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The purpose of this signal seeking study is to determine whether treatment with PDR001 and LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.
This was a phase II, open-label study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to available standard of care therapies. There were 7 tumor cohorts assessed: 1) Small cell lung cancer, 2) Gastric/esophageal adenocarcinoma, 3) Castration resistant prostate adenocarcinoma (CRPC), 4) Soft tissue sarcoma, 5) Ovarian adenocarcinoma, 6) Advanced well-differentiated neuroendocrine tumors and 7) Diffuse large B cell lymphoma (DLBCL).
Participants were treated with the combination of PDR001 300 mg with LAG525 400 mg once every 3 weeks (Q3W) via intravenous (i.v.) infusion. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma criteria (Cheson et al 2007)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDR001+LAG525 | Experimental | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDR001 | Biological | PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, 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; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, 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. ORR (CR+PR) is reported overall (including all tumor types). |
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Inclusion Criteria:
Patients eligible for inclusion in this study had to meet all of the following criteria:
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center Drug Shipment (2) | San Francisco | California | 94120-7999 | United States | ||
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novctrd.com | View source |
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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.
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The screening period began once patients had signed the study informed consent. All screening evaluations were performed as closely as possible to the beginning of treatment and never more than 21 days prior to starting study treatment. After screening, the treatment period started on Cycle 1 Day 1.
Participants took part in 20 investigative sites in 1 country (United States).
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| ID | Title | Description |
|---|---|---|
| FG000 | PDR001+LAG525 | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2018 | Mar 24, 2021 |
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This is a phase II, open-label, study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to available standard of care therapies. Patients will receive study treatment for a maximum of 2 years. All disease assessments will be performed locally by the investigator.
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| LAG525 | Biological | LAG525 is a high-affinity, ligand-blocking, humanized anti-LAG-3 IgG4 antibody which blocks the binding of the known LAG-3 ligand MHC class II to LAG-3. |
|
| From start of treatment until end of treatment, assessed up to 113 weeks |
| Time to Response (TTR) | TTR is defined as the time from the date of first dose to the date of first documented response of Complete Response (CR) or Partial Response (PR). In case of solid tumor if a patient did not achieve a confirmed response they were censored at maximum follow-up for patients who had a PFS event (progressed or died due to any cause), or at last adequate tumor assessment date otherwise. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | From start of treatment to the first documented response of either complete response or partial response, assessed up to 113 weeks |
| Duration of Response (DOR) | DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented progression/relapse or death due to any cause within 150 days of the last study drug dose date. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | From first documented response (CR or PR) to first documented progression or death, assessed up to 113 weeks |
| Time to Progression (TTP) | TTP is the time from start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient not had an event, time to progression was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | From start of treatment to first documented progression or death due to underlying cancer, assessed up to 113 weeks |
| Progression-Free Survival (PFS) | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 150 days of the last dose. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | From start of treatment to first documented progression or death, assessed up to 113 weeks |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs including changes in laboratory parameters, vital signs and ECGs qualifying and reported as AEs. | From first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks. |
| Number of Participants With Dose Interruptions and Permanent Discontinuation of Study Drug | Number of participants with at least one dose interruption of PDR001 and LAG525 and number of participants with permanent dose discontinuation of PDR001 and LAG525. | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. |
| Dose Intensity | Dose intensity (mg/day) of PDR001 and LAG525 is calculated as cumulative dose in milligrams divided by duration of exposure in days. | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. |
| Hematology Oncology Associates of the Treasure Coast |
| Port Saint Lucie |
| Florida |
| 34952 |
| United States |
| University Cancer and Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Northwestern University Medical School | Chicago | Illinois | 60611 | United States |
| University of Illinois Cancer Center at Chicago SC | Chicago | Illinois | 60612 | United States |
| Illinois Cancer Care P.C. Jesse Brown VA | Peoria | Illinois | 61615-7828 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals and Clinics Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| The University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | United States |
