Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Diese Studie soll herausfinden, ob eine Kombinationsimmuntherapie mit Nivolumab und Ipilimumab bei Patienten mit fortgeschrittenem Nierenkrebs, welcher nicht operabel ist oder Ableger gebildet hat, eine Wirkung hat, d.h. einen Stillstand oder sogar Rückgang des Krebses bewirken kann. Nivolumab und Ipilimumab sind schon als Einzelmedikamente für die Behandlung von Nierenkrebs zugelassen. Die Kombinationstherapie ist bereits für die Behandlung von schwarzem Hautkrebs zugelassen. 74 Patienten werden in die Studie eingeschlossen. Die Behandlung dauert je nach Wirkung bis zu 2 Jahre.
Zudem soll in der Studie untersucht werden, welche Faktoren eine Rolle spielen, ob ein Patient auf die Medikamente anspricht. Zu diesem Zweck werden neben der Behandlung auch Blutproben und Gewebeproben entnommen (mindestens 2 Gewebeproben).
Malattie studiate(Fonte di dati: BASEC)
Nierenkrebs
Health conditions
(Fonte di dati: WHO)
Renal Cell Carcinoma
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Alle Patienten erhalten die gleichen Medikamente. Wer an dieser Studie teilnimmt, wird eine Behandlung mit Nivolumab erhalten, welche alle 2 Wochen intravenös verabreicht wird. Nach den ersten 2 Wochen wird zusätzlich mit dem Medikament Ipilimumab begonnen. Es finden alle 6-8 Wochen Computertomographien (Röntgenbilder) statt. Wenn der Tumor schrumpft, wird das Medikament Ipilimumab im Verlauf gestoppt und nur noch das Nivolumab weitergeführt.
Die Entnahme von Gewebsproben (Biopsien) vor Beginn der Medikamente, nach 12-16 Wochen und bei Ende der Studie sind ein wichtiger Bestandteil der Studie, um herauszufinden, warum die Medikamente wirken.
Interventions
(Fonte di dati: WHO)
Drug: nivolumab;Drug: ipilimumab
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Personen über 18 Jahre, die an fortgeschrittenem Nierenkrebs leiden, und bei denen der Tumor durch eine Operation nicht komplett entfernt werden kann oder falls sich bereits Ableger gebildet haben. Patienten, die noch keine oder eine Medikamentherapie gegen den Nierenkrebs erhalten haben, können an der Studie teilnehmen.
Criteri di esclusione
(Fonte di dati: BASEC)
Patienten mit auto-immune Krankheiten (z.B. rheumatoide Arthritis, multiple Sklerose etc.).
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Written informed consent according to Swiss law and ICH/GCP regulations before
registration and prior to any trial specific procedures
- Histologically or cytologically confirmed, locally advanced and/or metastatic clear
cell RCC not amenable to surgery or definitive radiotherapy, and requiring systemic
therapy
- Patient able and willing to provide serial biopsies and blood drawings (initial, at 14
weeks (except for patient in the expansion cohort), and at progression).
- Measurable disease
- In case of second line patients, the previous therapy must be stopped at least 2 weeks
prior to registration
- Age = 18 years
- WHO performance status of 0-1
- Bone marrow function: neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L
- Hepatic function: total bilirubin = 1.5 x ULN (except for patients with Gilbert's
disease = 3.0 x ULN), AST, ALT and AP = 2.5 x ULN (= 5 x ULN if significant hepatic
metastasis is suspected to be the cause for enzyme elevation)
- Renal function: eGFR > 20 mL/min/1.732
- Cardiac function: NYHA = 2. In case of cardiac insufficiency NYHA 1 or 2, Left
ventricular Ejection Fraction (LVEF) = 35% as determined by echocardiography (ECHO) or
multigated acquisition (MUGA) scan
- Women with child-bearing potential are using effective contraception are not pregnant
or lactating and agree not to become pregnant during trial treatment and during 5
months thereafter. A negative pregnancy test before inclusion into the trial is
required for all women with child-bearing potential.
- Men agree not to father a child during trial treatment and during 5 months thereafter
Exclusion Criteria:
- Uncontrolled CNS metastases. Patients with asymptomatic CNS metastases (at least 2
weeks after radiotherapy or surgery and steroids with prednisone equivalent of 10 mg
or lower) are eligible
- History of hematologic or primary solid tumor malignancy, unless in remission for at
least 3 years from registration with the exception of pT1-2 prostate cancer Gleason
score < 6, adequately treated cervical carcinoma in situ, or localized non-melanoma
skin cancer.
- More than one previous line of systemic therapy for mRCC
- Prior immunotherapy.
- Concurrent or recent (within 30 days of registration) treatment with any other
experimental drug
- Concomitant use of other anti-cancer drugs or radiotherapy except for local pain
control (radiotherapy of target lesion not allowed)
- Immunosuppressive medications (such as but not limited to: methotrexate, azathioprine,
and TNF-a blockers) within 30 days before registration
Exception:
- systemic corticosteroids at doses not exceeding 10 mg/day of prednisone or equivalent
- immunosuppressive medications for patients with contrast allergies
- inhaled and intranasal corticosteroids
- Live attenuated vaccination within 30 days prior to registration and for 30 days after
last dose of any of the trial drugs. Inactivated viruses, such as those in the
influenza vaccine, are permitted
- History of or active auto-immune disease with the exception of diabetes mellitus type
II
- Human immunodeficiency virus (HIV) infection or active chronic Hepatitis C or
Hepatitis B Virus infection or any uncontrolled active systemic infection requiring
intravenous (iv) antimicrobial treatment
- Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, treatment and follow-up, affect patient compliance or place the
patient at high risk from treatment-related complications.
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
Nivolumab in Combination With Ipilimumab in Patients With Metastatic Renal Cell Carcinoma: A Multicenter Single-arm Phase lI Trial
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 2
Punti finali primari
(Fonte di dati: WHO)
Overall response rate (ORR)
Punti finali secondari
(Fonte di dati: WHO)
Progression-free survival (PFS);Duration of response (DOR);Time to treatment failure (TTF);Overall survival (OS);Adverse events (AEs)
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Aarau, Baden, Basilea, Berna, Chur, Friburgo, Ginevra, Losanna, San Gallo, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Gilles Godar
+41 31 389 91 91
trials@sakk.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Frank Stenner, Prof;Heinz L?ubli, MD
Universit?tsspital Basel
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Frank Stenner, Prof;Heinz L?ubli, MD
Universit?tsspital Basel
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Data di autorizzazione da parte della commissione d’etica
22.11.2017
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2017-01595
Secondary ID (Fonte di dati: WHO)
SAKK 07/17
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