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Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

Primary Purpose

Well-differentiated Non-functional NET of Thoracic Origin, Well-differentiated Non-functional NET of Gastrointestinal Origin, Well-differentiated Non-functional NET of Pancreatic Origin

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PDR001

About this trial

This is an interventional treatment trial for Well-differentiated Non-functional NET of Thoracic Origin focused on measuring Advanced or metastatic, NET, pNET, GI NET, thoracic NET, GEP-NEC

Eligibility Criteria

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

Inclusion Criteria:

Pathologically confirmed, advanced (unresectable or metastatic):
Well-differentiated (G1 or G2) based on local pathology report, non-functional neuroendocrine tumor of GI, pancreatic or thoracic (including lung and thymus) origin.
Poorly-differentiated GEP-NEC based on local pathology report
No active symptoms related to carcinoid syndrome during the last 3 months prior to start of study treatment.
Patients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depended on which origin for NET and for GEP-NEC
Tumor biopsy material must be provided for all patients for the purpose of biomarker analysis
Radiological documentation of disease progression:
Well-differentiated NET group: Disease progression while on/or after the last treatment, and this progression must have been observed within 6 months prior to start of study treatment (i.e. maximum of 24 weeks from documentation of progression until study entry). Disease must show evidence of radiological disease progression based on scans performed not more than 12 months apart.
Poorly-differentiated GEP-NEC group: Disease progression while on or after prior treatment.

Exclusion Criteria:

Well-differentiated grade 3 neuroendocrine tumors; poorly-differentiated neuroendocrine carcinoma of any origin (other than GEP-NEC); including NEC of unknown origin, adenocarcinoid, and goblet cell carcinoid
Pretreatment with interferon as last treatment prior to start of study treatment.
Prior treatment for study indication with:
Antibodies or immunotherapy within 6 weeks before the first dose of study treatment.
Peptide Radionuclide Receptor Therapy (PRRT) administered within 6 months of the first dose.
Systemic antineoplastic therapy
Tyrosine kinase inhibitors within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
Prior Programmed Death-1 (PD-1) or Programmed Death-Ligand 1 (PD-L1) directed therapy.
Cryoablation, radiofrequency ablation, or trans-arterial embolization of hepatic metastases
History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction.

Other inclusion/exclusion criteria might apply

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PDR001

Arm Description

Subjects with advanced or metastatic, well-differentiated, NET of pancreatic, GI, or thoracic origin or poorly-differentiated GEP-NEC, that have progressed on prior treatment were treated with 400mg PDR001 administered via intravenous infusion once every 4 weeks.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) by RECIST 1.1 and as Per Blinded Independent Central Review (BIRC).

ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to BIRC radiological assessment by RECIST 1.1. CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Secondary Outcome Measures

Duration of Response (DOR) by RECIST 1.1 and as Per BIRC

DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented disease progression by RECIST 1.1 and as per BIRC or death due to underlying cancer. For DOR analysis, participants continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. An adequate tumour assessment is a tumour assessment with an overall response other than unknown. CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Disease Control Rate by RECIST 1.1 and as Per BIRC

Disease control rate is defined as the proportion of patients with best overall response of CR, PR or stable disease (SD) according to RECIST 1.1 criteria and as per BIRC. CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Time to Response (TTR) by RECIST 1.1 and as Per BIRC

TTR is defined as the time from the date of start of treatment to the first documented response of either CR or PR, which must be subsequently confirmed. TTR was evaluated according to RECIST 1.1 and as per BIRC. CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Progression-free Survival (PFS) by RECIST 1.1 and as Per BIRC

PFS is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause. PFS was evaluated according to RECIST 1.1 and as per BIRC. For participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown.

Immune Related Overall Response Rate (irORR) by irRECIST and as Per BIRC

irORR is the proportion of patients with a best overall response of immune related Complete Response (irCR) or immune related partial response (irPR), according to BIRC assessment by irRECIST. irCR: Complete disappearance of all measurable and non-measurable lesions. In addition, any pathological lymph nodes must have a reduction in short axis to < 10 mm. irPR: At least 30% decrease in the total measurable tumor burden (TMTB) compared to baseline and not qualifying for irCR or immune related progressive disease (irPD).

