Novartis recruiting

History of Changes for Study: NCT02460224
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
Latest version (February 22, 2018) on ClinicalTrials.gov

• A study version is represented by a row in the table.
• Select two study versions to compare. One each from columns A and B.
• Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
• Click "Compare" to do the comparison and show the differences.
• Select a version's date link to see a rendering of the study for that version.
• Edits or deletions will be displayed in red.
• Additions will be displayed in green.
• The yellow choices in the table indicate the study versions currently compared below. A yellow row indicates the study version being viewed.

Study Record Versions

	Version	A	B	Date	Changes
1	1	May 29, 2015	Nothing (earliest Version on record)
2	2	November 9, 2015	Contacts/Locations and Study Status
3	3	January 7, 2016	Contacts/Locations, Study Status and Study Identification
4	4	June 1, 2016	Study Status, Arms and Interventions, Contacts/Locations, Eligibility, Study Design, Conditions, Study Description and Oversight
5	5	July 13, 2016	Contacts/Locations and Study Status
6	6	August 15, 2016	Contacts/Locations and Study Status
7	7	September 15, 2016	Study Status and Contacts/Locations
8	8	October 18, 2016	Contacts/Locations and Study Status
9	9	February 2, 2017	Oversight, Contacts/Locations, Study Status, Study Design and Study Identification
10	10	February 27, 2017	Study Status
11	11	May 17, 2017	Contacts/Locations, Oversight and Study Status
12	12	June 26, 2017	Study Status and Contacts/Locations
13	13	September 22, 2017	Contacts/Locations, Oversight, Study Status, IPDSharing, Eligibility and Conditions
14	14	November 15, 2017	Contacts/Locations, Study Status, Eligibility, Outcome Measures and Study Design
15	15	December 14, 2017	Study Status
16	16	February 22, 2018	Study Status and Contacts/Locations

Comparison Format:

• Merged
• Side-by-Side

Scroll up to access the controls
Study NCT02460224
on Date:  February 22, 2018 (v16)

	Column 1	Column 2	Column 3	Column 4	Column 5
0	Study Identification Column 1 0 Unique Protocol ID:	CLAG525X2101CBrief Title:	Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.Official Title:	A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced MalignanciesSecondary IDs:

Study Status

	Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7	Column 8	Column 9	Column 10	Column 11
0	Record Verification:	February 2018Overall Status:	RecruitingStudy Start:	January 8, 2015Primary Completion:	April 23, 2019 [Anticipated]Study Completion:	April 23, 2019 [Anticipated] First Submitted:	May 9, 2015First Submitted that met QC criteria:	May 29, 2015First Posted:	June 2, 2015 [Estimate] Last Update Submitted that Met QC Criteria:	February 22, 2018Last Update Posted:	February 23, 2018 [Actual]

Sponsor/Collaborators

	Column 1	Column 2	Column 3	Column 4
0	Sponsor:	Novartis PharmaceuticalsResponsible Party:	SponsorCollaborators:

Oversight

	Column 1	Column 2	Column 3	Column 4
0	U.S. FDA-regulated Drug:	YesU.S. FDA-regulated Device:	NoData Monitoring:	No

Study Description

	Column 1	Column 2	Column 3
0	Brief Summary:	This study is 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 (I) 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 (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.Detailed Description:

Conditions

	Column 1	Column 2	Column 3
0	Conditions:	Advanced Solid TumorsKeywords:	Non-small cell lung cancerMelanomaRenal cancerMesotheliomaTriple Negative BreastTNBCRenal

Study Design

	Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7	Column 8	Column 9
0	Study Type:	InterventionalPrimary Purpose:	TreatmentStudy Phase:	Phase 1Interventional Study Model:	Parallel AssignmentNumber of Arms:	3Masking:	None (Open Label)Allocation:	Non-RandomizedEnrollment:	515 [Anticipated]

Arms and Interventions

	Column 1	Column 2	Column 3	Column 4	Column 5
0	Arms	Assigned InterventionsExperimental: Arm ASingle agent treatment arm with LAG525	Drug: LAG525study drug 1Experimental: Arm B: combination of LAG525 and PDR001Combination treatment arm with LAG525 and PDR001	Drug: LAG525study drug 1Drug: PDR001study drug 2Experimental: Arm CSingle agent treatment arm with LAG525 in Japanese pts	Drug: LAG525study drug 1

