A Phase 2 interventional study of LAG525 and PDR001 in Triple-negative Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 33 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 22 studies in Triple Negative Breast Neoplasms by Novartis — 4 open to participants now, 6 under way, none of them phase 3. Triple Negative Breast Neoplasms · Novartis.
Among the 22 studies in Triple Negative Breast Neoplasms by Novartis, this one is the 16th largest by enrollment, is one of 2 that started in 2018, is one of 5 in phase 2, and was the 12th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →4 of the 22 studies in Triple Negative Breast Neoplasms by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Australia, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in Denmark, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Canada, Denmark and 4 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Belgium, Canada and 7 more countries
Ages 18–100
By country, each count listing its studies:
Of the 331 Triple Negative Breast Neoplasms studies recruiting now, 231 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 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.
22 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 16 · Phase 2 7 · Phase 3 1
First in 2010; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 88 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 132 across the 22 interventional studies. Of the 15 that completed or were terminated, 7 (47%) 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.
2 of the studies in Triple Negative Breast Neoplasms 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 |
|---|---|
| NCT03891953Novartis PharmaceuticalsStudy of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. | 2027-06-25 |
| 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 2 to your calendar (.ics) → With an account.
Among the 22 studies in Triple Negative Breast Neoplasms by Novartis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The main purpose of this study was to assess the antitumor activity of three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in participants with advanced triple-negative breast cancer (TNBC) in first or second line therapy.
This was an open-label, Phase II, randomized, multicenter study to assess the efficacy, safety, and pharmacokinetic characteristics of the following three combinations: LAG525 + spartalizumab (PDR001) (Arm 1), LAG525 + spartalizumab (PDR001) + carboplatin (Arm 2), and LAG525 + carboplatin (Arm 3) in participants with advanced triple-negative breast cancer (TNBC) which progressed after adjuvant or one prior line of systemic therapy for metastatic disease.
Participants were assigned to one of the three treatment arms in a ratio of 1:1:1. In protocol amendment 3 (released on 28-Mar-2019), enrollment to treatment Arm 1 (LAG525 + spartalizumab) was prematurely closed due to a higher discontinuation rate due to progressive disease and all subsequent enrolled patients were randomized to Arms 2 and 3 only, in a ratio of 1:1.
Study treatment continued until disease progression, unacceptable toxicity, pregnancy, investigator/participant decision, start of a new anti-neoplastic therapy, withdrawal of consent, lost to follow-up, death, or study was terminated by the sponsor. The investigator might decide to stop carboplatin after 6 cycles, even if the above criteria were not met. Participants who continued to derive clinical benefit from the treatment based on the investigator's evaluation following their completion of this trial might receive post-trial access (PTA) i.e. rollover protocol or a post-study drug supply (PSDS).
The end of study was defined as the earliest occurrence of one of the following: (1) all participants had died or (2) discontinued from the study, or (3) another clinical study became available that could continue to provide study treatment in this participant population and all ongoing participants were eligible to be transferred to that clinical study.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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 tumor 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 tumor visible on a scan does not by itself rule you out.
The standard rules for measuring tumors 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 tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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 tumor sample. Some scores count stained tumor cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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 tumor 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 tumor 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 tumors 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 tumor 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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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 tumor sample. Some scores count stained tumor 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.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received LAG525 and PDR001 administered as infusion once every 3 weeks
Drug: LAG525 · Drug: PDR001
Participants received LAG525, PDR001 and carboplatin administered as infusion once every 3 weeks.
