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Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Primary Purpose

Metastatic Pancreatic Ductal Adenocarcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

NIS793

Nab-paclitaxel

Gemcitabine

Placebo

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Ductal Adenocarcinoma focused on measuring mPDAC, NIS793, Pancreas, metastatic pancreatic ductal adenocarcinoma (mPDAC), Nab-paclitaxel, Abraxane, Gemcitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Applicable for both Safety run-in and Randomized part
- Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery
- Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate organ function (assessed by central laboratory for eligibility)
- Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.

Main Exclusion Criteria:

Applicable for both Safety run-in and Randomized part
- Previous systemic anti-cancer treatment for metastatic PDAC
- Pancreatic neuroendocrine, acinar, or islet tumors
- Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).
- Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.
- Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed > 2 weeks prior to start of study treatment).
- Impaired cardiac function or clinically significant cardio-vascular disease
- Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.
- Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
- Serious non-healing wounds.
- Pregnant or breast-feeding women
- Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated
- Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Safety run-in part: NIS793+gemcitabine+nab-paclitaxel

Randomized part: NIS793+gemcitabine+nab-paclitaxel

Randomized part: placebo+gemcitabine+nab-paclitaxel

Arm Description

In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.

Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Outcomes

Primary Outcome Measures

Safety run-in part: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.

Percentage of participants with DLTs during the first cycle of treatment in the safety run-in part. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness or concomitant medication that occurs within the first cycle of treatment with NIS793 in combination with gemcitabine and nab-paclitaxel

Randomized part: Overall survival (OS)

OS is defined as the time from date of randomization to date of death due to any cause.

Secondary Outcome Measures

Percentage of participants with Adverse Events (AEs)

Percentage of participants with AEs including changes in laboratory parameters, vital signs, body weight and cardiac assessments

Percentage of participants with dose interruptions and dose reductions of NIS793 in combination with gemcitabine and nab-paclitaxel

Tolerability measured by the percentage of participants who have dose adjustments (interruptions or reductions) of NIS793

Dose intensity of NIS793 in combination with gemcitabine and nab-paclitaxel

Tolerability measured by the dose intensity of NIS793. Dose intensity will be computed as the ratio of actual cumulative dose received and actual duration of exposure

Progression-free survival (PFS) by investigator assessment per RECIST 1.1

PFS defined as the time from the date of enrollment (run-in part) or randomization (randomized part) to the date of the first documented progression based on investigator assessment and according to RECIST 1.1 or death due to any cause.

Overall response rate (ORR) by investigator assessment per RECIST 1.1

ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as per investigator assessment and according to RECIST 1.1

Disease control rate (DCR) by investigator assessment per RECIST 1.1

DCR is the proportion of participants with BOR of CR or PR or stable disease (SD) as per investigator assessment and according to RECIST 1.1

Time to response (TTR) by investigator assessment per RECIST 1.1

TTR is defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR.

Safety run-in part: Overall Survival (OS)

OS is defined as the time from the date of enrollment to date of death due to any cause.

Maximum concentration (Cmax) of NIS793 in combination with gemcitabine and nab-paclitaxel

Blood samples will be collected for analysis of Cmax of NIS793

Trough Concentration (Ctrough) of NIS793 in combination with gemcitabine and nab-paclitaxel

Blood samples will be collected for analysis of Ctrough of NIS793

Area under the curve from time zero to the last measurable concentration sampling time (AUClast) of NIS793 in combination with gemcitabine and nab-paclitaxel

Blood samples will be collected for analysis of AUClast of NIS793

Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of NIS793 in combination with gemcitabine and nab-paclitaxel

Blood samples will be collected for analysis of AUCtau of NIS793

Time to reach maximum concentration (Tmax) of NIS793 in combination with gemcitabine and nab-paclitaxel

Blood samples will be collected for analysis of Tmax of NIS793

Randomized part: NIS793 serum concentration

Blood samples will be collected for analysis of NIS793 serum concentration

Randomized part: Anti-drug antibodies (ADA) against NIS793 prevalence at baseline

ADA (anti-NIS793) prevalence at baseline is defined as the proportion of participants who have an ADA positive result at baseline

Randomized part: ADA (anti-NIS793) incidence on treatment

ADA (anti-NIS793) incidence on treatment is defined as the proportion of participants who are treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

Full Information

NCT ID

NCT04935359

First Posted

June 21, 2021

Last Updated

October 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04935359

Brief Title

Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Official Title

A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 30, 2021 (Actual)

Primary Completion Date

January 1, 2026 (Anticipated)

Study Completion Date

January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.

