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NCT02947165 | SNCTP000003442

Studie zur Untersuchung von NIS793 in Kombination mit PDR001 bei erwachsenen Patienten mit fortgeschrittenen Tumoren

Data source: BASEC (Imported from 25.02.2020), WHO (Imported from 23.02.2020)
Changed: 16.02.2020
Disease category: Lungenkrebs, Brustkrebs, Nierenkrebs, Dickdarm- und Mastdarmkrebs, Bauchspeicheldrüsenkrebs, Anderer Krebs

Brief description of trial (Source of data: 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 (Source of data: BASEC)

Fortgeschrittene Tumore wie nichtkleinzelliger Lungenkrebs, Brustkrebs, Leberzellkarzinom, Kolorektalkarzinom, Bauchspeicheldrüsenkrebs oder Nierenzellkarzinom

Health conditions (Source of data: WHO)

Breast Cancer;Lung Cancer;Hepatocellular Cancer;Colorectal Cancer;Pancreatic Cancer;Renal Cancer

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: 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 (Source of data: WHO)

Drug: NIS793;Drug: PDR001

Criteria for participation in trial (Source of data: BASEC)

- Männliche oder weibliche Patienten ab 18 Jahre
- Patienten mit fortgeschrittenen Tumoren wie nichtkleinzelliger Lungenkrebs, Brustkrebs, Leberzellkarzinom, Kolorektalkarzinom, Bauchspeicheldrüsenkrebs oder Nierenzellkarzinom

Exclusion criteria (Source of data: BASEC)

- Patienten, die Hirnmetastasen haben
- Patienten mit einer Autoimmunerkrankung

Inclusion/Exclusion Criteria (Source of data: 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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02947165

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02947165

Further information on trial

Date trial registered

18.10.2016

Incorporation of the first participant

25.04.2017

Recruitment status

Recruiting

Academic title (Source of data: 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 (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Source of data: WHO)

Phase 1

Primary end point (Source of data: 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 (Source of data: WHO)

Characterization of tumor infiltrating lymphocytes by immunohistochemistry using markers such as CD8 and PD-L1;Characterization of tumor infiltrating lymphocytes (TILs) by H&E;Half life of NIS793 as single agent and in combination with PDR001.;Tmax for NIS793 single agent and NIS793 in combination with PDR001.;Cmax for NIS793 single agent and NIS793 in combination with PDR001.;Area under the curve (AUC) for NIS793 single agent and NIS793 in combination with PDR001.;Concentration of anti-NIS793 and anti-PDR001 antibodies;Presence of anti-NIS793 and anti-PDR001 antibodies;Serum concentration-time profiles of NIS793 single agent and NIS793 in combination with PDR001;Duration of response (DOR);Progression free survival (PFS);Overall response rate (ORR);Disease control rate (DCR);Best overall response (BOR)

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

St Gallen

Countries (Source of data: WHO)

Austria, Canada, Germany, Hong Kong, Italy, Japan, Switzerland, Taiwan, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Patrick Grabher
+41 79 330 70 18
patrick.grabher@novartis.com

Contact for general information (Source of data: WHO)

Novartis Pharmaceuticals
Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@novartis.com

Contact for scientific information (Source of data: WHO)

Novartis Pharmaceuticals
Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@novartis.com

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Novartis Pharmaceuticals

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-01157

Secondary ID (Source of data: WHO)

2016-003044-36;CNIS793X2101