World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 December 2018
Main ID:  NCT03301896
Date of registration: 29/09/2017
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: Study of the Safety and Efficacy of LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
Scientific title: A Phase I/Ib, Open-label, Multi-center Dose-escalation and Dose-expansion Study of the Safety and Tolerability of Intra-tumorally Administered LHC165 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies
Date of first enrolment: January 31, 2018
Target sample size: 200
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03301896
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Belgium Canada France Germany Italy Japan Korea, Republic of Spain
United States
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone: 1-888-669-6682
Email: Novartis.email@novartis.com
Affiliation: 
Name:     Nehal Parikh, MD
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Solid Tumors
Intervention(s)
Biological: PDR001
Drug: LHC165
Primary Outcome(s)
Escalation and Expansion: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs), including changes in laboratory parameters, vital signs, electrocardiograms (ECGs) [Time Frame: 24 months]
Escalation: Incidence of Dose-limiting Toxicities (DLTs) in Cycle 1 [Time Frame: day 28]
Secondary Outcome(s)
Best Overall Response (BOR) per RECIST 1.1 and iRECIST [Time Frame: 24 months]
Change from baseline in tumor infiltrating lymphocytes in injected and distal tumor specimens [Time Frame: 24 months]
Disease Control Rate (DCR) per RECIST 1.1 and iRECIST [Time Frame: 24 months]
Duration of Response (DOR) per RECIST 1.1 and iRECIST [Time Frame: 24 months]
Objective Response Rate (ORR) per RECIST 1.1 and iRECIST [Time Frame: 24 months]
Presence and titer of anti-PDR001 antibodies [Time Frame: 24 months]
Progression-Free Survival (PFS) per RECIST 1.1 and iRECIST [Time Frame: 24 months]
Serum concentration profiles of LHC165 as a single agent: AUC [Time Frame: 24 months]
Serum concentration profiles of LHC165 as a single agent: Cmax [Time Frame: 24 months]
Serum concentration profiles of LHC165 as a single agent: Tmax [Time Frame: 24 months]
Serum concentration profiles of LHC165 in combination with PDR001 and derived PK parameters: AUC [Time Frame: 24 months]
Serum concentration profiles of LHC165 in combination with PDR001 and derived PK parameters: Cmax [Time Frame: 24 months]
Serum concentration profiles of LHC165 in combination with PDR001 and derived PK parameters: Tmax [Time Frame: 24 months]
Serum concentration profiles of PDR001 in combination with LHC165 and derived PK parameters: AUC [Time Frame: 24 months]
Serum concentration profiles of PDR001 in combination with LHC165 and derived PK parameters: Cmax [Time Frame: 24 months]
Serum concentration profiles of PDR001 in combination with LHC165 and derived PK parameters: Tmax [Time Frame: 24 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history