ClinicalTrials.gg
TerminatedNCT02723006Updated Mar 5, 2024Results posted

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma

A Phase 1 interventional study of TAK-580 and TAK-202 in Melanoma, sponsored by Millennium Pharmaceuticals, Inc.. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Millennium Pharmaceuticals, Inc. (part of Takeda) · Phase 1, Interventional, and Other

Why this study was terminated
Business decision: Protocol efficacy futility met
Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the initial safety profile and initial antitumor activity of the combination treatments (immune checkpoint inhibitors [nivolumab, ipilimumab] with investigational drugs [TAK-580, TAK-202 (plozalizumab), vedolizumab]) in the 3 arms when administered to participants with advanced melanoma.

Read the detailed description

The drugs being tested in this study are called TAK-580, TAK-202 (plozalizumab), and vedolizumab. These investigational drugs were given along with standard of care checkpoint inhibitors ([nivolumab in Arms 1 and 2] or nivolumab + ipilimumab in Arm 3). This study looked at the safety profile of the combination treatments in each arm when administered to participants with metastatic melanoma.

The study planned to enroll approximately 156 participants. Participants were assigned to one of the 3 treatment groups:

  • TAK-580 + nivolumab
  • TAK-202 (plozalizumab) + nivolumab
  • vedolizumab + nivolumab + ipilimumab

This study consists of 3 parts. A dose-escalation safety lead-in phase, confirmatory safety phase and a cohort expansion phase. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 50 weeks. Participants may make multiple visits to the clinic and 30, 60, and 90 days after last dose of study drug for follow-up assessments.

02

Conditions studied

  • Melanoma

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Keywords

  • Drug Therapy
03

In context

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's enrollment of 22 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Millennium Pharmaceuticals, Inc. is the lead sponsor of 178 studies on the registry; none are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 73 (99%) have results posted.

First submitted after Millennium Pharmaceuticals, Inc. became part of Takeda.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Is a male or female participant of 18 years or older.
  2. Has confirmed, unresectable Stage III or Stage IV melanoma per the American Joint Committee on Cancer (AJCC) staging system.
  3. Has an (ECOG) performance status of 0-1.
  4. Adequate bone marrow reserve and renal and hepatic function within 28 days before the first dose of study drug on the basis of the defined laboratory parameters.
  5. For TAK-580 + nivolumab and TAK-202 (plozalizumab) + nivolumab only: Had disease accessible for repeat nonsignificant risk (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures extending beyond the esophagus, stomach, or bowel) and willingness to undergo serial tumor biopsies.
  6. Additional Inclusion Requirements for TAK-580 + nivolumab

    a) BRAF V600 mutation-positive or NRAS mutation-positive disease previously untreated with RAF, MEK, or other inhibitors of the mitogen-activated protein kinase (MAPK) pathway. Participants who have progressed on these agents can still be enrolled in TAK-202 (plozalizumab) + nivolumab or vedolizumab + nivolumab + ipilimumab.

  7. Additional Inclusion Requirements for expansion cohorts only a) per (RECIST) guidelines (Version 1.1) and at least 1 nonsignificant risk, non-target lesion accessible for biopsy per the guidelines above (for TAK-580 + nivolumab and TAK-202 (plozalizumab) + nivolumab only).

Exclusion criteria

Exclusion Criteria:

  1. Has active or . Participants with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic that could result in (greater than [>] 10 milligram per day [mg/day] prednisone equivalents) for at least 2 weeks prior to study drug administration.
  2. Completed a prior therapy less than (\<) 2 weeks prior to first dose and for whom adverse events (AEs) related to prior therapy had not returned to baseline or improved to Grade 1.
  3. Has active, known or suspected disease.
  4. Has a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
  5. Has a history of pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis (including pneumonitis), interstitial lung disease, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  6. Is previously diagnosed (HIV) infection or active or C.
  7. Additional Exclusion Requirements for arm 1 only (nivolumab Plus TAK-580)

    1. Concomitant use or administration of enzyme inducers less than or equal to (\<=) 14 days before the first dose of TAK-580.
    2. Treatment with gemfibrozil (or other strong CYP2C8 inhibitor) within 14 days before the first dose of TAK-580.
    3. (LVEF) \<50 percent (%) as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug.
    4. Known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of the TAK-580.
  8. Additional Exclusion Requirements for arm 3 only (vedolizumab Plus nivolumab Plus ipilimumab)

    1. Had prior exposure to rituximab, natalizumab, vedolizumab, or alemtuzumab.
    2. Has a history of any major neurological disorders, including stroke, multiple sclerosis, or neurodegenerative disease.
    3. Has taken any within 30 days before study drug administration except for the influenza vaccine.
Terms in these criteria, in plain language(15)

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.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

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.

