Phase 2 Mesothelioma Trial, Completed NCT02460224 Sponsor: Novartis Pharmaceuticals Condition: Mesothelioma
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02460224) enrolled a total of 512 participants across many different treatment groups. It was a two-phase study testing an experimental drug called LAG525, both on its own and combined with another drug called PDR001, in people with advanced cancer. Phase 1 aimed to find appropriate doses by looking at how many people experienced serious side effects early in treatment (called dose-limiting toxicities — that is, harmful reactions severe enough to limit how much drug could be given). Phase 2 then looked at how many participants' tumours responded to the combination treatment, measured using a standard set of imaging-based rules called RECIST 1.1. The reported data shows that in Phase 1, dose-limiting toxicities were uncommon across most dosing groups. Out of the groups where this was reported, only a small number of individuals experienced them — for example, 1 participant in the lowest single-agent dose group, 2 in another single-agent group, and 1 in one of the combination groups; the remaining groups reported zero dose-limiting toxicities. For Phase 2, the reported outcome measuring tumour response (called Overall Response Rate, or ORR — meaning the percentage of people whose tumour either disappeared completely or shrank by at least 30%) varied across cancer types and treatment groups. In the treatment-naïve group (people who had not previously received this type of treatment) receiving one dosing schedule, ORR figures ranged from approximately 14% to 26% depending on tumour type, while in the previously treated group the reported figures were generally lower, ranging from around 0% to 9%. Some figures for certain subgroups were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Mesothelioma Trial, Completed

NCT02460224
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • (Phase I part) You have an advanced or spreading solid tumour cancer that can or cannot be measured on scans, and your cancer has continued to grow despite standard treatment, you could not tolerate standard treatment, or no standard treatment exists for your cancer.
  • (Phase II part) You have an advanced or spreading solid tumour cancer with at least one area that can be measured on scans, and your cancer has gotten worse after your most recent treatment.
  • (Phase II part) Your cancer is one of the following types: non-small cell lung cancer (NSCLC), melanoma (skin cancer), kidney cancer, mesothelioma, or triple-negative breast cancer (TNBC).
  • (Phase II part) You are generally well enough to carry out light activity and care for yourself, based on a standard fitness scoring system (confirm with trial site).
  • (Phase II part) You have an area of cancer that a doctor can safely take a small tissue sample (biopsy) from, and you are able to have this procedure done.

Who may not be able to join:

  • You have had a severe allergic reaction in the past to any ingredient in the study treatment or to similar types of medicines called monoclonal antibodies.
  • You currently have, or are suspected to have, an active autoimmune disease (a condition where your immune system attacks your own body).
  • You have an active infection that is currently being treated with antibiotic medicines given throughout your body (not just on the skin).
  • You are living with HIV, or you have an active hepatitis B or hepatitis C infection.
  • You are regularly taking steroid medicines (except for low "replacement" doses used to treat a condition called adrenal insufficiency).
  • You are currently taking any medicines that suppress or weaken your immune system.
  • You have received a live vaccine (a type of vaccine that uses a weakened form of a virus) within 4 weeks before starting the study treatment.
  • You have received any cancer treatment that works throughout your whole body within 2 weeks before your first dose of the study treatment.
  • You have cancer that has spread to your brain or spinal cord and is causing symptoms, or that requires targeted treatment to that area, or that has needed increasing doses of steroids in the past 2 weeks.
  • You have a current lung inflammation (pneumonitis) or have had lung inflammation caused by a medicine in the past.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Westmead, New South Wales
Novartis Investigative Site, Heidelberg, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
17 June 2015
Est. completion
31 December 2020

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany Hong Kong 🇮🇹 Italy 🇯🇵 Japan 🇸🇬 Singapore 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs); Phase 2: Overall Response Rate (ORR) Per RECIST 1.1

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov