A Phase 1 interventional study of LHC165 and PDR001 in Solid Tumors, sponsored by Novartis Pharmaceuticals. Terminated at 9 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 53 studies in Melanoma by Novartis — 1 open to participants now, 6 under way, none of them phase 3. Melanoma · Novartis.
Among the 53 studies in Melanoma by Novartis, this one is the 35th largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2018, is one of 12 in phase 1, and was the 27th registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →1 of the 53 studies in Melanoma by Novartis is open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Argentina, Austria and 12 more countries
Ages 18–100
By country, each count listing its studies:
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 17 · Phase 3 6 · Phase 4 2
First in 1998; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is above the median of 40 across 2,650 interventional studies indexed under Melanoma.
Median enrollment 134 across the 37 interventional studies, 379 across the 14 observational. Of the 45 that completed or were terminated, 18 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
4 of the studies in Melanoma by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04417621Novartis PharmaceuticalsStudy of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma | 2027-02-02 |
| NCT03891953Novartis PharmaceuticalsStudy of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. | 2027-06-25 |
| NCT05415072Novartis PharmaceuticalsA Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas | 2027-10-01 |
| NCT05544929Novartis PharmaceuticalsA Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers | 2027-10-05 |
Add all 4 to your calendar (.ics) → With an account.
Among the 53 studies in Melanoma by Novartis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 objectives of the trial were:
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 PDR001. The dose escalation parts estimated the Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion (RDE) and were planned to test two different dosing schedules for LHC165 single agent (Group A and B) and LHC165 in combination with PDR001 (Group C and D).
The dose expansion parts of the study were planned to use the MTD/RDE for each the LHC165 single agent (Group E) and LHC165 in combination with PDR001 (Group F), determined in the respective dose escalation parts to assess the activity, safety and tolerability of LHC165 as a single agent or LHC165 in combination with PDR001 in patients with specific types of solid tumors.
The study was terminated due to business reasons. Groups B, D and E were not opened for enrollment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LHC165 intratumoral injection given alone
Drug: LHC165
LHC165 intratumoral injection given with PDR001 infusion
Drug: LHC165 · Biological: PDR001
LHC165 intratumoral injection
PDR001 infusion
Escalation: Incidence of Dose-limiting Toxicities (DLTs) in Cycle 1
Dose Limiting Toxicity Evaluation Period
Time frame: day 28
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
Objective Response Rate (ORR) per RECIST 1.1 and iRECIST
Time frame: 24 months
Best Overall Response (BOR) per RECIST 1.1 and iRECIST
Time frame: 24 months
Progression-Free Survival (PFS) per RECIST 1.1 and iRECIST
Time frame: 24 months
Duration of Response (DOR) per RECIST 1.1 and iRECIST
Time frame: 24 months
Disease Control Rate (DCR) per RECIST 1.1 and iRECIST
Time frame: 24 months
Serum concentration profiles of LHC165 as a single agent: Cmax
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 PDR001 in combination with LHC165 and derived PK parameters: Cmax
Time frame: 24 months
Serum concentration profiles of LHC165 as a single agent: AUC
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 PDR001 in combination with LHC165 and derived PK parameters: AUC
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: Tmax
Time frame: 24 months
Serum concentration profiles of PDR001 in combination with LHC165 and derived PK parameters: Tmax
Time frame: 24 months
Presence and titer of anti-PDR001 antibodies
Time frame: 24 months
Change from baseline in tumor infiltrating lymphocytes in injected and distal tumor specimens
Time frame: 24 months
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2022, 52 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.