Drug: LAG525 · Drug: PDR001 · Drug: Carboplatin
Participants received LAG525 and carboplatin administered as infusion once every 3 weeks
Drug: LAG525 · Drug: Carboplatin
LAG525 was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 400mg every 21 days. For all arms, LAG525 was infused first
Spartalizumab was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 300mg every 21 days. Spartalizumab was infused after LAG525
Also known as: Spartalizumab
Carboplatin was a concentrate for solution for intravenous infusion, came in 100mg/mL and was dosed per area under the curve (AUC) 6 every 21 days. Carboplatin was infused once LAG525 and spartalizumab infusions were completed
Overall Response Rate (ORR) Per Investigator's Assessment According to RECIST v1.1
Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 14 months
Clinical Benefit Rate (CBR) Per Investigator's Assessment According to RECIST v1.1
CBR is defined as the percentage of participants with a best overall response (BOR) of confirmed CR or PR, or stable disease (SD) lasting 24 weeks or longer, according to RECIST 1.1 criteria. The 95% CI were computed using two-sided exact binomial method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time frame: Up to approximately 14 months
Duration of Response (DOR) Per Investigator's Assessment According to RECIST v1.1
DOR is the time between the first documented response (CR or PR) and the first documented progression or death due to underlying cancer based on RECIST1.1 and as per investigator's assessment. The DOR distribution was estimated using the Kaplan-Meier method and the 95% confidence intervals using the method of Brookmeyer and Crowley. If progression or death did not occur, the participant was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progression: at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. The sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From first documented response up to disease progression or death due to underlying cancer, whichever occurs first, up to approximately 14 months
Time to Response (TTR) Per Investigator's Assessment According to RECIST v1.1
TTR is the time from date of randomization to first documented response of CR or PR based on investigators' assessment and according to RECIST 1.1. Median TTR was summarized using descriptive statistics. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: From date of randomization to first documented response (CR or PR), up to approximately 14 months
Progression Free Survival (PFS)
PFS is defined as time from date of randomization to the date of first documented progression or death due to any cause. PFS was assessed via investigator's assessment according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed prior to the analysis cut-off date or before the start of the new anticancer therapy date, whichever is earlier. The PFS distribution was estimated using the Kaplan-Meier method. The 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.
Time frame: From date of randomization to disease progression or death due to any cause, whichever occurs first, up to approximately 14 months
Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date). The OS distribution was estimated using the Kaplan-Meier method. The 95% confidence intervals were calculated using the method of Brookmeyer and Crowley
Time frame: From date of randomization to date of death due to any cause, up to 18 months
Pharmacokinetics (PK) Parameter, Area Under the Plasma Concentration Versus Time Curve From Time 0 to 504 Hours (AUC0-504h) of LAG525
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-504h was defined as the area under the plasma concentration-time curve from time zero to 504h.
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, Cmax of LAG525
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed plasma LAG525 concentration
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, AUClast of LAG525
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of LAG525
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, Tmax of LAG525
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum LAG525 serum concentration. Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, AUC0-504h of PDR001
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-504h was defined as the area under the plasma concentration-time curve from time zero to 504h.
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, Cmax of PDR001
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed PDR001 serum concentration
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, AUClast of PDR001
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of PDR001
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, Tmax of PDR001
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum PDR001 serum concentration. Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
Time frame: Cycle 1 at pre-infusion, 1 hour (hr) post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 1. Cycle 3 at pre-infusion, 1 hr post end of infusion, 168 hr, 336 hr and 504 hr post-infusion on Day 1 of Cycle 3. Each cycle is 21 days
PK Parameter, AUC0-4h of Carboplatin (Total Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-4h was defined as the area under the plasma concentration-time curve from time zero to 4h (determined as total platinum).
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, Cmax of Carboplatin (Total Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed carboplatin plasma concentration (determined as total platinum)
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, AUClast of Carboplatin (Total Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of carboplatin (determined as total platinum)
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, Tmax of Carboplatin (Total Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum carboplatin plasma concentration (determined as total platinum). Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, AUC0-4h of Carboplatin (Ultrafilterable Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-4h was defined as the area under the plasma concentration-time curve from time zero to 4h (determined as ultrafilterable platinum).
