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SNCTP000004172 | EUCTR2020-000349-14 | BASEC2020-01797
Alternative entry: NCT12345678

Studie zur Untersuchung von NIS793 (mit oder ohne Spartalizumab) in Kombination mit Chemotherapie bei Patienten mit metastasiertem Bauchspeicheldrüsenkrebs

Data source: BASEC (Imported from 19.10.2021), WHO (Imported from 18.04.2021)
Changed: 14.10.2021
Disease category: Pancreatic Cancer

Brief description of trial (Data source: BASEC)

Ziel dieser Studie ist es, herauszufinden, ob das Medikament NIS793 mit oder ohne Spartalizumab in Kombination mit einer Standard-Chemotherapie (Gemcitabin und nab-Paclitaxel) bei Patienten mit metastasiertem Bauchspeicheldrüsenkrebs sicher und wirksam ist.
NIS793 und Spartalizumab sind vom Schweizerischen Heilmittelinstitut Swissmedic und anderen Gesundheitsbehörden für die Behandlung von Menschen mit Bauchspeicheldrüsenkrebs noch nicht zugelassen.
Gemcitabin und nab-Paclitaxel sind Chemotherapeutika. Sie sind von Swissmedic und anderen Gesundheitsbehörden für die Behandlung von verschiedenen Arten von Krebs, darunter auch Bauchspeicheldrüsenkrebs, zugelassen.
Diese Studie besteht aus zwei Teilen:
Teil 1: In diesem Teil der Studie wird eine kleine Anzahl von Patienten (ca. 6) NIS793 mit Spartalizumab in Kombination mit einer Standard-Chemotherapie (Gemcitabin und nab-Paclitaxel) erhalten. Der Zweck dieses Teils besteht darin, herauszufinden, ob die Studienbehandlung sicher ist.
Teil 2: Wenn sich die Studienbehandlung in Teil 1 der Studie als sicher erwiesen hat, beginnt Teil 2 der Studie. In diesem Teil der Studie werden die Patienten chancengleich einem der drei Behandlungsarme zugeteilt:
• Arm 1: NIS793 + Spartalizumab + Gemcitabin + nab-Paclitaxel
• Arm 2: NIS793 + Gemcitabin + nab-Paclitaxel
• Arm 3: Gemcitabin + nab-Paclitaxel
Rund 156 Patienten werden in verschiedenen Studienzentren rund um die Welt an der Studie teilnehmen, davon ungefähr 10 in der Schweiz.

Health conditions investigated (Data source: BASEC)

Metastasierter Bauchspeicheldrüsenkrebs

Health conditions (Data source: WHO)

Pancreatic ductal adenocarcinoma;Therapeutic area: Diseases [C] - Cancer [C04]

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Alle Studienmedikamente werden als Infusionen in eine Vene verabreicht:
• Gemcitabin und nab-Paclitaxel an den Tagen 1, 8 und 15 jedes 28-tägigen Zyklus
• NIS793 an den Tagen 1 und 15 jedes 28-tägigen Zyklus
• Spartalizumab am Tag 1 jedes 28-tägigen Zyklus

Interventions (Data source: WHO)


Product Name: NIS793
Product Code: [NIS793]
Pharmaceutical Form: Concentrate for solution for injection/infusion
Current Sponsor code: NIS793
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Product Name: Spartalizumab
Product Code: [PDR001]
Pharmaceutical Form: Concentrate for solution for injection/infusion
Current Sponsor code: PDR001
Other descriptive name: Spartalizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: ABRAXANE - 5 MG/ML - POLVERE PER SOSPENSIONE PER INFUSIONE - USO ENDOVENOSO- 100 MG - FLACONCINO(VETRO) 1 FLACONCINO
Product Name: nab-paclitaxel
Product Code: [NA]
Pharmaceutical Form: Concentrate for solution for injection/infusion
CAS Number: 33069-62-4
Current Sponsor code: Paclitaxel
Other descriptive name: PACLITAXEL ALBUMIN-BOUND
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Product Name: gemcitabine
Product Code: [gemcitabine]
Pharmaceutical Form: Concentrate for solution for injection/infusion
CAS Number: 95058-81-4
Current Sponsor code: gemcitabine
Other descriptive name: gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Criteria for participation in trial (Data source: BASEC)

- Männliche oder weibliche Patienten ab 18 Jahre
- Patienten mit metastasiertem Bauchspeicheldrüsenkrebs, die noch keine Therapie für Ihre Erkrankung erhalten haben

Exclusion criteria (Data source: BASEC)

