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| ID | Type | Description | Link |
|---|---|---|---|
| 2016 001459 28 | EudraCT Number | ||
| CANC 32085 | Other Identifier | National Institute for Health Research (UK) |
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Commercial reasons
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During this open label study patients will receive IMM-101 in conjunction with a recognised standard of care for metastatic or unresectable cancer for the patient's specific tumour type.
The primary objective of the study is to provide safety data for IMM-101 in combination with a number of selected standard of care regimens.
The study will consist of three phases - Screening, Treatment and Maintenance. Patients who provide informed consent, will participate in a Screening period of up to 28 days to establish eligibility. Once eligibility is confirmed, patients will enter the Treatment Phase of the study.
In the Treatment Phase all patients will receive IMM-101 for 28 weeks.
At Week 32, if the Investigator considers it in the patients' best interest patients will progress to the Maintenance Phase of the study and will continue to be dosed every 4 weeks (or as close to this interval as permitted due to practical or logistical considerations). Patients will be followed up for assessment of safety, response to treatment, survival, and immunological markers for up to 4.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMM-101 + Gem panc ca | Experimental | IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+Gem/nab-paclitaxel panc ca | Experimental | IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+Gem+capecitabine panc ca | Experimental | IMM-101 will be given in combination with gemcitabine + capecitabine combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101 + FOLFIRINOX panc ca | Experimental | IMM-101 will be given in combination with standard FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan and OXaliplatin) treatment. The treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM-101 | Biological | A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions. | Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions. | Week 28 through study completion (maximum 4.5 years) |
| Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cunningham, MD FRCP | Royal Marsden Hospital Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard, Dpt Medecine & INSERM | Lyon | 69373 | France | |||
| Gustave Roussy Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMM-101 in Combination With Anti PDL1 in Melanoma | Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death (PD)-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2016 | Mar 31, 2023 |
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| IMM-101+FOLFOX colorectal cancer (CRC) | Experimental | IMM-101 will be given in combination with standard FOLFOX (FOLinic acid, Fluorouracil and OXaliplatin) treatment. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+FOLFIRI+CETUXIMAB colorectal cancer (CRC) | Experimental | IMM-101 will be given in combination with standard FOLFIRI (FOLinic acid, Fluorouracil and IRInotecan) + cetuximab combination treatment. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+Gem cholangio | Experimental | IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+Gem lung ca | Experimental | IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter |
|
| IMM-101+Gem + nab-paclitaxel lung ca | Experimental | IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM 101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+ anti-programmed death-1 (PD1) lung ca | Experimental | IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen. |
|
| IMM-101+Gem melanoma | Experimental | IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+ anti-programmed death-1 (PD1) melanoma | Experimental | IMM-101 will be given in combination with standard treatment with either pembrolizumab or nivolumab. The first 3 patients entering the anti-PD1 (pembrolizumab or nivolumab) cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter. |
|
| IMM-101+ anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) melanoma | Experimental | IMM-101 will be given in combination with standard treatment with ipilimumab. In order to ensure that there are no increased immune-related adverse events (AEs), the first 3 patients entering the ipilimumab cohort will receive IMM-101 at an increased dosing interval of every 4 weeks. In the absence of safety concerns for these patients after 3 doses of IMM-101, and following a robust safety review, all subsequent patients recruited to this treatment cohort will switch to the standard, more intensive (2-weekly induction dosing) IMM-101 dosing regimen thereafter. |
|
| IMM-101+Gem breast cancer | Experimental | IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+Gem/ nab-paclitaxel breast | Experimental | IMM-101 will be given in combination with standard gemcitabine + nab-paclitaxel combination therapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101 + Gem sarcoma | Experimental | IMM-101 will be given in combination with standard gemcitabine monotherapy. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
|
| IMM-101+cyclophosphamide | Experimental | IMM-101 will be given in combination with low dose cyclophosphamide (300mg/m2 in patients with solid malignancies. The treatment regimen with IMM-101 will be one dose given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter. |
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| Gemcitabine | Drug | Standard of Care chemotherapy |
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| Nab-paclitaxel | Drug | Standard of Care chemotherapy |
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| Capecitabine | Drug | Standard of Care chemotherapy |
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| Folinic Acid | Drug | Standard of Care chemotherapy |
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| Fluorouracil | Drug | Standard of Care chemotherapy |