| Weinberg Cancer Institute at Franklin Square Hospital | Baltimore | Maryland | 21237-3998 | United States |
| Billings Clinic Dept of Billings Clinic(2) | Billings | Montana | 59101 | United States |
| Oncology Hematology West Nebraska Cancer Specialists | Omaha | Nebraska | 68124 | United States |
| Comprehensive Cancer Centers | Las Vegas | Nevada | 89169 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Oncology Consultants Oncology Consultants | Houston | Texas | 77024 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Providence Regional Cancer System SC | Lacey | Washington | 98503 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Full Analysis Set (FAS) | The FAS includes all participants who received at least one dose of study treatment and had at least one valid post-baseline efficacy assessment. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PDR001+LAG525 | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, 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; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | 24 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, 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. ORR (CR+PR) is reported overall (including all tumor types). | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | From start of treatment until end of treatment, assessed up to 113 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR is defined as the time from the date of first dose to the date of first documented response of Complete Response (CR) or Partial Response (PR). In case of solid tumor if a patient did not achieve a confirmed response they were censored at maximum follow-up for patients who had a PFS event (progressed or died due to any cause), or at last adequate tumor assessment date otherwise. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | months | From start of treatment to the first documented response of either complete response or partial response, assessed up to 113 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented progression/relapse or death due to any cause within 150 days of the last study drug dose date. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | Participants in the Full Analysis Set (FAS) for whom best overall response is complete response (CR) or partial response (PR) | Posted | Median | 95% Confidence Interval | months | From first documented response (CR or PR) to first documented progression or death, assessed up to 113 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP is the time from start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient not had an event, time to progression was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | months | From start of treatment to first documented progression or death due to underlying cancer, assessed up to 113 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 150 days of the last dose. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). | Full Analysis Set (FAS) | Posted | Median | 95% Confidence Interval | months | From start of treatment to first documented progression or death, assessed up to 113 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with AEs and SAEs including changes in laboratory parameters, vital signs and ECGs qualifying and reported as AEs. | All participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks. |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose Interruptions and Permanent Discontinuation of Study Drug | Number of participants with at least one dose interruption of PDR001 and LAG525 and number of participants with permanent dose discontinuation of PDR001 and LAG525. | All participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. |
|
| |||||||||||||||||||||||||||||
| Secondary | Dose Intensity | Dose intensity (mg/day) of PDR001 and LAG525 is calculated as cumulative dose in milligrams divided by duration of exposure in days. | All participants who received at least one dose of study treatment | Posted | Mean | Standard Deviation | mg/day | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. |
|
|
In the on-treatment period, adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment. In the extended safety follow-up period, AEs and serious AEs (including the All-Cause Mortality data table) are presented from day 31 to day 150 after last administration of study treatment.
In the on-treatment period, any sign or symptom that occurs during the study treatment plus 30 days post treatment.
In the extended safety follow-up period, any sign or symptom that occurs between 31 and 150 days post treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PDR001+LAG525 On-treatment Period | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001 | 9 | 76 | 31 | 76 | 74 | 76 |
| EG001 | PDR001+LAG525 Extended Safety Follow-up Period | PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001 | 18 | 76 | 4 | 76 | 12 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Failure to thrive | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dizziness | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypercalcaemia | Endocrine disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ascites | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypothyroidism | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2021 | Mar 24, 2021 | SAP_000.pdf |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| C562730 | Adenocarcinoma Of Esophagus |
| D012509 | Sarcoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711728 | spartalizumab |
Not provided
Not provided
Not provided
| Caucasian |
|
| Unknown |
|
|
| Gastric/esophageal adenocarcinoma |
|
|
| Castration resistant prostate adenocarcinoma (CRPC) |
|
|
| Soft tissue sarcoma |
|
|
| Ovarian adenocarcinoma |
|
|
| Advanced well-differentiated neuroendocrine tumors |
|
|
| Diffuse large B cell lymphoma (DLBCL) |
|
|
|
|
|
|
|
|
|
|