Trial · NCT02460224
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
NCT02460224, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. Trials, record NCT02460224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02460224
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
- NCT number
- NCT02460224
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 490 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Advanced Solid Tumors
- Interventions
- LAG525, PDR001
- First posted
- 2015-06-02
- Last updated
- 2022-02-10
- Other registries' IDs
- eudract:2015-000449-21
- Results first posted
- 2022-02-10
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms | A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher. |
| Primary | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 2.6 years | Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). 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 diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type. |
| Secondary | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years. | Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record. |
| Secondary | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years. | Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type. |
| Secondary | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable. |
| Secondary | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type. |
| Secondary | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable. |
| Secondary | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day). The RDI of both study drugs is reported for each tumor type. |
| Secondary | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
| Secondary | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms.~Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 2.6 years | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years. | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years. | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001. | percentage | MEAN |
| SECONDARY | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | percentage | MEAN |
| SECONDARY | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | ug/mL | MEAN |
| SECONDARY | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | ug/mL | MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group1,229
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 1 mg/kg Q2W | 1 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 3 mg/kg Q2W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 5 mg/kg Q2W | 2 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 10 mg/kg Q2W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 15 mg/kg Q2W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 240 mg Q2W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 400 mg Q2W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 3 mg/kg Q4W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 5 mg/kg Q4W | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Phase 1: LAG525 10 mg/kg Q4W | 1 | Participants |
1 to 10 of 1,229Source ClinicalTrials.gov
See all 1,229 results by groupParticipant flow145
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: LAG525 1 mg/kg Q2W | 17 | |
| Overall Study | STARTED | Phase 1: LAG525 3 mg/kg Q2W | 12 | |
| Overall Study | STARTED | Phase 1: LAG525 5 mg/kg Q2W | 6 | |
| Overall Study | STARTED | Phase 1: LAG525 10 mg/kg Q2W | 6 | |
| Overall Study | STARTED | Phase 1: LAG525 15 mg/kg Q2W | 6 | |
| Overall Study | STARTED | Phase 1: LAG525 240 mg Q2W | 30 | |
| Overall Study | STARTED | Phase 1: LAG525 400 mg Q2W | 30 | |
| Overall Study | STARTED | Phase 1: LAG525 3 mg/kg Q4W | 5 | |
| Overall Study | STARTED | Phase 1: LAG525 5 mg/kg Q4W | 6 | |
| Overall Study | STARTED | Phase 1: LAG525 10 mg/kg Q4W | 11 |
1 to 10 of 145Source ClinicalTrials.gov
See all 145 participant flowAdverse events24,559
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 1 mg/kg Q2W | 3 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 3 mg/kg Q2W | 3 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 5 mg/kg Q2W | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 10 mg/kg Q2W | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 15 mg/kg Q2W | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 240 mg Q2W | 3 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 400 mg Q2W | 6 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 1 mg/kg Q2W-JP | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 240 mg Q2W-JP | 3 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: LAG525 400 mg Q2W-JP | 0 | 6 |
1 to 10 of 24,559Source ClinicalTrials.gov
See all 24,559 adverse eventsAdverse event totals123
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: LAG525 1 mg/kg Q2W | 1 | 13 |
| Total, all-cause mortality | Phase 1: LAG525 3 mg/kg Q2W | 0 | 12 |
| Total, all-cause mortality | Phase 1: LAG525 5 mg/kg Q2W | 0 | 6 |
| Total, all-cause mortality | Phase 1: LAG525 10 mg/kg Q2W | 0 | 6 |
| Total, all-cause mortality | Phase 1: LAG525 15 mg/kg Q2W | 0 | 6 |
| Total, all-cause mortality | Phase 1: LAG525 240 mg Q2W | 5 | 25 |
| Total, all-cause mortality | Phase 1: LAG525 400 mg Q2W | 3 | 24 |
| Total, all-cause mortality | Phase 1: LAG525 1 mg/kg Q2W-JP | 0 | 4 |
| Total, all-cause mortality | Phase 1: LAG525 240 mg Q2W-JP | 0 | 5 |
| Total, all-cause mortality | Phase 1: LAG525 400 mg Q2W-JP | 0 | 6 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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