Phase 2
N=76
PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
Small Cell Lung Cancer · Gastric Adenocarcinoma · Esophageal Adenocarcinoma · Castration Resistant Prostate Adenocarcinoma · Soft Tissue Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT03365791 ↗Enrolled (actual)
76
Serious AEs
23.0%
Results posted
Apr 2021
Primary outcome: Primary: Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma — 25; 3; 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PDR001 (Biological); LAG525 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma |
25; 3; 2; 5; 4; 2 | — |
| SECONDARY Overall Response Rate (ORR) |
7 | — |
| SECONDARY Time to Response (TTR) |
NA | — |
| SECONDARY Duration of Response (DOR) |
NA | — |
| SECONDARY Time to Progression (TTP) |
2.8 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.8 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
75; 32 | — |
| SECONDARY Number of Participants With Dose Interruptions and Permanent Discontinuation of Study Drug |
30; 72; 30; 72 | — |
| SECONDARY Dose Intensity |
14.1; 18.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
Patients eligible for inclusion in this study had to meet all of the following criteria:
- Patient must have had at least one prior line of therapy for their disease and must not be beyond 4th progression/relapse of disease (5 maximum prior lines).
- Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the section "condition". Patients must have measurable disease as per appropriate guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised Response Criteria for Malignant Lymphoma - Cheson et al 2007).
Exclusion Criteria
Patients eligible for this study must not meet any of the following criteria:
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Impaired cardiac function or clinically significant cardiac disease.
- Active, known or suspected autoimmune disease or a documented history of autoimmune disease within three years prior to screening with a few exceptions as per protocol.
- Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- Patient with second primary malignancy within < 3 years of first dose of study treatment.
- Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies.
Data sourced from ClinicalTrials.gov (NCT03365791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.