A Phase 2 interventional study of PDR001 and LAG525 in Melanoma, sponsored by Novartis Pharmaceuticals. Completed at 30 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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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 14th largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2018, is one of 10 in phase 2, and was the 29th 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 196 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 primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
This study was a randomized, open-label, two-part, multi-center, open platform phase II study designed to evaluate the efficacy and safety of the anti-PD-1 antibody PDR001 in combination with novel agents for previously treated unresectable or metastatic melanoma. Additionally, a non-randomized single-arm was added based on interim analysis findings to assess the efficacy and safety of PDR001 in combination with LAG525 in subjects with previously treated unresectable or metastatic LAG-3 positive melanoma.
The study consisted of two parts: the selection part and the expansion part, which were applicable to both the randomized and non-randomized sections. In the randomized section, participants were randomized to one of four combination arms available for enrollment:
At each interim analysis, the following determinations were made: (1) which arm met the pre-specified efficacy criteria and expanded to the expansion part, (2) which arms continued enrollment in selection part (up to 45 subjects), and (3) which arms were discontinued due to futility, considering efficacy, safety, and biomarker data. The expansion phase included enrollment of subjects only in the combination arms that met the pre-specified criteria in selection part.
In the non-randomized section, a single combination arm was opened for enrollment in selection part:
Arm 1A would be eligible for enrollment in expansion part only if it met the pre-specified criterion for this arm.
Participants received the study treatment corresponding to their assigned arm on a 28-day cycle basis until disease progression, as determined by local assessment using RECIST v1.1 criteria, or until certain events occurred, such as unacceptable toxicity, initiation of subsequent anti-cancer therapy, withdrawal of consent, investigator's decision, loss to follow-up, death, or termination of the study by the sponsor. Following discontinuation of the study treatment, all subjects were monitored for safety evaluations for up to 150 days after their last dose of the study treatment.
Key inclusion criteria for Arm 1, 2, 3, 4:
Previously treated for unresectable or metastatic melanoma:
A maximum of two for unresectable or metastatic melanoma were allowed.
The last dose of prior therapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4) had to have been received more than four weeks before randomization.
All subjects (with V600BRAF wild-type disease and with V600BRAF mutant disease) had to have documented disease progression as per v1.1 while on/after the last therapy received prior to study entry and while on/after treatment with anti-PD1/PD-L1. The last progression had to have occurred within 12 weeks prior to randomization in the study.
Key inclusion criteria for Arm 1A:
Previously treated for unresectable or metastatic melanoma:
Key exclusion criteria common to all combination arms:
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.
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.
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.
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.
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 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 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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
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.
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.
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.
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 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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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 tumour. 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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participnats randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Drug: PDR001 · Drug: LAG525
Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks
Drug: PDR001 · Drug: INC280
Participants randomized to receive to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Drug: PDR001 · Drug: ACZ885
Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks
Drug: PDR001 · Drug: LEE011
LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks
Drug: PDR001 · Drug: LAG525
400 mg of PDR001 administered every 4 weeks intravenously
Also known as: Spartalizumab
600 mg of LAG525 administered every 4 weeks intravenously
Also known as: Ieramilimab
400 mg of INC280 administered twice daily orally
Also known as: Capmatinib
200 mg of ACZ885 administered every 4 weeks subcutaneosuly
Also known as: Canakinumab
600 mg of LEE011 orally taken once daily on Days 1-21 of a 28-day cycle
Also known as: Ribociclib
Overall Response Rate (ORR)
ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-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 49 months (randomized section) and 18 months (non-randomized section)
Duration of Response (DOR)
DOR defined as the time from date of first documented CR or PR to date of first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. Subjects continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. CR:Disappearance of all non-nodal target and non-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 first documented response to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized part) and 18 months (non-randomized part)
Overall Survival (OS)
OS was defined as the time from date of randomization (or date of first dose of study treatment in non-randomized part) to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method, and the medians and 95% confidence intervals of the medians were presented.
Time frame: From randomization (or start of treatment for non-randomized section) to death due to any cause, assessed up to 49 months (randomized section) and 24 months (non-randomized section)
Progression Free Survival (PFS)
PFS was defined as the time between the date of randomization (or date of first dose of study treatment in non-randomized section) to the date of event defined as the first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. If a subject had not had an event before leaving study or initiation of subsequent anticancer therapy, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using the Kaplan-Meier method, medians and 95% confidence interval of the medians were presented.
Time frame: From randomization (or start of treatment for non-randomized section) to disease progression or death due to any cause, whichever occurs first, assessed up to 49 months (randomized section) and 18 months (non-randomized section)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with best overall response of CR, PR or stable disease (SD) (as per local review by RECIST v1.1 and assessed by CT/MRI). CR:Disappearance of all non-nodal target and non-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 49 months (randomized section) and 18 months (non-randomized section)
Percentage of Participants With PDR001 Anti-drug Antibodies (ADA) Positive Result at Baseline
Percentage of participants who had a PDR001 ADA positive result at baseline.
Time frame: At Baseline
Percentage of Participants With LAG525 Anti-drug Antibodies (ADA) Positive Result at Baseline
Percentage of participants who had a LAG525 ADA positive result at baseline. Only applicable for participants enrolled in Arm 1 and Arm 1A.
Time frame: At Baseline
Percentage of Participants With ACZ885 Anti-drug Antibodies (ADA) Positive Result at Baseline
Percentage of participants who had an ACZ885 ADA positive result at baseline. Only applicable for subjects enrolled in Arm 3.
Time frame: At Baseline
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for PDR001
Percentage of participants who tested positive for treatment-induced ADA for PDR001 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for PDR001 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment).
Time frame: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT), EOT, and 30 and 150 days post-EOT (assessed up to 49 months randomized section and 24 months non-randomized section). Cycle= 28 days
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for LAG525
Percentage of participants who tested positive for treatment-induced ADA for LAG525 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for LAG525 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 1 and Arm 1A.
Time frame: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 49 months in the randomized section and 18 months in the non-randomized section). Cycle= 28 days
Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for ACZ885
Percentage of participants who tested positive for treatment-induced ADA for ACZ885 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for ACZ885 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 3.
Time frame: Pre-infusion on Day 1 of Cycle 1, 2, 3, 4, 5, 6 and thereafter every 3 cycles until end of treatment (EOT) and EOT (assessed up to 40 months). Cycle= 28 days
Percentage of Participants With a Favorable Biomarker Profile (pFBP)
Biomarker parameters included: 1) number of tumor infiltrating T cells (TIL), 2) activation level of TIL, and 3) changes in immune response gene expression signatures. For the number of TILs, an increase in tumoral CD8+ cell numbers compared to baseline was considered favorable. The activation level of TIL was assessed by the percentage of tumoral CD8+ cells expressing GzmB (a marker for cytotoxic activity) or Ki67 (a marker for cell proliferation), where an increase in either GZMB+/CD8+ or KI67+/CD8+ post-baseline was considered favorable. Changes in immune response gene expression signatures were evaluated by the levels in T-cell inflamed signature (TIS), where an increase from baseline was considered favorable. To be categorized as having a pFBP, a subject must meet the favorable criteria for at least two of the three biomarker parameters. The percentage of participants with pFBP was assessed.
Time frame: Baseline and after 3-4 weeks of treatment
None of the arms were opened in the extension part.
| Milestone | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Started | 45 | 43 | 43 | 44 | 21 |
| Treated | 45 | 43 | 42 | 44 | 21 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 45 | 43 | 43 | 44 | 21 |
| Withdrew: Adverse event | 3 | 3 | 5 | 11 | 1 |
| Withdrew: Death | 2 | 2 | 3 | 0 | 1 |
| Withdrew: Physician decision | 6 | 7 | 6 | 3 | 2 |
| Withdrew: Progressive disease | 33 | 28 | 26 | 30 | 16 |
| Withdrew: Subject decision | 1 | 3 | 3 | 0 | 1 |
ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-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 | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | 8.9 (2.5 to 21.2) | 4.7 (0.6 to 15.8) | 4.7 (0.6 to 15.8) | 6.8 (1.4 to 18.7) | 14.3 (3.0 to 36.3) |
DOR defined as the time from date of first documented CR or PR to date of first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. Subjects continuing without progression or death due to underlying cancer were censored at the date of their last adequate tumor assessment. CR:Disappearance of all non-nodal target and non-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.
