NCT02460224 · REGISTRY CONDITION SEARCH

Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2022-02-10

This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)

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outcome · POSTED

Phase 2: Overall Response Rate (ORR) Per RECIST 1.1

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outcome · POSTED

Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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outcome · POSTED

Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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outcome · POSTED

Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001

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outcome · POSTED

Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001

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outcome · POSTED

Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001

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outcome · POSTED

Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001

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outcome · POSTED

Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525

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outcome · POSTED

Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525

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outcome · POSTED

Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525

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outcome · POSTED

Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525

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outcome · POSTED

Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525

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outcome · POSTED

Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525

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outcome · POSTED

Phase 1: Terminal Elimination Half-life (T1/2) of LAG525

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outcome · POSTED

Phase 2: Terminal Elimination Half-life (T1/2) of LAG525

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outcome · POSTED

Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001

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outcome · POSTED

Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001

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outcome · POSTED

Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001

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outcome · POSTED

Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001

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outcome · POSTED

Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001

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outcome · POSTED

Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001

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outcome · POSTED

Phase 1: Terminal Elimination Half-life (T1/2) of PDR001

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outcome · POSTED

Phase 2: Terminal Elimination Half-life (T1/2) of PDR001

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outcome · POSTED

Phase 1: Number of Participants With Anti-LAG525 Antibodies

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outcome · POSTED

Phase 2: Number of Participants With Anti-LAG525 Antibodies

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outcome · POSTED

Phase 1: Number of Participants With Anti-PDR001 Antibodies

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outcome · POSTED

Phase 2: Number of Participants With Anti-PDR001 Antibodies

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outcome · POSTED

Phase 1: Overall Response Rate (ORR) Per RECIST 1.1

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outcome · POSTED

Phase 1: Overall Response Rate (ORR) Per irRC

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outcome · POSTED

Phase 2: Overall Response Rate (ORR) Per irRC

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outcome · POSTED

Phase 1: Disease Control Rate (DCR) Per RECIST 1.1

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outcome · POSTED

Phase 1: Disease Control Rate (DCR) Per irRC

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outcome · POSTED

Phase 2: Disease Control Rate (DCR) Per RECIST 1.1

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outcome · POSTED

Phase 2: Disease Control Rate (DCR) Per irRC

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outcome · POSTED

Phase 1: Duration of Response (DOR) Per RECIST 1.1

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outcome · POSTED

Phase 1: Duration of Response (DOR) Per irRC

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outcome · POSTED

Phase 2: Duration of Response (DOR) Per RECIST 1.1

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outcome · POSTED

Phase 2: Duration of Response (DOR) Per irRC

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outcome · POSTED

Phase 1: Progression-free Survival (PFS) Per RECIST 1.1

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outcome · POSTED

Phase 1: Progression-free Survival (PFS) Per irRC

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outcome · POSTED

Phase 2: Progression-free Survival (PFS) Per RECIST 1.1

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outcome · POSTED

Phase 2: Progression-free Survival (PFS) Per irRC

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: Phase I part: \- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists Phase II part: * Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups: * Group 1: NSCLC * Group 2: Melanoma * Group 3: Renal cancer * Group 4: Mesothelioma * Group 5: TNBC * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Exclusion Criteria: * History of severe hypersensitivity reactions to study treatment ingredients or other mAbs * Active, known or suspected autoimmune disease * Active infection requiring systemic antibiotic therapy * HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency * Patients receiving systemic treatment with any immunosuppressive medication * Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment * Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. * Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks * History of drug-induced pneumonitis or current pneumonitis.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Single-agent LAG525 1 mg/kg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 1 mg/kg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 3 mg/kg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 3 mg/kg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 5 mg/kg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 5 mg/kg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 10 mg/kg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 10 mg/kg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 15 mg/kg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 15 mg/kg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 240 mg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 240 mg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 400 mg Q2W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 400 mg Q2W
type
EXPERIMENTAL
description
Single-agent LAG525 3 mg/kg Q4W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 3 mg/kg Q4W
type
EXPERIMENTAL
description
Single-agent LAG525 5 mg/kg Q4W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 5 mg/kg Q4W
type
EXPERIMENTAL
description
Single-agent LAG525 10 mg/kg Q4W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 10 mg/kg Q4W
type
EXPERIMENTAL
description
Single-agent LAG525 400 mg Q4W
intervention Names
Drug: LAG525
label
Phase 1: LAG525 400 mg Q4W
type
EXPERIMENTAL
description
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
intervention Names
Drug: LAG525
Drug: PDR001
label
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
type
EXPERIMENTAL