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, Cmax of Carboplatin (Ultrafilterable Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed carboplatin plasma concentration (determined as ultrafilterable platinum)
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, AUClast of Carboplatin (Ultrafilterable Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of carboplatin (determined as ultrafilterable platinum)
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
PK Parameter, Tmax of Carboplatin (Ultrafilterable Platinum)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum carboplatin plasma concentration (determined as ultrafilterable platinum). Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
Time frame: Cycle 1 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Cycle 3 at pre-infusion, end of infusion, 1 hour, 2 hours and 3 hours post end of infusion. Each cycle is 21 days
Number of Participants With Anti-drug Antibodies (ADA) at Baseline for LAG525
Number of participants who had an ADA positive result at baseline for LAG525
Time frame: Baseline
Number of Participants With Anti-drug Antibodies (ADA) on Treatment for LAG525
Number of participants who were treatment-induced ADA positive for LAG525 (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive for LAG525 (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
Time frame: From Cycle 1 to Cycle 7 (Day 1 pre-infusion) and end of treatment, assessed up to 3 years
Number of Participants With Anti-drug Antibodies (ADA) at Baseline for PDR001
Number of participants who had an ADA positive result at baseline for PDR001.
Time frame: Baseline
Number of Participants With Anti-drug Antibodies (ADA) on Treatment for PDR001
Number of participants who were treatment-induced ADA positive for PDR001 (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive for PDR001 (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
Time frame: From Cycle 1 to Cycle 7 (Day 1 pre-infusion) and end of treatment, assessed up to 2.8 years
The study was conducted across 33 centers in 17 countries.
| Milestone | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Started | 20 | 34 | 34 |
| Treated | 19 | 34 | 34 |
| Completed | 0 | 0 | 0 |
| Not completed | 20 | 34 | 34 |
| Withdrew: Adverse event | 2 | 3 | 3 |
| Withdrew: Death | 0 | 0 | 1 |
| Withdrew: Physician decision | 3 | 6 | 6 |
| Withdrew: Progressive disease | 15 | 23 | 23 |
| Withdrew: Patient decision | 0 | 1 | 1 |
| Withdrew: Terminated by sponsor (end of study definition was met) | 0 | 1 | 0 |
Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| Percentage of participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Overall Response Rate (ORR) Per Investigator's Assessment According to RECIST v1.1 | 5.0 (0.1 to 24.9) | 32.4 (17.4 to 50.5) | 17.6 (6.8 to 34.5) |
CBR is defined as the percentage of participants with a best overall response (BOR) of confirmed CR or PR, or stable disease (SD) lasting 24 weeks or longer, according to RECIST 1.1 criteria. The 95% CI were computed using two-sided exact binomial method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
| Percentage of Participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Clinical Benefit Rate (CBR) Per Investigator's Assessment According to RECIST v1.1 | 5.0 (0.1 to 24.9) | 35.3 (19.7 to 53.5) | 20.6 (8.7 to 37.9) |
DOR is the time between the first documented response (CR or PR) and the first documented progression or death due to underlying cancer based on RECIST1.1 and as per investigator's assessment. The DOR distribution was estimated using the Kaplan-Meier method and the 95% confidence intervals using the method of Brookmeyer and Crowley. If progression or death did not occur, the participant was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target lesions and any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progression: at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. The sum must also demonstrate an absolute increase of at least 5 mm.
| Months | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Duration of Response (DOR) Per Investigator's Assessment According to RECIST v1.1 | 4.9 (NA to NA) | 13.6 (2.8 to NA) | 12.6 (2.4 to NA) |
TTR is the time from date of randomization to first documented response of CR or PR based on investigators' assessment and according to RECIST 1.1. Median TTR was summarized using descriptive statistics. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| Months | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Time to Response (TTR) Per Investigator's Assessment According to RECIST v1.1 | 1.5 (1.5 to 1.5) | 1.7 (1.2 to 4.1) | 1.4 (1.2 to 2.8) |
PFS is defined as time from date of randomization to the date of first documented progression or death due to any cause. PFS was assessed via investigator's assessment according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed prior to the analysis cut-off date or before the start of the new anticancer therapy date, whichever is earlier. The PFS distribution was estimated using the Kaplan-Meier method. The 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.