| Days | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Duration of Response (DOR) | 476 (169 to 1373) | 941.5 (504 to 1379) | 617.5 (113 to 1122) | 217 (169 to 281) | 281 (169 to 449) |
OS was defined as the time from date of randomization (or date of first dose of study treatment in non-randomized part) to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method, and the medians and 95% confidence intervals of the medians were presented.
| Months | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Overall Survival (OS) | 8.8 (6.3 to 21.4) | 12.1 (6.6 to 18.5) | 8.7 (5.7 to 17.9) | 10.1 (7.4 to 15.6) | 14.0 (8.4 to NA) |
PFS was defined as the time between the date of randomization (or date of first dose of study treatment in non-randomized section) to the date of event defined as the first documented disease progression (as per local review by RECIST v1.1 and assessed by CT/MRI) or death due to any cause. If a subject had not had an event before leaving study or initiation of subsequent anticancer therapy, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using the Kaplan-Meier method, medians and 95% confidence interval of the medians were presented.
| Months | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | 2.7 (1.7 to 2.8) | 2.7 (2.4 to 2.8) | 2.7 (2.6 to 2.8) | 2.8 (2.7 to 4.4) | 2.8 (2.7 to 4.6) |
DCR was defined as the percentage of participants with best overall response of CR, PR or stable disease (SD) (as per local review by RECIST v1.1 and assessed by CT/MRI). CR:Disappearance of all non-nodal target and non-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 | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Disease Control Rate (DCR) | 15.6 (6.5 to 29.5) | 16.3 (6.8 to 30.7) | 18.6 (8.4 to 33.4) | 31.8 (18.6 to 47.6) | 33.3 (14.6 to 57.0) |
Percentage of participants who had a PDR001 ADA positive result at baseline.
| Participants | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Percentage of Participants With PDR001 Anti-drug Antibodies (ADA) Positive Result at Baseline | 1 | 0 | 1 | 0 | 0 |
Percentage of participants who had a LAG525 ADA positive result at baseline. Only applicable for participants enrolled in Arm 1 and Arm 1A.
| Participants | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|
| Percentage of Participants With LAG525 Anti-drug Antibodies (ADA) Positive Result at Baseline | 3 | 0 |
Percentage of participants who had an ACZ885 ADA positive result at baseline. Only applicable for subjects enrolled in Arm 3.
| Participants | Arm 3: ACZ885 + PDR001 (Randomized Section) |
|---|---|
| Percentage of Participants With ACZ885 Anti-drug Antibodies (ADA) Positive Result at Baseline | 0 |
Percentage of participants who tested positive for treatment-induced ADA for PDR001 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for PDR001 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment).
| Participants | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for PDR001 | 3 | 5 | 3 | 0 | 0 |
Percentage of participants who tested positive for treatment-induced ADA for LAG525 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for LAG525 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 1 and Arm 1A.
| Participants | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|
| Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for LAG525 | 7 | 2 |
Percentage of participants who tested positive for treatment-induced ADA for ACZ885 (subjects with ADA-negative sample at baseline with at least one post-baseline ADA positive sample) as well as treatment-boosted ADA for ACZ885 (subjects with baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment). Only applicable for subjects enrolled in Arm 3.
| Participants | Arm 3: ACZ885 + PDR001 (Randomized Section) |
|---|---|
| Percentage of Participants Who Were Treatment-induced ADA Positive and Treatment-boosted ADA Positive for ACZ885 | 1 |
Biomarker parameters included: 1) number of tumor infiltrating T cells (TIL), 2) activation level of TIL, and 3) changes in immune response gene expression signatures. For the number of TILs, an increase in tumoral CD8+ cell numbers compared to baseline was considered favorable. The activation level of TIL was assessed by the percentage of tumoral CD8+ cells expressing GzmB (a marker for cytotoxic activity) or Ki67 (a marker for cell proliferation), where an increase in either GZMB+/CD8+ or KI67+/CD8+ post-baseline was considered favorable. Changes in immune response gene expression signatures were evaluated by the levels in T-cell inflamed signature (TIS), where an increase from baseline was considered favorable. To be categorized as having a pFBP, a subject must meet the favorable criteria for at least two of the three biomarker parameters. The percentage of participants with pFBP was assessed.
| Percentage of participants | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Percentage of Participants With a Favorable Biomarker Profile (pFBP) | 13.6 (2.9 to 34.9) | 4.8 (0.1 to 23.8) | 6.5 (0.8 to 21.4) | 16.7 (0.4 to 64.1) | — |
Pre-treatment: deaths collected from day of patient's informed consent to the day before the first administration of study treatment. On-treatment: deaths collected from start of treatment to 30 days after last dose of study treatment. Extended safety follow-up: deaths collected from 31 days after last dose of study treatment up to 150 days after last dose of PDR001 (if this timepoint was later than 30 days after last dose of study treatment) Post-treatment survival follow-up: deaths collected from day 151 post-last dose of PDR001 or 31 days after last dose of study treatment (whichever occurred last) up to end of study.
| Participants | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) |
|---|---|---|---|---|---|
| Pre-treatment deaths | 0 | 0 | 0 | 0 | 0 |
| On-treatment deaths | 5 | 3 | 3 | 3 | 1 |
| Extended safety follow-up deaths | 14 | 11 | 15 | 11 | 4 |
| Post-treatment survival follow-up deaths | 18 | 19 | 15 | 19 | 7 |
| All deaths | 37 | 33 | 33 | 33 | 12 |
Collected over On-treatment: from first dose to 30 days post-treatment, up to 49/24 months (randomized/non-randomized) Extended safety follow-up: from 31 days after last dose of treatment up to 150 days after last dose of PDR001 (if >30 days post-treatment), up to 49/24 months (randomized/non-randomized) Post-treatment survival follow-up: from day 151 after last dose of PDR001 or 31 days post-treatment (whichever occurred last) up to end of study, up to 49/24 months (randomized/non-randomized).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period | 5/45 (11.1%) | 21/45 (46.7%) | 40/45 (88.9%) |
| Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up | 14/45 (31.1%) | 5/45 (11.1%) | 5/45 (11.1%) |
| Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | 18/26 (69.2%) | — | — |
| Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period | 3/43 (7%) | 21/43 (48.8%) | 42/43 (97.7%) |
| Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up | 11/43 (25.6%) | 0/43 (0%) | 6/43 (14%) |
| Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up | 19/29 (65.5%) | — | — |
| Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period | 3/42 (7.1%) | 12/42 (28.6%) | 32/42 (76.2%) |
| Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up | 15/42 (35.7%) | 4/42 (9.5%) | 5/42 (11.9%) |
| Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | 15/24 (62.5%) | — | — |
| Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period | 3/44 (6.8%) | 22/44 (50%) | 44/44 (100%) |
| Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up | 11/44 (25%) | 8/44 (18.2%) | 9/44 (20.5%) |
| Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | 19/30 (63.3%) | — | — |
| Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period | 1/21 (4.8%) | 7/21 (33.3%) | 18/21 (85.7%) |
| Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up | 4/21 (19%) | 2/21 (9.5%) | 2/21 (9.5%) |
| Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up | 7/14 (50%) | — | — |
| Event | Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period | Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up | Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period | Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up | Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period | Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up | Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period | Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up | Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period | Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up | Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pathological fractureMusculoskeletal and connective tissue disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 2/21 | 0/21 | — |
| Hypercalcaemia of malignancyEndocrine disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 0/21 | 1/21 | — |
| DysphagiaGastrointestinal disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 1/21 | 0/21 | — |
| Immune-mediated enterocolitisGastrointestinal disorders | 0/45 | 1/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 1/21 | 0/21 | — |
| Small intestinal obstructionGastrointestinal disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 1/21 | 0/21 | — |
| SubileusGastrointestinal disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 1/21 | 0/21 | — |
| HyponatraemiaMetabolism and nutrition disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 0/21 | 1/21 | — |
| Oncologic complicationNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 0/44 | 0/44 | — | 1/21 | 0/21 | — |
| Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/45 | 1/45 | — | 1/43 | 0/43 | — | 2/42 | 0/42 | — | 1/44 | 0/44 | — | 0/21 | 0/21 | — |
| Spinal cord compressionNervous system disorders | 0/45 | 0/45 | — | 0/43 | 0/43 | — | 0/42 | 0/42 | — | 1/44 | 0/44 | — | 1/21 | 0/21 | — |
| Event | Arm 1: LAG525 + PDR001 (Randomized Part)- On-treatment Period | Arm 1: LAG525 + PDR001 (Randomized Part)- Extended Safety Follow-up | Arm 1: LAG525 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 2: INC280+PDR001 (Randomized Part)- On-treatment Period | Arm 2: INC280+PDR001 (Randomized Part) - Extended Safety Follow-up | Arm 2: INC280+PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 3: ACZ885 + PDR001 (Randomized Part)- On-treatment Period | Arm 3: ACZ885 + PDR001 (Randomized Part)- Extended Safety Follow-up | Arm 3: ACZ885 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 4: LEE011 + PDR001 (Randomized Part)- On-treatment Period | Arm 4: LEE011 + PDR001 (Randomized Part)- Extended Safety Follow-up | Arm 4: LEE011 + PDR001 (Randomized Part)- Post-treatment Survival Follow-up | Arm 1A: LAG525 + PDR001 (Non-randomized Part)- On-treatment Period | Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Extended Safety Follow-up | Arm 1A: LAG525 + PDR001 (Non-randomized Part)- Post-treatment Survival Follow-up |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 3/45 | 1/45 | — | 0/43 | 0/43 | — | 1/42 | 0/42 | — | 20/44 | 0/44 | — | 0/21 | 0/21 | — |
| NauseaGastrointestinal disorders | 13/45 | 0/45 | — | 18/43 | 0/43 | — | 9/42 | 1/42 | — | 15/44 | 2/44 | — | 6/21 | 0/21 | — |
| Aspartate aminotransferase increasedInvestigations | 1/45 | 0/45 | — | 5/43 | 0/43 | — | 3/42 | 0/42 | — | 17/44 | 1/44 | — | 1/21 | 0/21 | — |
| Alanine aminotransferase increasedInvestigations | 1/45 | 0/45 | — | 6/43 | 0/43 | — | 2/42 | 1/42 | — | 15/44 | 2/44 | — | 1/21 | 0/21 | — |
| AstheniaGeneral disorders | 9/45 | 1/45 | — | 7/43 | 1/43 | — | 7/42 | 0/42 | — | 8/44 | 2/44 | — | 7/21 | 0/21 | — |
| PyrexiaGeneral disorders | 3/45 | 0/45 | — | 13/43 | 0/43 | — | 2/42 | 0/42 | — | 8/44 | 2/44 | — | 2/21 | 0/21 | — |
| VomitingGastrointestinal disorders | 6/45 | 0/45 | — | 11/43 | 0/43 | — | 3/42 | 0/42 | — | 8/44 | 1/44 | — | 3/21 | 0/21 | — |
| AnaemiaBlood and lymphatic system disorders | 3/45 | 2/45 | — | 6/43 | 1/43 | — | 6/42 | 1/42 | — | 11/44 | 0/44 | — | 3/21 | 1/21 | — |
| PruritusSkin and subcutaneous tissue disorders | 11/45 | 0/45 | — | 6/43 | 0/43 | — | 3/42 | 0/42 | — | 8/44 | 1/44 | — | 3/21 | 0/21 | — |
| DiarrhoeaGastrointestinal disorders | 6/45 | 0/45 | — | 10/43 | 1/43 | — | 3/42 | 0/42 | — | 9/44 | 1/44 | — | 5/21 | 0/21 | — |
| Age, Categorical(Participants) | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 29 | 28 | 28 | 8 | 122 |
| >=65 years | 16 | 14 | 15 | 16 | 13 | 74 |
| Sex: Female, Male(Participants) | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) | Total |
|---|---|---|---|---|---|---|
| Female | 17 | 21 | 15 | 14 | 9 | 76 |
| Male | 28 | 22 | 28 | 30 | 12 | 120 |
| Race (NIH/OMB)(Participants) | Arm 1: LAG525 + PDR001 (Randomized Section) | Arm 2: INC280+PDR001 (Randomized Section) | Arm 3: ACZ885 + PDR001 (Randomized Section) | Arm 4: LEE011 + PDR001 (Randomized Section) | Arm 1A: LAG525 + PDR001 (Non-randomized Section) | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 45 | 42 | 38 | 42 | 20 | 187 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 4 | 2 | 0 | 7 |
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 Sep 2018 to primary completion in Dec 2022, 51 months.
Results were first posted in Jan 2024, 1 year after primary completion.
Of 106 industry-sponsored phase 2 interventional studies under Melanoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 60. This study's 51 months is above that.
Counting every sponsor, half of 384 studies reached it within 53 months; a quarter within 32 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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