interventions

arm Group Labels
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Phase 1: LAG525 1 mg/kg Q2W
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q4W
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Phase 1: LAG525 15 mg/kg Q2W
Phase 1: LAG525 240 mg Q2W
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Phase 1: LAG525 3 mg/kg Q2W
description
LAG525 was administered via intravenous (i.v.) infusion
name
LAG525
type
DRUG
arm Group Labels
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
description
PDR001 was administered via i.v. infusion
name
PDR001
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 490
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
time Frame
15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
description
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.
measure
Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
time Frame
From start of treatment until end of treatment, assessed up to 2.6 years

secondary Outcomes

description
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.
measure
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time Frame
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
description
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.
measure
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time Frame
From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
description
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.
measure
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
time Frame
From start of treatment until end of treatment, assessed up to 4.4 years.
description
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.
measure
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
time Frame
From start of treatment until end of treatment, assessed up to 2.6 years.
description
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.
measure
Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
time Frame
From start of treatment until end of treatment, assessed up to 4.4 years.
description
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.
measure
Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
time Frame
From start of treatment until end of treatment, assessed up to 2.6 years.
description
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.
measure
Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
time Frame
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).
description
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.
measure
Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
time Frame
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).
description
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
measure
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
time Frame
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).
description
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
measure
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
time Frame
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).
description
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
measure
Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
time Frame
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).
description
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
measure
Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
time Frame
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).

Full study description

brief Summary: This study was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at the MTD or RP2D.
detailed Description: This was a Phase 1/2, multi-center, open-label study comprising a Phase 1 dose escalation part followed by a Phase 2 dose expansion part. During the Phase 1 dose escalation part patients with any advanced solid tumor received the study treatment until the MTD was reached or a lower RP2D was established. The study had the following 3 dose escalation parts: 1) Single-agent LAG525; 2) Single-agent LAG525 in Japanese patients; 3) Combination of LAG525 with PDR001. Once the RP2D or MTD had been determined in the escalation parts, additional patients were to be enrolled in the Phase 2 expansion parts in order to assess the preliminary anti-tumor activity. Phase 2 expansion cohorts testing single-agent LAG525 were not opened for enrollment based on emerging data including but not limited to preliminary anti-tumor activity. Phase 2 expansion cohorts for the combination of LAG525 with PDR001 were opened and 5 tumor types were assessed: 1) Non-small cell lung cancer (NSCLC); 2) Melanoma; 3) Renal cell cancer (RCC); 4) Mesothelioma; 5) Triple negative breast cancer (TNBC). The efficacy and safety of the combination of LAG525 with PDR001 in these tumor types was assessed in both the PD-1/PD-L1 pre-treated and naïve settings.

Source references

references

citation
Rivoltini L, Camisaschi C, Fuca G, Paolini B, Vergani B, Beretta V, Damian S, Duca M, Cresta S, Magni M, Leone BE, Castelli C, de Braud F, De Santis F, Di Nicola M. Immunological characterization of a long-lasting response in a patient with metastatic triple-negative breast cancer treated with PD-1 and LAG-3 blockade. Sci Rep. 2024 Feb 9;14(1):3379. doi: 10.1038/s41598-024-54041-9.
pmid
38336861
type
DERIVED
citation
Schoffski P, Tan DSW, Martin M, Ochoa-de-Olza M, Sarantopoulos J, Carvajal RD, Kyi C, Esaki T, Prawira A, Akerley W, De Braud F, Hui R, Zhang T, Soo RA, Maur M, Weickhardt A, Krauss J, Deschler-Baier B, Lau A, Samant TS, Longmire T, Chowdhury NR, Sabatos-Peyton CA, Patel N, Ramesh R, Hu T, Carion A, Gusenleitner D, Yerramilli-Rao P, Askoxylakis V, Kwak EL, Hong DS. Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) +/- anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies. J Immunother Cancer. 2022 Feb;10(2):e003776. doi: 10.1136/jitc-2021-003776.
pmid
35217575
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice