Brief description of trial (Data source: BASEC)
In dieser klinischen Studie soll untersucht werden, ob die Kombinationstherapie mit NIS793 und PDR001 bei Patienten mit fortgeschrittenem bzw. metastatischem Krebs wirksam und sicher ist. NIS793 und PDR001 sind Medikamente, die das Immunsystem zur Bekämpfung des Tumors aktivieren. Sie werden als eine intravenöse Infusion verabreicht. Sie sind noch von keiner Gesundheitsbehörde der Welt zugelassen.
Die Studie besteht aus zwei Teilen: Dosissteigerung und Dosisexpansion.
• Dosissteigerung: Zu Beginn erhält eine kleine Gruppe von Patienten ausschliesslich die Studienbehandlung NIS793. Nachdem bekannt ist, welche Dosisstärken von NIS793 bei alleiniger Verabreichung verträglich sind, erhalten nachfolgende Patienten NIS793 in Kombination mit PDR001. Dieser schrittweise Ablauf wird fortgesetzt, bis die optimale Dosis von NIS793 in Kombination mit PDR001 basierend auf Nebenwirkungen und dem Anteil von NIS793 in Ihrem Blut (Pharmakokinetik) ermittelt worden ist.
• Dosisexpansion: Im zweiten Teil der Studie erhalten die Patienten die NIS793-Dosis in Kombination mit PDR001, die basierend auf dem Dosissteigerungsteil als sicher befunden worden ist. Patienten in der Schweiz werden in der Dosisexpansion teilnehmen.
Es werden weltweit etwa 220 Patienten in die Studie eingeschlossen, davon ungefähr 15 in der Schweiz.
Health conditions investigated(Data source: BASEC)
Fortgeschrittene Tumore wie nichtkleinzelliger Lungenkrebs, Brustkrebs, Leberzellkarzinom, Kolorektalkarzinom, Bauchspeicheldrüsenkrebs oder Nierenzellkarzinom
Health conditions
(Data source: WHO)
Breast Cancer;Lung Cancer;Hepatocellular Cancer;Colorectal Cancer;Pancreatic Cancer;Renal Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
NIS793 und PDR001 werden alle drei Wochen als intravenöse Infusion verabreicht (21-Tage-Zyklus). Alternativ kann NIS793 alle zwei Wochen und PDR001 alle 4 Wochen verabreicht werden («28-Tage-Zyklus).
Interventions
(Data source: WHO)
Drug: NIS793;Drug: PDR001
Criteria for participation in trial
(Data source: BASEC)
- Männliche oder weibliche Patienten ab 18 Jahre
- Patienten mit fortgeschrittenen Tumoren wie nichtkleinzelliger Lungenkrebs, Brustkrebs, Leberzellkarzinom, Kolorektalkarzinom, Bauchspeicheldrüsenkrebs oder Nierenzellkarzinom
Exclusion criteria
(Data source: BASEC)
- Patienten, die Hirnmetastasen haben
- Patienten mit einer Autoimmunerkrankung
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
1. Written informed consent must be obtained prior to any screening procedures.
2. Patient (male or female) = 18 years of age.
3. Escalation: Patients with advanced/metastatic solid tumors, with measurable or
non-measurable disease as determined by RECIST version 1.1 who have progressed despite
standard therapy or are intolerant of standard therapy, or for whom no standard
therapy exists.
4. Expansion: Patients with advanced/metastatic solid tumors, with at least one
measurable lesion as determined by RECIST version 1.1, who have progressed despite
standard therapy following their last prior therapy or are intolerant to standard
therapy and fit into one of the following groups: Group 1: NSCLC resistant to
anti-PD-1/PD-L1; Group 2: TNBC; Group 3: HCC; Group 4: MSS-CRC; Group 5: pancreatic;
Group 6 ccRCC resistant to anti-PD-1/PD-L1.
Resistance to anti-PD-1/PD-L1 therapy is defined as: Documented progressive disease
occurring while on/or within 6 months after anti-PD-1 and/or anti-PD-L1 agent (single
or combination) received as the last therapy prior to enrollment.
5. ECOG Performance Status = 2.
6. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor
biopsy. Patient must be willing to undergo a new tumor biopsy at screening, and during
therapy on this study. Exceptions may be made on a case by case basis after documented
discussion with Novartis.
Exclusion Criteria:
1. History of severe hypersensitivity reactions to study treatment ingredients or other
monoclonal antibodies and components of study drug.
2. Patients with active, known or suspected autoimmune disease. Note: Patients with
vitiligo, type I diabetes mellitus, residual hypothyroidism only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger are permitted to enroll.
3. HIV infection.
4. Active HBV or HCV infection.
Other protocol-defined inclusion/exclusion criteria may apply.
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Further information on trial
Date trial registered
Oct 18, 2016
Incorporation of the first participant
Apr 25, 2017
Recruitment status
Completed
Academic title
(Data source: WHO)
A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 1
Primary end point
(Data source: WHO)
Incidence of DLTs, AEs, SAEs and dose reductions / interruptions for NIS793;Incidence of DLTs, AEs, SAEs and dose reductions/interruptions for NIS793 in combination with PDR001
Secundary end point
(Data source: WHO)
Best overall response (BOR);Disease control rate (DCR);Overall response rate (ORR);Progression free survival (PFS);Duration of response (DOR);Serum concentration-time profiles of NIS793 single agent and NIS793 in combination with PDR001;Presence of anti-NIS793 and anti-PDR001 antibodies;Concentration of anti-NIS793 and anti-PDR001 antibodies;Area under the curve (AUC) for NIS793 single agent and NIS793 in combination with PDR001.;Cmax for NIS793 single agent and NIS793 in combination with PDR001.;Tmax for NIS793 single agent and NIS793 in combination with PDR001.;Half life of NIS793 as single agent and in combination with PDR001.;Characterization of tumor infiltrating lymphocytes (TILs) by H&E;Characterization of tumor infiltrating lymphocytes by immunohistochemistry using markers such as CD8 and PD-L1
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
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)
St. Gallen
Countries
(Data source: WHO)
Austria, Canada, Germany, Hong Kong, Italy, Japan, Switzerland, Taiwan, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Patrick Grabher
+41 79 330 70 18
patrick.grabher@novartis.com
Contact for general information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact for scientific information
(Data source: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
09.08.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01157
Secondary ID (Data source: WHO)
2016-003044-36
CNIS793X2101
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