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LAG-3 Inhibitor

PDR001+LAG525 for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks.
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Prostate Cancer
  • Soft Tissue Sarcoma
  • Non-Hodgkin's Lymphoma
  • Neuroendocrine Tumors
  • Ovarian Cancer
  • Small Cell Lung Cancer
  • Stomach Cancer
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma
Secondary study objectives
Dose Intensity
Duration of Response (DOR)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PDR001+LAG525Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2890
LAG525
2018
Completed Phase 2
~850

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,909 Previous Clinical Trials
4,209,993 Total Patients Enrolled
~10 spots leftby Nov 2025
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