Detailed Description

This is a randomized, double-blind, multicenter two-arm, phase III study that has two parts: Safety run-in part: An open-label safety run-in part will be conducted to confirm recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel. Up to approximately 10 participants will be enrolled at each dose level to achieve at least 6 evaluable participants; however, if the starting dose is not recommended and a lower dose level is tested, 10 additional participants will be enrolled. The decision to open the randomized part will be based on dose confirmation and available safety, relevant PK, and other relevant data from run-in part Randomized part: Enrolled participants will be randomized to the two treatment arms. The study treatment will be administered as a 28-day treatment cycle. Participants will be treated until unacceptable toxicity, disease progression per RECIST 1.1, withdrawal of consent or any other condition of treatment discontinuation specified in the protocol. Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped. The trial was unblinded and study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

mPDAC, NIS793, Pancreas, metastatic pancreatic ductal adenocarcinoma (mPDAC), Nab-paclitaxel, Abraxane, Gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

511 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Safety run-in part: NIS793+gemcitabine+nab-paclitaxel

Arm Type

Experimental

Arm Description

In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.

Arm Title

Randomized part: NIS793+gemcitabine+nab-paclitaxel

Arm Type

Experimental

Arm Description

Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Arm Title

Randomized part: placebo+gemcitabine+nab-paclitaxel

Arm Type

Placebo Comparator

Arm Description

Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel Note: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.

Intervention Type

Drug

Intervention Name(s)

NIS793

Intervention Description

Concentrate for solution infusion (Liquid in Vial)

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Intervention Description

Per locally approved formulation

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Per locally approved formulation

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dextrose 5% in water (D5W) solution for infusion

Primary Outcome Measure Information:

Title

Safety run-in part: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.

Description

Time Frame

Up to 4 weeks

Title

Randomized part: Overall survival (OS)

Description

OS is defined as the time from date of randomization to date of death due to any cause.

Time Frame

From randomization up to death, assessed up to approximately 19 months

Secondary Outcome Measure Information:

Title

Percentage of participants with Adverse Events (AEs)

Description

Percentage of participants with AEs including changes in laboratory parameters, vital signs, body weight and cardiac assessments

Time Frame

Up to approximately 19 months

Title

Percentage of participants with dose interruptions and dose reductions of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Tolerability measured by the percentage of participants who have dose adjustments (interruptions or reductions) of NIS793

Time Frame

Up to approximately 19 months

Title

Dose intensity of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Tolerability measured by the dose intensity of NIS793. Dose intensity will be computed as the ratio of actual cumulative dose received and actual duration of exposure

Time Frame

Up to approximately 19 months

Title

Progression-free survival (PFS) by investigator assessment per RECIST 1.1

Description

Time Frame

From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 19 months

Title

Overall response rate (ORR) by investigator assessment per RECIST 1.1

Description

ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as per investigator assessment and according to RECIST 1.1

Time Frame

Up to approximately 19 months

Title

Disease control rate (DCR) by investigator assessment per RECIST 1.1

Description

DCR is the proportion of participants with BOR of CR or PR or stable disease (SD) as per investigator assessment and according to RECIST 1.1

Time Frame

Up to approximately 19 months

Title

Time to response (TTR) by investigator assessment per RECIST 1.1

Description

TTR is defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR.

Time Frame

From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 19 months

Title

Safety run-in part: Overall Survival (OS)

Description

OS is defined as the time from the date of enrollment to date of death due to any cause.

Time Frame

From enrollment up to death, assessed up to approximately 19 months

Title

Maximum concentration (Cmax) of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Blood samples will be collected for analysis of Cmax of NIS793

Time Frame

From date of first study drug intake up to approximately 19 months

Title

Trough Concentration (Ctrough) of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Blood samples will be collected for analysis of Ctrough of NIS793

Time Frame

From date of first study drug intake up to approximately 19 months

Title

Area under the curve from time zero to the last measurable concentration sampling time (AUClast) of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Blood samples will be collected for analysis of AUClast of NIS793

Time Frame

From date of first study drug intake up to approximately 19 months

Title

Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Blood samples will be collected for analysis of AUCtau of NIS793