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.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

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.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    TAK-580 + nivolumab

    TAK-580 orally, once weekly along with nivolumab, intravenous, every 2 weeks.

    Drug: TAK-580 · Drug: nivolumab

  • Experimental
    TAK-202 (plozalizumab) + nivolumab

    TAK-202 (plozalizumab) 2 milligram (mg), intravenous, once in Week 1, 3, 5, 9, and every 4 weeks thereafter with nivolumab infusion, intravenous, every 2 weeks.

    Drug: TAK-202 · Drug: nivolumab

  • Experimental
    vedolizumab + nivolumab + ipilimumab

    Vedolizumab intravenous, once in Week 1, 3, 5, and 13 along with nivolumab infusion, intravenous, once in Week 1, 4, 7, 10, and 13 and every 2 weeks thereafter, along with ipilimumab intravenous, once in Week 1, 4, 7, and 10.

    Drug: vedolizumab · Drug: nivolumab · Drug: ipilimumab

Interventions

  • TAK-580 tablets

    Also known as: MLN2480

  • TAK-202 infusion

    Also known as: MLN1202, plozalizumab

  • vedolizumab infusion

    Also known as: Entyvio

  • nivolumab infusion

    Also known as: Opdivo

  • ipilimumab infusion

    Also known as: Yervoy

06

What researchers measure

Primary outcomes

  1. Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase

    DLTs was evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

    Time frame: TAK-580 + Nivolumab and TAK-202 + Nivolumab: Baseline up to Week 9; Vedolizumab + Nivolumab + Ipilimumab: Baseline up to Week 7

Secondary outcomes

  1. Overall Response Rate (ORR) During the Dose-escalation Safety Lead-in Phase

    ORR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. was the percentage of participants with complete response (CR) or partial response (PR). CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD.

    Time frame: Baseline up to Week 50

  2. Duration of Response (DOR) During the Dose-escalation Safety Lead-in Phase

    DOR based on RECIST version 1.1 was the time from the date of first documented confirmed CR/PR until the first documentation of confirmed progressive disease (PD) or death, whichever occurred first. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD persistence of one or more non- target lesions and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

    Time frame: From date of first documented confirmed CR/PR until date of first documentation of PD or death (up to Week 50)

  3. Progression-free Survival (PFS) During the Dose-escalation Safety Lead-in Phase

    PFS was the time from first dose date to date of the first documentation of confirmed PD or death, whichever occurred first. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions.

    Time frame: From first dose date to the date of the first documentation of confirmed PD or death (up to Week 50)

  4. Overall Survival (OS) During the Dose-escalation Safety Lead-in Phase

    OS was the time from date of first dose of study drug until date of death from any cause.

    Time frame: From first dose of study drug until date of death from any cause (up to Week 50)

  5. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: From the first dose of study drug up to 30 days after the last dose of study drug (up to Week 50)

07

Results

Posted Apr 1, 2021

Participant flow

Participants took part in the study at 10 investigative sites in the United States from 22 June 2016 to 11 May 2018.

Participant flow — Overall Study
MilestoneArm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + Nivolumab
Started1912
Completed025
Not completed177
Withdrew: Withdrawal by subject011
Withdrew: Study terminated by sponsor166

Outcome measures

PrimaryNumber of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase

DLTs was evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Time frame:
TAK-580 + Nivolumab and TAK-202 + Nivolumab: Baseline up to Week 9; Vedolizumab + Nivolumab + Ipilimumab: Baseline up to Week 7
Reported as:
Number · DLTs
Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase
DLTsArm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + Nivolumab
Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase030
SecondaryOverall Response Rate (ORR) During the Dose-escalation Safety Lead-in Phase

ORR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. was the percentage of participants with complete response (CR) or partial response (PR). CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD.

Time frame:
Baseline up to Week 50

No measurements were reported for this outcome.

SecondaryDuration of Response (DOR) During the Dose-escalation Safety Lead-in Phase

DOR based on RECIST version 1.1 was the time from the date of first documented confirmed CR/PR until the first documentation of confirmed progressive disease (PD) or death, whichever occurred first. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD persistence of one or more non- target lesions and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Time frame:
From date of first documented confirmed CR/PR until date of first documentation of PD or death (up to Week 50)

No measurements were reported for this outcome.

SecondaryProgression-free Survival (PFS) During the Dose-escalation Safety Lead-in Phase

PFS was the time from first dose date to date of the first documentation of confirmed PD or death, whichever occurred first. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions.

Time frame:
From first dose date to the date of the first documentation of confirmed PD or death (up to Week 50)

No measurements were reported for this outcome.

SecondaryOverall Survival (OS) During the Dose-escalation Safety Lead-in Phase

OS was the time from date of first dose of study drug until date of death from any cause.