- Patienten, die (unkontrolierte) Hirnmetastasen haben

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
Participants with histologically or cytologically confirmed treatment naïve metastatic adenocarcinoma of the pancreas with measurable disease per RECIST 1.1.
Participants must have a site of disease amenable to biopsy, be candidate for tumor biopsy, and must be willing to undergo a tumor biopsy at screening and during therapy on the study.
ECOG performance status = 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion criteria:
Previous radiotherapy, surgery (note: placement of biliary stent is allowed), chemotherapy or investigational therapy for the treatment of metastatic disease. Participants having received previous chemotherapy in the adjuvant setting
Participants with MSI-H pancreatic adenocarcinoma
Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors
Participants amenable to potentially curative resection
Presence of symptomatic CNS metastases or CNS metastases that require local CNS-directed therapy
History of severe hypersensitivity reactions to other monoclonal antibodies
Malignant disease other than that being treated in the study
Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) or any immunosuppressive therapy
Known history of testing positive for HIV infection
Active HBV and HCV infection
Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
Active, known or suspected autoimmune disease
History of or current pneumonitis or interstitial lung disease

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-000349-14

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2020-000349-14-IT

Further information on trial

Date trial registered

22.10.2020

Incorporation of the first participant

08.10.2020

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

A phase II, open label, randomized, parallel arm study of NIS793 (with and without spartalizumab) in combination with SOC chemotherapy gemcitabine/nab-paclitaxel, and gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) - NA

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: NA
Number of treatment arms in the trial: 4

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: Safety Run-in part:
• To assess the safety and tolerability of NIS793 with spartalizumab in combination with gemcitabine/nab-paclitaxel.

Randomized part:
• To evaluate the Progression Free Survival (PFS) per Investigator assessment of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus SOC chemotherapy gemcitabine/nab-paclitaxel.
• To evaluate the PFS of NIS793 with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
;Secondary Objective: Randomized part:
• To evaluate the safety and tolerability of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
• To assess the preliminary anti-tumor activity of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
• To assess Overall Survival (OS) of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel
• To assess the CD8 and PD-L1 status of the participants at screening and on treatment versus gemcitabine/nab-paclitaxel
• To characterize the incidence of immunogenicity of NIS793 and spartalizumab in combination with gemcitabine/nab-paclitaxel
• To characterize the pharmacokinetics (PK) of NIS793, spartalizumab, gemcitabine/nab-paclitaxel in combination treatment or alone (gemcitabine/nab-paclitaxel)
;Primary end point(s): Safety Run-in part:
1) Incidence of DLTs during the first 4 weeks of treatment
2) Safety: Incidence and severity of treatment emergent AEs and SAEs, changes between baseline and post-baseline laboratory parameters, vital signs, and ECG parameters
3) Tolerability: Dose interruptions, reductions and dose intensity
Randomized part:
4) Progression-free survival based on Response Evaluation Criteria in Solid Tumors (RECIST1.1) as per local Investigator’s review;Timepoint(s) of evaluation of this end point: 1) DLT observation period 4 weeks
2), 3), 4) end of study

Secundary end point (Data source: WHO)

Secondary end point(s): Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and ECGs, dose interruptions, reductions, and dose intensity
Overall response rate (ORR), Duration of response (DOR), Time to Progression (TTP) RECIST 1.1 as per local Investigator’s review
Overall Survival (OS)
Change from baseline in CD8 and PD-L1 IHC related markers
Antidrug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment (anti-NIS793 and anti-spartalizumab)
Pharmacokinetic parameters (e.g. Ctrough, Cmax, AUClast)
PK concentration time profiles
;Timepoint(s) of evaluation of this end point: as per protocol Table 8-1

Contact information (Data source: WHO)

Novartis Pharma AG

Trial results (Data source: WHO)

Results summary

A phase II, open label, randomized, parallel arm study of NIS793 (with and without spartalizumab) in combination with SOC chemotherapy gemcitabine/nab-paclitaxel, and gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

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, Zurich

Countries (Data source: WHO)

Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Japan, Singapore, Spain, Switzerland, Taiwan, United Kingdom, 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)

Regulatory Affairs
Largo Umberto Boccioni, 1
Novartis Farma
029659066
info.studiclinici@novartis.com

Contact for scientific information (Data source: WHO)

Regulatory Affairs
Largo Umberto Boccioni, 1
Novartis Farma
029659066
info.studiclinici@novartis.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

NOVARTIS PHARMA AG

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

18.09.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-01797

Secondary ID (Data source: WHO)

CNIS793B12201
ISRCTN12345678
NCT12345678
2020-000349-14-FI