Time Frame

From date of first study drug intake up to approximately 19 months

Title

Time to reach maximum concentration (Tmax) of NIS793 in combination with gemcitabine and nab-paclitaxel

Description

Blood samples will be collected for analysis of Tmax of NIS793

Time Frame

From date of first study drug intake up to approximately 19 months

Title

Randomized part: NIS793 serum concentration

Description

Blood samples will be collected for analysis of NIS793 serum concentration

Time Frame

From date of first study drug intake up to approximately 19 months

Title

Randomized part: Anti-drug antibodies (ADA) against NIS793 prevalence at baseline

Description

ADA (anti-NIS793) prevalence at baseline is defined as the proportion of participants who have an ADA positive result at baseline

Time Frame

Baseline

Title

Randomized part: ADA (anti-NIS793) incidence on treatment

Description

Time Frame

From date of first study drug intake up to approximately 19 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Applicable for both Safety run-in and Randomized part Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1 Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Adequate organ function (assessed by central laboratory for eligibility) Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia. Main Exclusion Criteria: Applicable for both Safety run-in and Randomized part Previous systemic anti-cancer treatment for metastatic PDAC Pancreatic neuroendocrine (islet) or acinar tumors Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening). Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment. Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed > 2 weeks prior to start of study treatment). Impaired cardiac function or clinically significant cardio-vascular disease Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment. Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding. Serious non-healing wounds. Pregnant or breast-feeding women Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated Pre-existing peripheral neuropathy > grade 1 (CTCAE v5.0)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group .

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

University Of California Los Angeles Santa Monica Location

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Advent Health Cancer Institute

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46815

Country

United States

Facility Name

NYU Clinical Cancer Center Dept of NYU Clin CancerCenter

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

NYU Clinical Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

US Oncology Research, Dallas .

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Facility Name

Houston Methodist Hospital OPC 26

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Novartis Investigative Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Novartis Investigative Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brasilia

State/Province

Distrito Federal

ZIP/Postal Code

70200-730

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-001

Country

Brazil

Facility Name

Novartis Investigative Site

City

Ijuí

State/Province

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04014-002

Country

Brazil

Facility Name

Novartis Investigative Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6R 3J7

Country

Canada

Facility Name

Novartis Investigative Site

City

Cambridge

State/Province

Ontario

ZIP/Postal Code

N1R 3G2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150081

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Novartis Investigative Site

City

Dalian

State/Province

Liaoning

ZIP/Postal Code

116001

Country

China

Facility Name

Novartis Investigative Site

City

Jining

State/Province

Shandong

ZIP/Postal Code

272000

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Novartis Investigative Site

City

Xian

State/Province

Shanxi

ZIP/Postal Code

710061

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300480

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100036

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Guangzhou

ZIP/Postal Code

510000

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200127

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Novartis Investigative Site

City

Novy Jicin

State/Province

Czech Republic

ZIP/Postal Code

74101

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

CZE

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

FIN-33521

Country

Finland

Facility Name

Novartis Investigative Site

City

Nice Cedex 2

State/Province

Alpes Maritimes

ZIP/Postal Code

06189

Country

France

Facility Name

Novartis Investigative Site

City

Besançon

State/Province

Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Avignon

ZIP/Postal Code

84082

Country

France

Facility Name

Novartis Investigative Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Novartis Investigative Site

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60488

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle S

ZIP/Postal Code

06120

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

540 07

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H 1122

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464 8681

Country

Japan

Facility Name

Novartis Investigative Site

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277 8577

Country

Japan

Facility Name

Novartis Investigative Site

City

Yokohama-city

State/Province

Kanagawa

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka-city

State/Province

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104 0045

Country

Japan

Facility Name

Novartis Investigative Site

City

Koto ku

State/Province

Tokyo

ZIP/Postal Code

135 8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3543 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nordbyhagen

State/Province

Oslo

ZIP/Postal Code

1478

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

NO 0450

Country

Norway

Facility Name

Novartis Investigative Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Pushkin Saint Petersburg

ZIP/Postal Code

196603

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

168583

Country

Singapore

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

83310

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

041 91

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Malmo

ZIP/Postal Code

SE-205 02

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umea

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bellinzona

ZIP/Postal Code

6500

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Geneve 14

ZIP/Postal Code

CH 1211

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Kuei Shan Chiang

State/Province

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01250

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Sihhiye / Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

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Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2

Metastatic Pancreatic Ductal Adenocarcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial