RCC with systemic RCC-directed

therapy, including T-cell costimulating or immune checkpoint blockade therapies

- Ongoing use or anticipated need for treatment with a strong CYP3A4/5 inhibitor or

inducer

- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation

of study treatment, or anticipation of need for a major surgical procedure during the

study

- Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring

continued use of bisphosphonate therapy or denosumab

- Symptomatic, untreated, or actively progressing central nervous system (CNS)

metastases

- History of leptomeningeal disease

- Uncontrolled tumor-related pain

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent

drainage procedures (once monthly or more frequently)

- Moderate to severe hepatic impairment (Child-Pugh B or C)

- Uncontrolled hypertension

- Prior history of hypertensive crisis or hypertensive encephalopathy

- Significant cardiovascular/cerebrovascular disease within 3 months prior to

randomization

- History of clinically significant ventricular dysrhythmias or risk factors for

ventricular dysrhythmias

- History of congenital QT syndrome

- Resting heart rate (HR) > 100 bpm (or clinically significant tachycardia)

- Stroke (including transient ischemic attack), myocardial infarction, or other

symptomatic ischemic event, or thromboembolic event (e.g., deep venous thrombosis

[DVT], pulmonary embolism [PE]) within 3 months before randomization

- Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring

surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day

1 of Cycle 1

- Tumors invading pulmonary blood vessels, cavitating pulmonary lesions or known

endobronchial disease

- Tumor invading the gastrointestinal (GI) tract, including abdominal or

tracheoesophageal fistulas

- Evidence of abdominal free air not explained by paracentesis or recent surgical

procedure

- Active peptic ulcer disease, acute pancreatitis, acute obstruction of the pancreatic

or biliary duct, appendicitis, cholangitis, cholecystitis, diverticulitis, gastric

outlet obstruction

- Intra-abdominal abscess within 6 months before initiation of study treatment

- Clinical signs or symptoms of GI obstruction or requirement for routine parenteral

hydration, parenteral nutrition, or tube feeding

- Evidence of bleeding diathesis or significant coagulopathy

- Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study

treatment

- Clinically significant hematuria, hematemesis, hemoptysis of > 0.5 teaspoon (2.5 mL)

of red blood, coagulopathy, or other history of significant bleeding (e.g., pulmonary

hemorrhage) within 3 months before initiation of study treatment

- Active or history of autoimmune disease or immune deficiency

- Treatment with systemic immunosuppressive medication within 2 weeks prior to

initiation of study treatment, or anticipation of need for systemic immunosuppressive

medication during study treatment

- Prior allogeneic stem cell or solid organ transplantation

- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis

obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of

active pneumonitis on screening chest computed tomography (CT) scan

- History of another primary malignancy other than RCC within 2 years prior to

screening, with the exception of malignancies with a negligible risk of metastasis or

death (e.g., 5-year OS rate > 90%)

- Administration of a live, attenuated vaccine within 4 weeks before randomization or

anticipation that such a live, attenuated vaccine will be required during the study

- Active tuberculosis (TB)

- Severe infection within 4 weeks prior to initiation of study treatment

- Participants with active Epstein-Barr virus (EBV) infection or known or suspected

chronic active EBV infection at screening

- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation

of study treatment

- Known hypersensitivity to Chinese hamster *ovary cell products or to any component of

tobemstomig, tiragolumab, pembrolizumab, or axitinib

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days))



Secondary outcome:

1. Overall Survival (OS) (Time Frame - From randomization to death from any cause (up to 35 treatment cycles; cycle length = 21 days))

2. Confirmed Objective Response Rate (ORR) (Time Frame - Up to 35 treatment cycles (cycle length = 21 days))

3. Duration of Response (DoR) (Time Frame - From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 35 treatment cycles; cycle length = 21 days))

Studien-Arme

  • Experimental: Arm A (Tobemstomig + Axitinib)
    Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).
  • Experimental: Arm B (Tobemstomig + Tiragolumab + Axitinib)
    Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.
  • Active Comparator: Control Arm (Pembrolizumab + Axitinib)
    Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.

Geprüfte Regime

  • Tobemstomig (RO7247669):
    Participants will receive IV tobemstomig Q3W.
  • Tiragolumab:
    Participants will receive IV tiragolumab Q3W.
  • Pembrolizumab (Keytruda):
    Participants will receive IV pembrolizumab Q3W.
  • Axitinib (Inlyta):
    Participants will receive axitinib PO BID.

Quelle: ClinicalTrials.gov


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