| Months | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Progression Free Survival (PFS) | 1.4 (1.2 to 1.5) | 4.3 (2.8 to 5.6) | 3.0 (2.2 to 5.5) |
OS is defined as the time from date of randomization to date of death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date). The OS distribution was estimated using the Kaplan-Meier method. The 95% confidence intervals were calculated using the method of Brookmeyer and Crowley
| Months | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Overall Survival (OS) | 6.1 (4.6 to NA) | 11.6 (7.5 to NA) | 8.0 (6.2 to 9.3) |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-504h was defined as the area under the plasma concentration-time curve from time zero to 504h.
| day*microgram/miliLiter (day*ug/mL) | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Cycle 1 | 1270 ± 25.8 | 1350 ± 22.4 | 1180 ± 23.4 |
| Cycle 3 | 2060 ± 60.1 | 2200 ± 34.4 | 1990 ± 31.3 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed plasma LAG525 concentration
| ug/mL | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Cycle 1 | 127 ± 26.5 | 136 ± 21.1 | 128 ± 17.9 |
| Cycle 3 | 144 ± 48.9 | 181 ± 29.5 | 168 ± 26.6 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of LAG525
| day*ug/mL | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Cycle 1 | 1170 ± 32.0 | 1310 ± 41.1 | 1010 ± 151.2 |
| Cycle 3 | 240 ± 9775.4 | 2040 ± 49.8 | 1490 ± 196.4 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum LAG525 serum concentration. Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
| hr | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Cycle 1 | 1.51 ± 40.7 | 1.76 ± 35.5 | 1.58 ± 23.1 |
| Cycle 3 | 1.64 ± 13.4 | 1.58 ± 15.0 | 1.77 ± 37.4 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-504h was defined as the area under the plasma concentration-time curve from time zero to 504h.
| day*ug/mL | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin |
|---|---|---|
| Cycle 1 | 819 ± 23.6 | 907 ± 29.1 |
| Cycle 3 | 1490 ± 41.0 | 1710 ± 29.5 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed PDR001 serum concentration
| ug/mL | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin |
|---|---|---|
| Cycle 1 | 78.0 ± 18.9 | 82.4 ± 25.1 |
| Cycle 3 | 95.1 ± 41.4 | 117 ± 26.8 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of PDR001
| day*ug/mL | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin |
|---|---|---|
| Cycle 1 | 780 ± 24.4 | 890 ± 44.6 |
| Cycle 3 | 374 ± 2703.2 | 1500 ± 55.7 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum PDR001 serum concentration. Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
| hr | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin |
|---|---|---|
| Cycle 1 | 1.43 ± 34.7 | 1.71 ± 29.7 |
| Cycle 3 | 1.67 ± 13.6 | 1.61 ± 13.9 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-4h was defined as the area under the plasma concentration-time curve from time zero to 4h (determined as total platinum).
| hour*nanogram/miliLiter (hr*ng/mL) | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 45000 ± 23.0 | 45200 ± 16.1 |
| Cycle 3 | 42700 ± 27.6 | 43500 ± 29.2 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed carboplatin plasma concentration (determined as total platinum)
| ng/mL | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 22300 ± 32.0 | 21400 ± 32.2 |
| Cycle 3 | 20900 ± 33.4 | 20000 ± 199.2 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of carboplatin (determined as total platinum)
| ng/mL | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 42000 ± 30.8 | 38900 ± 56.3 |
| Cycle 3 | 40800 ± 38.1 | 42600 ± 43.3 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum carboplatin plasma concentration (determined as total platinum). Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
| hr | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 0.857 ± 35.5 | 0.720 ± 31.9 |
| Cycle 3 | 0.789 ± 33.0 | 0.720 ± 34.8 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUC0-4h was defined as the area under the plasma concentration-time curve from time zero to 4h (determined as ultrafilterable platinum).
