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NCT03207867 | SNCTP000002350

Studie zu NIR178 in Kombination mit PDR001 bei Patienten mit ausgewählten fortgeschrittenen soliden Tumoren und Non-Hodgkin-Lymphom

Data source: BASEC (Imported from 19.07.2019), WHO (Imported from 07.07.2019)
Changed: 12.07.2019
Disease category: Melanom, Brustkrebs, Dickdarm- und Mastdarmkrebs, Blasenkrebs, Bauchspeicheldrüsenkrebs, Anderer Krebs, Non-Hodgkin-Lymphom

Brief description of trial (Source of data: BASEC)

In dieser klinischen Studie soll untersucht werden, ob die Kombinationstherapie mit NIR178 und PDR001 bei Patienten mit fortgeschrittenem bzw. metastatischem Krebs wirksam und sicher ist. NIR178 und PDR001 sind Medikamente, die Immunsystem zur Bekämpfung des Tumors aktivieren. PDR001 ist eine intravenöse Infusion und NIR178 sind Kapseln zum Schlucken. Sie sind noch von keiner Gesundheitsbehörde der Welt zugelassen.
In der Studie werden drei verschieden Dosierungsschemen untersucht, um das sicherste und wirksamste Dosierungsschema zu ermitteln. Es werden rund 280 Patienten weltweit teilnehmen, davon 10-15 in der Schweiz.

Health conditions investigated (Source of data: BASEC)

Fortgeschrittener Lymphom (diffuser grosszelliger B-Zell-Lymphom) oder fortgeschrittene solide Tumoren wie Nierenzellkarzinom, Bauchspreicheldrüsenkrebs, Urothelkarzinom, Kopf- und Halskarzinom, , Kolonkarzinom (mit stabilen Mikrosatelliten), Brustkrebs (dreifachnegativ), nichtkleinzelliger Lungenkrebs oder Melanom

Health conditions (Source of data: WHO)

NSCLC, Non Small Cell Lung Cancer;RCC, Renal Cell Cancer;Pancreatic Cancer;Urothelial Cancer;Head and Neck Cancer;DLBCL, Diffused Large B Cell Lymphoma;MSS, Microsatellite Stable Colon Cancer;TNBC, Triple Negative Breast Cancer

Rare disease (Source of data: BASEC)

No

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

Die Studie besteht aus drei Teilen:

Teil 1: Patienten mit ausgewählten Tumoren (s. oben) werden in diesen Teil der Studie eingeschlossen. Sie werden zweimal täglich zwei Kapseln NIR178 nehmen und erhalten alle vier Wochen eine intravenöse Infusion mit PDR001.

Teil 2: Patienten mit nichtkleinzelligem Lungenkrebs werden in diesen Teil der Studie eingeschlossen. Nach dem Zufallsprinzip werden sie einem von drei Dosierungsschema zugeteilt, um das sicherste und wirksamste Dosierungsschema zu ermitteln:
• Dosierungsschema 1: Zwei Kapseln NIR178 zweimal täglich, kontinuierlich in Kombination mit PDR001, intravenös, alle 4 Wochen.
• Dosierungsschema 2: Zwei Kapseln NIR178 zweimal täglich zwei Wochen lang, gefolgt von zwei Wochen Pause, in Kombination mit PDR001, intravenös, alle 4 Wochen.
• Dosierungsschema 3: Zwei Kapseln NIR178 zweimal täglich eine Woche lang, gefolgt von einer Woche Pause, in Kombination mit PDR001, intravenös, alle 4 Wochen.

Teil 3 wird dann gestartet, sobald die Teile 1 und 2 abgeschlossen sind und das beste Dosierungsschema fest steht. In diesem Teil werden die Sicherheit, Wirksamkeit und Immunveränderungen der Behandlung bei zwei Tumorarten je nach Ergebnissen aus Teilen 1 und 2 untersucht.