Immune Related Duration of Response (irDoR) by irRECIST and as Per BIRC.

irDOR is defined as the time from first documentation of irCR or irPR until the time of first documentation of progression per irRECIST based on BIRC assessment. Participants continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. An adequate tumour assessment is a tumour assessment with an overall response other than unknown for irRECIST. irCR: Complete disappearance of all measurable and non-measurable lesions. In addition, any pathological lymph nodes must have a reduction in short axis to < 10 mm. irPR: At least 30% decrease in the TMTB compared to baseline and not qualifying for irPD or irCR

Immune Related Time to Response (irTTR) by irRECIST and as Per BIRC

irTTR is defined as the time between date of start of treatment until first documented response (confirmed irCR or irPR) by irRECIST and as per BIRC. irCR: Complete disappearance of all measurable and non-measurable lesions. In addition, any pathological lymph nodes must have a reduction in short axis to < 10 mm. irPR: At least 30% decrease in the TMTB compared to baseline and not qualifying for irPD or irCR.

Immune Related Disease Control Rate (irDCR) by irRECIST and as Per BIRC

irDCR is defined as the proportion of patients with a best overall response of irCR or irPR or immune related stable disease (irSD) according to irRECIST and as per BIRC. irCR: Complete disappearance of all measurable and non-measurable lesions. In addition, any pathological lymph nodes must have a reduction in short axis to < 10 mm. irPR: At least 30% decrease in the TMTB compared to baseline and not qualifying for irPD or irCR. irSD: Neither a sufficient shrinkage to qualify for irPR or irCR, nor an increase in lesions, or a clear and unequivocal progression of existing nontarget or new non-measurable lesions that would qualify for irPD.

Immune Related Progression Free Survival (irPFS) by irRECIST and as Per BIRC

irPFS is defined as the time from date of start of treatment to the date of event defined as the first documented assessment of immune related progression that is confirmed or death due to any cause. If a patient has not had an event, immune related progression-free survival was censored at the date of last adequate tumor assessment. An adequate tumor assessment is a tumor assessment with overall response other than unknown for irRECIST.

Overall Survival (OS)

OS is defined as the time from the start of treatment date to the date of death, due to any cause. If a patient was not known to have died, then OS was censored at the latest date the patient was known to be alive.

Changes From Baseline in Chromogranin A (CgA) Levels

Blood samples were collected for assessment of CgA level. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.

Change From Baseline in Neuron Specific Enolase (NSE) Levels

Blood samples were collected for assessment of NSE level. Change from Baseline at a particular visit was calculated as the NSE level at that visit minus Baseline.

PDR001 Plasma Concentration

Blood samples will be taken to evaluate the pharmacokinetics by assessing plasma concentration of PDR001 at selected time points

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life Score

The EORTC QLQ-C30 is a patient completed 30 item questionnaire that is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, six single items and a global health status/QoL scale. Global health status/QoL response options are 1 to 4. Scores were averaged and transformed to 0 to 100. Higher scores indicate better functioning. Change from Baseline was calculated by subtracting Baseline value from the selected visit value. A positive change from Baseline indicates improvement.

Change From Baseline in EQ-5D-5L Index Score

The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). Change from Baseline was calculated by subtracting Baseline value from the selected visit value. A positive change from baseline indicates improvement.

PDR001 Anti-drug Antibodies (ADA) Prevalence at Baseline

ADA prevalence at baseline was calculated as the proportion of participants who had an ADA positive result at baseline

PDR001 ADA Incidence On-treatment

ADA incidence on treatment was calculated as the proportion of participants who were 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

NCT02955069

First Posted

November 2, 2016

Last Updated

March 16, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02955069

Brief Title

Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

Official Title

An Open Label Phase II Study to Evaluate the Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), That Have Progressed on Prior Treatment.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 14, 2017 (Actual)

Primary Completion Date

August 10, 2018 (Actual)

Study Completion Date

May 13, 2020 (Actual)

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

5. Study Description

Brief Summary

This study aimed to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that progressed on prior treatment.