| hour*nanogram/miliLiter (hr*ng/mL) | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 43600 ± 13.1 | 44700 ± 23.4 |
| Cycle 3 | 41100 ± 30.5 | 41000 ± 12.8 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Cmax is the maximum observed carboplatin plasma concentration (determined as ultrafilterable platinum)
| ng/mL | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 23200 ± 19.8 | 25700 ± 24.2 |
| Cycle 3 | 22300 ± 40.1 | 14700 ± 4159.6 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. AUClast is the area under the curve (AUC) from time zero to the last measurable concentration sampling time (tlast) of carboplatin (determined as ultrafilterable platinum)
| ng/mL | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 41400 ± 13.0 | 35600 ± 65.2 |
| Cycle 3 | 37400 ± 30.1 | 36300 ± 68.2 |
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis. Tmax is the time to reach maximum carboplatin plasma concentration (determined as ultrafilterable platinum). Actual time of sample collection was used (not the nominal time point as per scheduled assessment)
| hr | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|
| Cycle 1 | 0.802 ± 42.5 | 0.660 ± 34.4 |
| Cycle 3 | 0.828 ± 39.7 | 0.686 ± 34.6 |
Number of participants who had an ADA positive result at baseline for LAG525
| Participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA) at Baseline for LAG525 | 0 | 0 | 1 |
Number of participants who were treatment-induced ADA positive for LAG525 (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive for LAG525 (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
| Participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA) on Treatment for LAG525 | 0 | 0 | 1 |
Number of participants who had an ADA positive result at baseline for PDR001.
| Participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin |
|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA) at Baseline for PDR001 | 3 | 6 |
Number of participants who were treatment-induced ADA positive for PDR001 (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive for PDR001 (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
| Participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin |
|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADA) on Treatment for PDR001 | 1 | 0 |
On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication for a maximum duration of 2.9 years. Extended safety follow up deaths were collected from day 31 post treatment up to 150 days post-treatment, for a maximum duration of 3.2 years. Post-treatment deaths were collected after 150 days post-treatment, for a maximum duration of 3.2 years.
| Participants | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin |
|---|---|---|---|
| On-treatment | 0 | 2 | 1 |
| Extended safety follow-up deaths | 7 | 7 | 16 |
| Post-treatment deaths | 8 | 15 | 11 |
| All deaths | 15 | 24 | 28 |
Collected over In the on-treatment period, adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to 2.9 years In the extended safety follow-up period, AEs and serious AEs (including the All-Cause Mortality data table) are presented from day 31 to day 150 after last administration of study treatment, up to 3.2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LAG525 + PDR001 (On-treatment Period) | 0/19 (0%) | 6/19 (31.6%) | 17/19 (89.5%) |
| LAG525 + PDR001 (Extended Safety Follow-up Period) | 7/19 (36.8%) | 0/19 (0%) | 0/19 (0%) |
| LAG525 + PDR001+Carboplatin (On-treatment Period) | 2/34 (5.9%) | 12/34 (35.3%) | 34/34 (100%) |
| LAG525 + PDR001+Carboplatin (Extended Safety Follow-up Period) | 7/34 (20.6%) | 6/34 (17.6%) | 11/34 (32.4%) |
| LAG525 +Carboplatin (On-treatment Period) | 1/34 (2.9%) | 14/34 (41.2%) | 33/34 (97.1%) |