[/table]
Outcome Measures

	Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7	Column 8	Column 9	Column 10	Column 11	Column 12	Column 13	Column 14	Column 15	Column 16	Column 17	Column 18	Column 19	Column 20
0	Primary Outcome Measures:	1.	Phase I part: Incidence of dose limiting toxicities (DLTs)A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value 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 Phase I part: Incidence of dose limiting toxicities (DLTs)[Time Frame: 30 months]2.	Phase II part: Overall response Rate per RECIST V1.1Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on local Investigator assessment, as defined in RECIST v1.1. Estimation of the true ORR in this part of the study will be based upon the observed ORR for patients in full analysis set. Phase II part: Overall response Rate per RECIST V1.1[Time Frame: 30 months]Secondary Outcome Measures:	3.	AUCCharacterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 AUC[Time Frame: 30 months]4.	Presence and/ or concentration of anti-LAG525 and anti-PDR001 antibodiesAssess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 Presence and/ or concentration of anti-LAG525 and anti-PDR001 antibodies[Time Frame: 30 months]5.	Correlation of PD-L1, Lymphocyte activation gene-3 LAG-3 expressionAssess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 Correlation of PD-L1, Lymphocyte activation gene-3 LAG-3 expression[Time Frame: 30 months]6.	Overall response Rate (ORR)Evaluate the preliminary antitumor activity per RECIST as well as per immune related Response Criteria (irRC) on single agent LAG525 given alone or in combination with PDR001 Overall response Rate (ORR)[Time Frame: 30 months]7.	Expression of IFN-γ immune-related genes by mRNA profilingAssess the pharmacodynamic effect of single agent LAG525 and the combination of LAG525 and PDR001 Expression of IFN-γ immune-related genes by mRNA profiling[Time Frame: 30 months]8.	Safety incidence of Adverse Events (AEsCharacterize the safety of single agent LAG525 given alone and in combination with PDR001 Safety incidence of Adverse Events (AEs[Time Frame: 30 months]9.	Tolerability measured by dose interruptionsCharacterize the tolerability of single agent LAG525 given alone and in combination with PDR001 Tolerability measured by dose interruptions[Time Frame: 30 months]10.	Progression free survival (PFS)Evaluate the preliminary antitumor activity per RECIST as well as per immune related Response Criteria (irRC) on single agent LAG525 given alone or in combination with PDR001 Progression free survival (PFS)[Time Frame: 30 months]11.	Duration of response (DOR)Evaluate the preliminary antitumor activity per RECIST as well as per immune related Response Criteria (irRC) on single agent LAG525 given alone or in combination with PDR001 Duration of response (DOR)[Time Frame: 30 months]12.	Disease control rate (DCR)Evaluate the preliminary antitumor activity per RECIST as well as per immune related Response Criteria (irRC) on single agent LAG525 given alone or in combination of PDR001 Disease control rate (DCR)[Time Frame: 30 months]13.	Safety measuresd by incidence of Serious Adverse Events (SAEs)Characterize the safety of single agent LAG525 given alone and in combination with PDR001 Safety measuresd by incidence of Serious Adverse Events (SAEs)[Time Frame: 30 months]14.	CmaxCharacterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 Cmax[Time Frame: 30 months]15.	TmaxCharacterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 Tmax[Time Frame: 30 months]16.	half-lifeCharacterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 half-life[Time Frame: 30 months]17.	Tolerability measured by dose reductionsCharacterize the tolerability of single agent LAG525 given alone and in combination with PDR001 Tolerability measured by dose reductions[Time Frame: 30 months]

Eligibility

	Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7
0	Minimum Age:	18 YearsMaximum Age:	Sex:	AllGender Based:	Accepts Healthy Volunteers:	NoCriteria:	Inclusion Criteria: Phase I part: - Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 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.