Detailed Description

Two groups of adult patients with advanced (unresectable or metastatic) were included in this study: Well-differentiated (G1/2), non-functional, neuroendocrine tumor of GI, pancreatic or thoracic (lung/thymus) origin who have progressed on prior treatment Poorly-differentiated GEP-NEC who have progressed on or after one prior chemotherapy regimen. The study was comprised of the following periods: screening, treatment, end of treatment (EOT), safety follow-up (30-Days, 60-Days, 90-Days, 120-Days, and 150-Days after the last dose of PDR001) and post-treatment efficacy follow-up. Subjects were treated with PDR001 as an infusion at a flat dose of 400 mg every 4 weeks (Q4W). Subjects were to continue study treatment beyond disease progression by RECIST 1.1 until disease progression as per irRECIST, as per BIRC, unacceptable toxicity, start of new antineoplastic therapy, withdrawal of consent, physician's decision, lost to follow-up, death, or study termination by the Sponsor.

6. Conditions and Keywords

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

Well-differentiated Non-functional NET of Thoracic Origin, Well-differentiated Non-functional NET of Gastrointestinal Origin, Well-differentiated Non-functional NET of Pancreatic Origin, Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma

Keywords

Advanced or metastatic, NET, pNET, GI NET, thoracic NET, GEP-NEC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PDR001

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

PDR001

Other Intervention Name(s)

Spartalizumab

Intervention Description

PDR001 was administered at a dose of 400 mg via intravenous infusion once every 4 weeks (Q4W). PDR001 was administered on Day 1 of every cycle. Each cycle was 28 days.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR) by RECIST 1.1 and as Per Blinded Independent Central Review (BIRC).

Description

Time Frame

From baseline up to approximately 1.5 years

Secondary Outcome Measure Information:

Title

Duration of Response (DOR) by RECIST 1.1 and as Per BIRC

Description

Time Frame

From the date of first documented response (CR or PR) until the first documented disease progression or death, whichever comes first, assessed up to approximately 1.5 years

Title

Disease Control Rate by RECIST 1.1 and as Per BIRC

Description

Time Frame

From baseline up to approximately 1.5 years

Title

Time to Response (TTR) by RECIST 1.1 and as Per BIRC

Description

Time Frame

From baseline to the first documented response, assessed up to approximately 1.5 years

Title

Progression-free Survival (PFS) by RECIST 1.1 and as Per BIRC

Description

Time Frame

From baseline until the date of the first documented radiological progression or death due to any cause, whichever comes first, assessed up to approximately 1.5 years

Title

Immune Related Overall Response Rate (irORR) by irRECIST and as Per BIRC

Description

Time Frame

From baseline up to approximately 1.5 years

Title

Immune Related Duration of Response (irDoR) by irRECIST and as Per BIRC.

Description

Time Frame

From the date of first documented confirmed response (irCR or irPR) until the first documented progression, assessed up to approximately 1.5 years

Title

Immune Related Time to Response (irTTR) by irRECIST and as Per BIRC

Description

Time Frame

From baseline to the first documented response, assessed up to approximately 1.5 years

Title

Immune Related Disease Control Rate (irDCR) by irRECIST and as Per BIRC

Description

Time Frame

From baseline up to approximately 1.5 years

Title

Immune Related Progression Free Survival (irPFS) by irRECIST and as Per BIRC

Description

Time Frame

From baseline until the date of the first documented immune related progression or death due to any cause, whichever comes first, assessed up to approximately 1.5 years

Title

Overall Survival (OS)

Description

Time Frame

From baseline until death due to any cause, assessed up to approx. 3 years

Title

Changes From Baseline in Chromogranin A (CgA) Levels

Description

Blood samples were collected for assessment of CgA level. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.

Time Frame

Baseline, day 1 of each cycle from Cycle 2 to end of treatment, assessed up to approx. 1.5 years. Cycle=28 days.

Title

Change From Baseline in Neuron Specific Enolase (NSE) Levels

Description

Blood samples were collected for assessment of NSE level. Change from Baseline at a particular visit was calculated as the NSE level at that visit minus Baseline.

Time Frame

Baseline, day 1 of each cycle from Cycle 2 to end of treatment, assessed up to approx. 1.5 years. Cycle= 28days

Title

PDR001 Plasma Concentration

Description

Blood samples will be taken to evaluate the pharmacokinetics by assessing plasma concentration of PDR001 at selected time points

Time Frame

Cycle(C)1 Day(D)1 pre-dose and 30min post-infusion,C2D1 Pre-dose,C3D1 Pre-dose and 30min post-infusion,D1 pre-dose from C4 to C13, assessed up to approx. 1.5 years.Cycle=28 days

Title

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life Score

Description

Time Frame

Baseline, every 8 weeks from Cycle 3 Day 1 for the first 13 cycles and every 12 weeks from Cycle 13 Day 1 thereafter and end of treatment, assessed up to approx. 1.5 years. Cycle=28 days

Title

Change From Baseline in EQ-5D-5L Index Score

Description

Time Frame

Baseline, every 8 weeks from Cycle 3 Day 1 for the first 13 cycles and every 12 weeks from Cycle 13 Day 1 thereafter, and end of treatment, assessed up to approx.1.5 year. Cycle=28 days

Title

PDR001 Anti-drug Antibodies (ADA) Prevalence at Baseline

Description

ADA prevalence at baseline was calculated as the proportion of participants who had an ADA positive result at baseline

Time Frame

Baseline

Title

PDR001 ADA Incidence On-treatment

Description

Time Frame

Cycle(C)1 Day(D)1 pre-dose and 30min post-infusion,C2D1 Pre-dose,C3D1 Pre-dose and 30min post-infusion,D1 pre-dose from C4 to C13 and every 6 cycles until C25, and end of treatment, assessed up to approx. 1.5 years. Cycle=28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed, advanced (unresectable or metastatic): Well-differentiated (G1 or G2) based on local pathology report, non-functional neuroendocrine tumor of GI, pancreatic or thoracic (including lung and thymus) origin. Poorly-differentiated GEP-NEC based on local pathology report No active symptoms related to carcinoid syndrome during the last 3 months prior to start of study treatment. Patients must have been pretreated for advanced disease - the number of prior systemic therapy/regimen depended on which origin for NET and for GEP-NEC Tumor biopsy material must be provided for all patients for the purpose of biomarker analysis Radiological documentation of disease progression: Well-differentiated NET group: Disease progression while on/or after the last treatment, and this progression must have been observed within 6 months prior to start of study treatment (i.e. maximum of 24 weeks from documentation of progression until study entry). Disease must show evidence of radiological disease progression based on scans performed not more than 12 months apart. Poorly-differentiated GEP-NEC group: Disease progression while on or after prior treatment. Exclusion Criteria: Well-differentiated grade 3 neuroendocrine tumors; poorly-differentiated neuroendocrine carcinoma of any origin (other than GEP-NEC); including NEC of unknown origin, adenocarcinoid, and goblet cell carcinoid Pretreatment with interferon as last treatment prior to start of study treatment. Prior treatment for study indication with: Antibodies or immunotherapy within 6 weeks before the first dose of study treatment. Peptide Radionuclide Receptor Therapy (PRRT) administered within 6 months of the first dose. Systemic antineoplastic therapy Tyrosine kinase inhibitors within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment. Prior Programmed Death-1 (PD-1) or Programmed Death-Ligand 1 (PD-L1) directed therapy. Cryoablation, radiofrequency ablation, or trans-arterial embolization of hepatic metastases History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction. Other inclusion/exclusion criteria might apply

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

City of Hope National Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Rocky Mountain Cancer Centers SC-2

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

H Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Mayo Clinic - Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

University of TX MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

BE-B-1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex 4

ZIP/Postal Code

31054

Country

France

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Meldola

State/Province

ZIP/Postal Code

47014

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

20141

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00189

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

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

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

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

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

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

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2PR

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

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Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)

Well-differentiated Non-functional NET of Thoracic Origin, Well-differentiated Non-functional NET of Gastrointestinal Origin, Well-differentiated Non-functional NET of Pancreatic Origin

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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