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 (NCT03484923) enrolled 196 people across five treatment groups. Four groups were part of a randomised section — meaning participants were assigned to a treatment combination by chance — and one group was non-randomised. The five combinations tested all included a drug called PDR001, paired with one of four other drugs: LAG525, INC280, ACZ885, or LEE011. The trial's main goal was to measure the "overall response rate" — that is, the proportion of participants whose tumours shrank significantly or disappeared entirely during treatment. The reported data shows that, for the primary measure (overall response rate), the percentages of participants whose tumours shrank or disappeared were: 8.9% in the LAG525 + PDR001 randomised group, 4.7% in the INC280 + PDR001 group, 4.7% in the ACZ885 + PDR001 group, 6.8% in the LEE011 + PDR001 group, and 14.3% in the non-randomised LAG525 + PDR001 group. For secondary measures, the reported median time participants lived overall (overall survival) ranged from approximately 8.7 to 14.0 months across the five groups. The median time before the disease progressed or death occurred (progression-free survival) was reported as approximately 2.7 to 2.8 months across all groups. The "disease control rate" — the proportion of participants whose disease either shrank or stayed stable — ranged from about 15.6% to 33.3% depending on the group. The reported data also shows that, among participants who did have a measurable response, the length of time that response lasted (duration of response) ranged from a median of 217 days in the LEE011 + PDR001 group up to 941.5 days in the INC280 + PDR001 group, though it is worth noting these figures are based only on the smaller number of participants in each group who had a recorded response. Notably, the data shows zero participants were recorded as having "completed" the study in any group, meaning all participants either left the study early or were still being followed when data was collected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
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 Melanoma Trial, Completed
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:
- You have been diagnosed with melanoma (a type of skin cancer) that has spread or cannot be removed by surgery, and it has been confirmed by a tissue sample (biopsy).
- Your melanoma is classified as an advanced stage (stage IIIB, IIIC, IIID, or IV) using a standard medical staging system.
- You have already received certain previous cancer treatments — the exact treatments required depend on whether your melanoma has a specific gene change called a "BRAF V600 mutation" (confirm with trial site for your specific treatment history requirements).
- If you do not have the BRAF V600 mutation, you must have had no more than 2 previous treatments for your advanced melanoma.
- If you do have the BRAF V600 mutation, you must have had no more than 3 previous treatments for your advanced melanoma.
- Your cancer must have gotten worse (progressed) during or after your last treatment, and this must have happened within the 12 weeks before joining the study.
- Your last cancer treatment must have been finished at least 2–4 weeks before joining the study, depending on which treatment you received (confirm exact timeframe with trial site).
- You must be well enough to carry out some daily activities — rated on a standard scale (called ECOG performance status 0–2, or 0–1 for one part of the trial).
- You must have at least one area of cancer that can be measured on a scan.
- You must have at least one area of cancer that can be safely biopsied (sampled with a needle) more than once during the study.
- Your biopsy sample must meet certain quality standards assessed by a local specialist (confirm details with trial site).
- For one specific part of the trial (Arm 1A), your last treatment before joining must have been a specific type of immunotherapy called an anti-PD-1 drug (pembrolizumab or nivolumab), either alone or combined with ipilimumab.
- For one specific part of the trial (Arm 1A), your tumor sample must test positive for a protein called LAG-3, as confirmed by a central laboratory.
Who may not be able to join:
- Your melanoma started in the eye (uveal melanoma) or in the mucous membranes inside the body (mucosal melanoma).
- You currently have active or unstable cancer that has spread to the brain.
- You have received a live vaccine (such as for flu, shingles, or yellow fever) within the 3 months before joining the study.
- You currently have an active infection that requires antibiotic treatment taken by mouth or through a drip.
- You are currently taking high-dose steroid tablets or other medicines that suppress the immune system (above a certain dose) within 14 days of joining — though some inhaled or skin-applied steroids may be allowed (confirm with trial site).
- You have an active autoimmune disease (where the immune system attacks your own body) or a documented history of one.
- You have previously had a bone marrow transplant or an organ transplant from another person.
- You have had a severe allergic reaction to any of the drugs used in this study.
- You currently have or have had another type of cancer (other than the melanoma being treated in this study).
- You have previously received other types of cancer treatments for your advanced melanoma beyond those specifically allowed in this trial (confirm with trial site).
- You received treatment before or after surgery for melanoma (neoadjuvant or adjuvant therapy) that finished less than 6 months before starting the study.
- You have a history of, or have currently been diagnosed with, a heart muscle condition called myocarditis.
- Your blood test shows that a heart-related protein called Troponin is more than twice the upper limit of the normal range at the time of screening.
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.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Overall Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.