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| Irinotecan | Drug | Standard of Care chemotherapy |
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| Oxaliplatin | Drug | Standard of Care chemotherapy |
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| cetuximab | Biological | Standard of Care immunotherapy |
|
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| Anti-PD1 | Biological | Standard of Care immunotherapy |
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| Ipilimumab | Biological | Standard of Care immunotherapy |
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| Cyclophosphamide | Drug | Standard of Care chemotherapy |
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Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents |
| From screening until study termination an average of 3 months. |
| Response to Treatment | Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator:
| Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients |
| Overall Survival (OS) | Assessment of overall survival (defined as the time from enrolment to death due to any cause). | From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
| Villejuif |
| 94805 |
| France |
| St George's University of London, Institute of Infection and Immunity | London | SW17 0RE | United Kingdom |
| Royal Marsden Hospital Foundation Trust | London | SW3 6JJ | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | IMM-101 in Combination With Anti PDL1 in Melanoma | Patients diagnosed with metastatic melanoma who were receiving an anti-programmed death-1 (PD-1) agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability will be measured by incidence and severity of adverse events (AEs), Laboratory abnormalities and local injection site reactions. | Both patients were assessed | Posted | Count of Participants | Participants | Due to the early termination of the study the outcome measure timeframe was until study termination, an average of 3 months. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions. | Study was terminated before the Week 28 timepoint was reached. | Posted | Week 28 through study completion (maximum 4.5 years) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-related Adverse Events When IMM-101 is Given in Combination With a Checkpoint Blockade Inhibitor | Safety and tolerability will be measured by AEs, Laboratory abnormalities and local injection site reactions to evaluate whether there is any exacerbation of toxicity normally observed with these agents | Both patients enrolled | Posted | Count of Participants | Participants | From screening until study termination an average of 3 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Response to Treatment | Response to treatment, (defined as immune related Stable Disease (irSD), immune related Partial Response (irPR) and immune related Complete Response (irCR) as assessed by the Investigator:
| Posted | Count of Participants | Participants | Per protocol the initial assessment was at Week 28 then through study completion (maximum 4.5 years). Due to early termination of the study, response to treatment was measured at Week 11 for both patients |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Assessment of overall survival (defined as the time from enrolment to death due to any cause). | Assessment of overall survival (defined as the time from enrolment to death due to any cause). However, whilst 2 participants were monitored and analyzed, neither patient died before the study was terminated. | Posted | Count of Participants | Participants | No | From date of randomization until date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
|
|
Adverse events were collected from the time of consent until 28(±7 days) received at week 10 date which is around 3 months after the last dose of IMM-101. Serious Adverse Events were followed to resolution irrespective of the date of the last dose
Adverse events (including those reported spontaneously by the patient or observed by the Investigator) were recorded from the time of informed consent. All adverse events were followed until resolution, death or 30 days after the End of Study/Withdrawal visit (whichever came first). Study treatment related serious adverse events (SAEs) were recorded regardless of time from last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMM-101 in Combination With Anti PDL1 in Melanoma | Patients diagnosed with metastatic melanoma who were receiving an anti-PD-1 agent (nivolumab or pembrolizumab) therapy as standard of care were treated with IMM-101 in this cohort of the study. | 0 | 2 | 0 | 2 | 1 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (20) | Systematic Assessment | Head pain (at site of biopsy) |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (20) | Systematic Assessment | Subclinical hyperthyroid |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20) | Systematic Assessment |
|
Only two patients were enrolled into the study before the study was terminated early by the Sponsor for commercial reasons. There were no specific safety concerns based on the data from the two patients treated. These limited data provide some preliminary indication regarding the safety and tolerability of IMM-101 when administered in combination with nivolumab. No meaningful assessment of efficacy could be made given that only two patients were enrolled into the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Odfficer | Immodulon Therapeutics Ltd | +44 (0)20 3137 6346 | info@immodulon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2017 | Mar 31, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008545 | Melanoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| C574749 | IMM-101 |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000069287 | Capecitabine |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| D000068818 | Cetuximab |
| C000711728 | spartalizumab |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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