Time frame:
From first dose of study drug until date of death from any cause (up to Week 50)

No measurements were reported for this outcome.

SecondaryNumber of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame:
From the first dose of study drug up to 30 days after the last dose of study drug (up to Week 50)
Reported as:
Number · participants
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
participantsArm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + Nivolumab
TEAEs1912
SAEs127

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (up to Week 50) after the last dose of study drug. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: TAK-580 + Nivolumab0/1 (0%)1/1 (100%)1/1 (100%)
Arm 2: TAK-202 + Nivolumab0/9 (0%)2/9 (22.2%)9/9 (100%)
Arm 3: Vedolizumab + Ipilimumab + Nivolumab2/12 (16.7%)7/12 (58.3%)12/12 (100%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventArm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + Nivolumab
NauseaGastrointestinal disorders1/11/90/12
Adrenal insufficiencyEndocrine disorders1/10/90/12
Rectal haemorrhageGastrointestinal disorders0/11/90/12
Autoimmune colitisGastrointestinal disorders0/10/91/12
ColitisGastrointestinal disorders0/10/91/12
DiarrhoeaGastrointestinal disorders0/10/91/12
HypophysitisEndocrine disorders0/10/91/12
EosinophiliaBlood and lymphatic system disorders0/10/91/12
LeukocytosisBlood and lymphatic system disorders0/10/91/12
Acute coronary syndromeCardiac disorders0/10/91/12
Most frequent other events
Showing 10 of 131
Most frequent other events
EventArm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + Nivolumab
NauseaGastrointestinal disorders1/16/98/12
FatigueGeneral disorders1/14/99/12
HeadacheNervous system disorders1/13/95/12
PyrexiaGeneral disorders1/13/95/12
ArthralgiaMusculoskeletal and connective tissue disorders1/12/92/12
DehydrationMetabolism and nutrition disorders1/10/93/12
Dry mouthGastrointestinal disorders1/11/92/12
VomitingGastrointestinal disorders1/12/91/12
Acute kidney injuryRenal and urinary disorders1/10/91/12
Amylase increasedInvestigations1/10/91/12

Baseline characteristics

The safety analysis set included all participants who received at least 1 dose, even if incomplete, of study treatment (TAK-580, TAK-202, or vedolizumab).

Age, Continuous
Age, Continuous(years)Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
Mean4163.9 ± 11.5455.8 ± 16.3658.5 ± 14.90
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
Female13711
Male06511
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
Hispanic or Latino0000
Not Hispanic or Latino19919
Unknown or Not Reported0033
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0101
White181120
More than one race0000
Unknown or Not Reported0011
Region of Enrollment
Region of Enrollment(Participants)Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
United States191222
Height
Height(centimeter (cm))Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
Mean171.00168.49 ± 10.479170.00 ± 10.846169.40 ± 10.170
Weight
Weight(kilogram (kg))Arm 1: TAK-580 + NivolumabArm 2: TAK-202 + NivolumabArm 3: Vedolizumab + Ipilimumab + NivolumabTotal
Mean77.8077.42 ± 9.24888.20 ± 26.78683.32 ± 20.937
08

Study locations

14 sites
  • University of Arizona Cancer Center
    Tucson, Arizona, United States
  • University of California Los Angeles - Jonsson Comprehensive Cancer Center
    Los Angeles, California, United States
  • University of California San Francisco Medical Center
    San Francisco, California, United States
  • University of Colorado Cancer Center
    Aurora, Colorado, United States
  • Emory University Hospital
    Atlanta, Georgia, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts, United States
  • Virginia Piper Cancer Institute
    Minneapolis, Minnesota, United States
  • Washington University School of Medicine
    Saint Louis, Missouri, United States
  • New York University Langone Medical Center
    New York, New York, United States
  • Saint Luke's Cancer Center - Bethlehem
    Easton, Pennsylvania, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania, United States
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    Dallas, Texas, United States
  • Inova Fairfax Hospital
    Fairfax, Virginia, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2016 to primary completion in May 2018, 22 months.

Results were first posted in Apr 2021, 2 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2016
First posted
Mar 30, 2016
StartActual
Jun 22, 2016
Primary completionActual
May 11, 2018
CompletionActual
May 11, 2018
Results first posted
Apr 1, 2021
Last update
Mar 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02723006
Responsible party
Sponsor
First posted
Mar 30, 2016
Start date
Jun 22, 2016
Primary completion
May 11, 2018
Completion
May 11, 2018
Results posted
Apr 1, 2021
Last update
Mar 5, 2024

Study contacts

Medical Monitor
study director · Millennium Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Tovorafenib · Plozalizumab · Vedolizumab

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