Interventions (Source of data: WHO)

Drug: NIR178

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

- Männliche oder weibliche Patienten älter als 18 Jahre
- Patienten mit diffusem grosszelligen B-Zell-Lymphom oder fortgeschrittenen soliden Tumoren wie Nierenzellkarzinom, Bauchspreicheldrüsenkrebs, Urothelkarzinom, Kopf- und Halskarzinom, , Kolonkarzinom (mit stabilen Mikrosatelliten), Brustkrebs (dreifachnegativ), nichtkleinzelliger Lungenkrebs oder Melanom

Exclusion criteria (Source of data: BASEC)

- Patienten, die Hirnmetastasen haben
- Patienten, die in letzten 2 Jahren eine Autoimmunerkrankung hatten
- Patienten, die unter einer chronisch-entzündlichen Darmerkrankung leiden

Inclusion/Exclusion Criteria (Source of data: WHO)


Inclusion Criteria:

Male or female patients =18 years of age. For Japan only: written consent is necessary both
from the patient and his/her legal representative if he/she is under the age of 20 years.

Histologically documented advanced or metastatic solid tumors or lymphomas

- Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer,
urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL),
microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC) or
melanoma

- Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those
with mixed histology, there must be a predominant histology

- Part 3: histologically confirmed diagnosis of advanced/metastatic NSCLC and one
additional tumor type based on emerging data from part 1 of the study.

Patient (except for those participating in Japanese safety run-in) must have a site of
disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating
institution's guidelines. Patient must be willing to undergo a new tumor biopsy at
screening, and again during therapy on this study.

o Part 4: Safety run-in part in Japanese patients can enroll any tumor type included in
part 1 and 2.

The collection of recent sample is permitted under the following conditions (both must be
met):

- Biopsy was collected = 3 months before 1st dose of study treatment and available at
the site.

- No immunotherapy was given to the patient since collection of biopsy.

Part 1 - 3 only: Patients (other than those with DLBCL) must previously have received at
least 1 and no more than 3 prior lines of therapy for their disease, specifically including
the following, unless considered inappropriate for the patient (e.g. safety concern, label
contraindication):

- Patients with NSCLC must have received a prior platinum-based combination.

- Patients with EGFR positive NSCLC with a T790M mutation must have progressed on
osimertinib or discontinued due to toxicity.

- Patients with head and neck cancer must have received a prior platinum-containing
regimen.

- Patients with bladder cancer must have received a prior platinum-containing regimen or
be ineligible for cisplatin.

- Patients with renal cell carcinoma must have received a prior VEGF tyrosine kinase
inhibitor (TKI).

- Patients with MSS colorectal cancer must have received (or be intolerant to) prior
therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens.

- Patients with triple negative breast cancer must have received a prior
taxane-containing regimen.

Patients with DLBCL should be limited to those with no available therapies of proven
clinical benefit

o Patients should have had prior autologous hematopoietic stem cell transplantation
(auto-HSCT) or determined to be ineligible for auto-HSCT.

Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03207867

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03207867

Further information on trial

Date trial registered

19.06.2017

Incorporation of the first participant

28.08.2017

Recruitment status

Recruiting

Academic title (Source of data: WHO)

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma

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 2

Primary end point (Source of data: WHO)

Determine the overall response rate

Secundary end point (Source of data: WHO)

Determine the disease control rate (DCR);Determine the duration of response (DoR);Determine the overall survival rate (OR);Progression free survival (PFS);Safety and tolerability of the NIR178 and PDR001 combination;Characterize changes in the immune infiltrate in tumors;Presence and/or concentration of anti-PDR001 antibodies;Pharmacokinetics: Area under plasma concentration versus time curve (AUC) (NIR178);Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) (PDR001);Plasma concentration Vs Time profiles (NIR178);Plasma concentration Vs Time profiles (PDR001);Peak plasma concentration- Cmax (NIR178);Peak plasma concentration- Cmax (PDR001);Time of maximum concentration observed- Tmax (NIR178);Time of maximum concentration observed- Tmax (PDR001)

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)

Australia, Austria, Belgium, Czechia, France, Germany, Italy, Japan, Netherlands, Singapore, Spain, Switzerland, Taiwan, United States

Contact for further information on the trial

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

Janine Woytschak
+41 79 500 93 56
janine.woytschak@novartis.com

Contact for general information (Source of data: WHO)

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

Contact for scientific information (Source of data: WHO)

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)

2017-01310

Secondary ID (Source of data: WHO)

2017-000241-49