Brief description of trial (Data source: BASEC)
Das Hauptziel dieser Studie ist der Vergleich von Nivolumab und Ipilimumab mit dem Extreme-Studienregime als Erstlinientherapie bei Patienten mit wiederkehrendem oder metastasierendem Plattenepithelkarzinom des Kopf- und Halsbereichs
Health conditions investigated(Data source: BASEC)
Wiederkehrendes oder metastasierendes Plattenepithelkarzinom des Kopf- und Halsbereichs
Health conditions
(Data source: WHO)
Head and Neck Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Medikament (Experimenteller Behandlungsarm): Nivolumab und Ipilimumab;
Medikament (Vergleichsarm): Extreme-Studienregime (Cetuximab + Cisplatin oder Carboplatin + Fluorouracil)
Interventions
(Data source: WHO)
Biological: Nivolumab;Biological: Ipilimumab;Drug: Cetuximab/Erbitux;Drug: Cisplatin/Platinol;Drug: Carboplatin/Paraplatin;Drug: Fluorouracil/Adrucil
Criteria for participation in trial
(Data source: BASEC)
- Histologisch bestätigtes wiederkehrendes oder metastasierendes Plattenepithelkarzinom des Kopf- und Halsbereichs (Mundhöhle, Oropharynx, Hypopharynx und Larynx), welches nicht auf eine kurative Therapie anspricht.
- Keine vorherige systemische Krebstherapie gegen eine rezidivierende oder metastasierende Erkrankung (mit Ausnahme die Chemotherapie war Teil einer multimodalen Behandlung, die bereits seit mindestens 6 Monaten vor Studienaufnahme beendet wurde).
- Messbare Erkrankung in einer bildgebenden Untersuchung (CT oder MRT).
- Vorhandenes Tumorgewebe für die Testung der PD-L1 Expression, und bei Krebs des Oropharynx vorhandenes Testergebnisse zum HPV p-16 Status.
Exclusion criteria
(Data source: BASEC)
- Metastasierendes oder wiederkehrendes Karzinom des Nasopharynx, Plattenepithelkarzinom mit unbekanntem Primärherd, von der Haut und der Speicheldrüse ausgehendes Plattenepithelkarzinome oder nicht-plattenepitheliale Histologien (z. B. mukosales Melanom).
- Keine vorherige Behandlung mit Anti-PD-1-, Anti-PD-L1-, Anti-CTLA-4-Antikörpern oder anderen Antikörpern oder Medikamenten, die speziell gegen die T-Zell-Kostimulation oder die Checkpoint-Signalwege gerichtet sind, oder vorherige Behandlung mit Cetuximab oder EGFR-Inhibitoren in einer beliebigen Behandlung.
- Patienten mit bestimmten Erkrankungen wie z.B. aktive Autoimmunerkrankung, Typ I Diabetes, Schilddrüsenunterfunktion, die eine Hormonersatztherapie erfordert, aktive Infektion, psychiatrische Erkrankung.
- Unzureichende hämatologische Funktion, Nieren- oder Leberfunktion.
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head
and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to
curative therapy.
- No prior systemic cancer therapy for recurrent or metastatic disease (except if
chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
- Measurable disease detected by imaging exam (CT or MRI).
- Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have
results from testing of HPV p16 status.
Exclusion Criteria:
- Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of
unknown primary, squamous cell carcinoma originating from skin and salivary glands or
non squamous histologies (eg. mucosal melanoma).
- No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other
antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab
or EGFR inhibitors in any treatment setting.
- Participants with certain diseases such as active autoimmune disease, type I diabetes,
hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
- Inadequate hematologic, renal or hepatic function.
Other protocol defined inclusion/exclusion criteria could apply
-
Further information on trial
Date trial registered
Apr 13, 2016
Incorporation of the first participant
Oct 5, 2016
Recruitment status
Completed
Academic title
(Data source: WHO)
An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Overall Survival (OS) in All Randomized Participants;Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) =20
Secundary end point
(Data source: WHO)
Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) = 1;Progression Free Survival (PFS);Objective Response Rate (ORR);Duration of Objective Response (DOR)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Zurich
Countries
(Data source: WHO)
Australia, Austria, Brazil, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Mexico, Poland, Republic of, Spain, Switzerland, Taiwan, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Dr. Dr. Sacha Rothschild
+41 61 265 50 74
sacha.rothschild@usb.ch
Contact for general information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Contact for scientific information
(Data source: WHO)
Bristol-Myers Squibb
Bristol-Myers Squibb
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
23.05.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-01360
Secondary ID (Data source: WHO)
2016-000725-39
CA209-651
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