| LAG525 +Carboplatin (Extended Safety Follow-up Period) | 16/34 (47.1%) | 2/34 (5.9%) | 3/34 (8.8%) |
| Event | LAG525 + PDR001 (On-treatment Period) | LAG525 + PDR001 (Extended Safety Follow-up Period) | LAG525 + PDR001+Carboplatin (On-treatment Period) | LAG525 + PDR001+Carboplatin (Extended Safety Follow-up Period) | LAG525 +Carboplatin (On-treatment Period) | LAG525 +Carboplatin (Extended Safety Follow-up Period) |
|---|---|---|---|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/19 | 0/19 | 2/34 | 0/34 | 3/34 | 1/34 |
| AnaemiaBlood and lymphatic system disorders | 0/19 | 0/19 | 0/34 | 0/34 | 2/34 | 1/34 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/19 | 0/19 | 1/34 | 0/34 | 2/34 | 0/34 |
| Fanconi syndromeCongenital, familial and genetic disorders | 1/19 | 0/19 | 0/34 | 0/34 | 0/34 | 0/34 |
| Disease progressionGeneral disorders | 1/19 | 0/19 | 0/34 | 1/34 | 0/34 | 0/34 |
| Pneumocystis jirovecii pneumoniaInfections and infestations | 1/19 | 0/19 | 0/34 | 0/34 | 0/34 | 0/34 |
| PneumoniaInfections and infestations | 1/19 | 0/19 | 0/34 | 0/34 | 0/34 | 0/34 |
| Septic shockInfections and infestations | 1/19 | 0/19 | 0/34 | 0/34 | 0/34 | 0/34 |
| Subcutaneous abscessInfections and infestations | 1/19 | 0/19 | 0/34 | 0/34 | 0/34 | 0/34 |
| Platelet count decreasedInvestigations | 1/19 | 0/19 | 0/34 | 0/34 | 0/34 | 0/34 |
| Event | LAG525 + PDR001 (On-treatment Period) | LAG525 + PDR001 (Extended Safety Follow-up Period) | LAG525 + PDR001+Carboplatin (On-treatment Period) | LAG525 + PDR001+Carboplatin (Extended Safety Follow-up Period) | LAG525 +Carboplatin (On-treatment Period) | LAG525 +Carboplatin (Extended Safety Follow-up Period) |
|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/19 | 0/19 | 20/34 | 5/34 | 19/34 | 1/34 |
| NauseaGastrointestinal disorders | 3/19 | 0/19 | 18/34 | 2/34 | 13/34 | 1/34 |
| ConstipationGastrointestinal disorders | 3/19 | 0/19 | 7/34 | 1/34 | 16/34 | 0/34 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/19 | 0/19 | 15/34 | 0/34 | 14/34 | 1/34 |
| Platelet count decreasedInvestigations | 1/19 | 0/19 | 14/34 | 2/34 | 9/34 | 0/34 |
| FatigueGeneral disorders | 2/19 | 0/19 | 11/34 | 1/34 | 12/34 | 0/34 |
| AstheniaGeneral disorders | 0/19 | 0/19 | 11/34 | 0/34 | 5/34 | 0/34 |
| Neutrophil count decreasedInvestigations | 0/19 | 0/19 | 11/34 | 2/34 | 6/34 | 0/34 |
| NeutropeniaBlood and lymphatic system disorders | 0/19 | 0/19 | 9/34 | 1/34 | 7/34 | 0/34 |
| HeadacheNervous system disorders | 2/19 | 0/19 | 8/34 | 0/34 | 4/34 | 1/34 |
| Age, Continuous(Years) | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin | Total |
|---|---|---|---|---|
| Mean | 53.8 ± 10.22 | 50.9 ± 10.88 | 53.3 ± 10.78 | 52.5 ± 10.65 |
| Sex: Female, Male(Participants) | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin | Total |
|---|---|---|---|---|
| Female | 20 | 34 | 34 | 88 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | LAG525 + PDR001 | LAG525+ PDR001+ Carboplatin | LAG525 + Carboplatin | Total |
|---|---|---|---|---|
| Asian | 8 | 8 | 7 | 23 |
| Black or African American | 0 | 0 | 1 | 1 |
| Missing | 0 | 3 | 1 | 4 |
| White | 12 | 23 | 25 | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Ran from Jul 2018 to primary completion in Feb 2020, 19 months.
Results were first posted in May 2022, 2 years 2 months after primary completion. A results delay was requested in Apr 2020.
Of 255 phase 2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 94. This study's 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. 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.
Studies of the drug tested here: Spartalizumab
Triple Negative Breast Neoplasms →