Status:
TERMINATED
Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this trial was to explore the clinical utility of two investigational agents in patients with advanced cancer. This was a multi-center, open-label Phase I/Ib study. The primary objecti...
Detailed Description
This was a multi-center, open-label Phase I/Ib study. The study consisted of four dose escalation parts and two dose expansion parts testing LHC165 as a single agent or LHC165 in combination with PDR0...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained prior to any procedures unless considered standard of care.
- Adult men and women (≥ 18 years of age) with histologically confirmed diagnosis of metastatic and/or advanced solid tumors not amenable to curative treatment by surgery.
- Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Dose escalation: Patients with accessible tumors and with measurable disease as determined by RECIST 1.1 and have progressed despite standard treatment or are intolerant of standard treatment, or for whom no standard treatment exists.
- Dose expansion: Patients with advanced/metastatic solid tumors: HNSCC, melanoma, accessible tumors and visceral tumors (LHC165 combination with PDR001 only). Patients must have measurable disease as determined by RECIST 1.1 and have progressed despite standard treatment or are intolerant to standard treatment, or for whom no standard treatment exists• Patients must have at least two sites of disease amenable to biopsy.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Exclusion
- Presence of symptomatic or uncontrolled central nervous system (CNS) metastases requiring local CNS-directed treatment.
- Patients diagnosed with hematological malignancies.
- Patients with prior stem cell transplants.
- Patients previously treated with TLR-7/8 agonist treatment.
- History of primary immunodeficiency
- Patients who discontinued prior anti-PD-1/PD-L1 therapy due to an anti-PD-1/PD-L1-related toxicity.
- Malignant disease, other than that being treated in this study
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03301896
Start Date
January 31 2018
End Date
June 30 2022
Last Update
June 20 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA
Los Angeles, California, United States, 90095
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Novartis Investigative Site
Wilrijk, Belgium, 2610
4
Novartis Investigative Site
Ulm, Germany, 89081