A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer

Official Title

A Phase II Open-label, Randomized, Three-arm, Multicentre Study of LAG525 Given in Combination With Spartalizumab (PDR001), or With Spartalizumab and Carboplatin, or With Carboplatin, as First or Second Line Therapy in Patients With Advanced Triple-negative Breast Cancer

Summary:

The purpose of this study is to assess the efficacy, safety, and PK characteristics of the following three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. A thorough biomarker strategy to address key aspects of tumour immunogenicity will be implemented in the study. LAG525 and spartalizumab are two immuno-agents targeting different immune checkpoints, and have been tested as single agents and in combination. To further enhance the efficacy of checkpoint inhibition, carboplatin will be given with LAG525 or with LAG525 and spartalizumab, based on the observation that the addition of chemotherapy can change the tumour microenvironment to be more favourable to immune response.

Trial Description

Primary Outcome:

  • Overall response rate (ORR) per RECIST v1.1 per investigators' assessment
Secondary Outcome:
  • Duration of response (DOR)
  • Overall Survival (OS)
  • Pharmacokinetics (PK) parameter, Ctrough, of LAG525, spartalizumab and carboplatin
  • Time to response (TTR)
  • Progression free survival (PFS)
  • Clinical Benefit Rate (CBR)
  • PK parameter, Cmax of LAG525, spartalizumab and carboplatin
  • PK parameter, AUC, of LAG525, spartalizumab and carboplatin
  • Anti-drug antibodies (ADA) prevalence at baseline for LAG525 and spartalizumab
  • Anti-drug antibodies (ADA) incidence on treatment for LAG525 and spartalizumab
The sponsor and the study steering committee decided to prematurely stop enrollment of subjects to Arm 1 after data review showed an increased treatment discontinuation rate due to progressive disease in Arm 1 as compared to Arms 2 and 3 (both containing Carboplatin).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society