Contacts/Locations

	Column 1	Column 2	Column 3	Column 4	Column 5	Column 6	Column 7	Column 8	Column 9	Column 10	Column 11	Column 12	Column 13	Column 14	Column 15	Column 16	Column 17	Column 18	Column 19	Column 20	Column 21	Column 22	Column 23	Column 24	Column 25	Column 26	Column 27	Column 28	Column 29	Column 30	Column 31	Column 32	Column 33	Column 34	Column 35	Column 36	Column 37	Column 38	Column 39	Column 40	Column 41	Column 42	Column 43	Column 44	Column 45	Column 46	Column 47
0	Central Contact:	Novartis PharmaceuticalsTelephone: 1-888-669-6682Email: [email protected] Contact Backup:	Novartis PharmaceuticalsTelephone: +41613241111Study Officials:	Novartis PharmaceuticalsStudy DirectorNovartis PharmaceuticalsLocations:	United States, New York	Novartis Investigative Site[Recruiting]New York, New York, United States, 10032Contact: Fawzia MacLeod Ibrahim +1 212 304 5686 [email protected] Investigator: Naiyer Rizvi	Novartis Investigative Site[Recruiting]New York, New York, United States, 10065Contact: Alexander Shea 646-888-4438 [email protected] Investigator: Neil H. Segal	United States, North Carolina	Novartis Investigative Site[Recruiting]Durham, North Carolina, United States, 27704Contact: Leslie Lewis 919-684-6342 [email protected] Investigator: Tian Zhang	United States, Texas	Novartis Investigative Site[Recruiting]Houston, Texas, United States, 77030-4009Contact: Ashley D Herrick 713-792-2921 [email protected] Investigator: David Hong	Novartis Investigative Site[Recruiting]San Antonio, Texas, United States, 78229Contact: Ofelia Romero 210-450-1789 [email protected] Investigator: John Sarantopoulos	United States, Utah	Novartis Investigative Site[Recruiting]Salt Lake City, Utah, United States, 84112Contact: Keisa Hales 801-587-5597 [email protected] Investigator: Kenneth Grossmann	Australia, New South Wales	Novartis Investigative Site[Recruiting]Westmead, New South Wales, Australia, 2145	Australia, Victoria	Novartis Investigative Site[Recruiting]Heidelberg, Victoria, Australia, 3084	Belgium	Novartis Investigative Site[Recruiting]Leuven, Belgium, 3000	Canada, Alberta	Novartis Investigative Site[Recruiting]Edmonton, Alberta, Canada, T6G 1Z2	Canada, Ontario	Novartis Investigative Site[Recruiting]Toronto, Ontario, Canada, M5G 2M9	France	Novartis Investigative Site[Recruiting]Lyon Cedex, France, 69373	Novartis Investigative Site[Recruiting]Saint-Herblain Cédex, France, 44805	Germany	Novartis Investigative Site[Recruiting]Heidelberg, Germany, 69120	Novartis Investigative Site[Recruiting]Wurzburg, Germany, 97080	Hong Kong	Novartis Investigative Site[Recruiting]Hong Kong, Hong Kong	Italy, MI	Novartis Investigative Site[Recruiting]Milano, MI, Italy, 20133	Italy, MO	Novartis Investigative Site[Recruiting]Modena, MO, Italy, 41124	Japan, Fukuoka	Novartis Investigative Site[Recruiting]Fukuoka-city, Fukuoka, Japan, 811-1395	Singapore	Novartis Investigative Site[Recruiting]Singapore, Singapore, 119228	Novartis Investigative Site[Recruiting]Singapore, Singapore, 169610	Spain, Catalunya	Novartis Investigative Site[Recruiting]Barcelona, Catalunya, Spain, 08035	Spain	Novartis Investigative Site[Recruiting]Madrid, Spain, 28007	Taiwan	Novartis Investigative Site[Recruiting]Taipei, Taiwan, 10002

IPDSharing

	Column 1	Column 2
0	Plan to Share IPD:	UndecidedNovartis 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 [url="http://www.clinicalstudydatarequest.com

"]www.clinicalstudydatarequest.com[/P][/table][/url]
References

	Column 1	Column 2	Column 3
0	Citations:	Links:	Available IPD/Information:

[/table]
Scroll up to access the controlsScroll to the Study top
U.S. National Library of Medicine | U.