Phase 2
Completed 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
Source: ClinicalTrials.gov NCT03365791 ↗
Enrolled (actual)
76
Serious AEs
23.0%
Results posted
Apr 2021
Primary outcomePrimary: Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma — 25; 3; 2; 5 Participants
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.
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 | — |
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. Informational only — not medical advice.