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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1248-8352 | Other Identifier | WHO | |
| 2019-004194-95 | EudraCT Number |
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This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.
The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts:
In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility.
In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: SCLC in ICI naïve subjects | Experimental | CC-90011 will be given orally (PO) at a dose of 40 mg on a once weekly basis in a continuous 28-day cycle. Nivolumab will be administered intravenously at a dose of 480 mg every 4 weeks per local practice as a 30 minute or a 60-minute infusion as per local practice. |
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| Cohort B: SCLC in ICI progressor subjects | Experimental | CC-90011 will be given orally (PO) at a dose of 40 mg on a once weekly basis in a continuous 28-day cycle. Nivolumab will be administered intravenously at a dose of 480 mg every 4 weeks per local practice as a 30 minute or a 60-minute infusion as per local practice. |
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| Cohort C: sqNSCLC in ICI progressor subjects | Experimental | CC-90011 will be given orally (PO) at a dose of 40 mg on a once weekly basis in a continuous 28-day cycle. Nivolumab will be administered intravenously at a dose of 480 mg every 4 weeks per local practice as a 30 minute or a 60-minute infusion as per local practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-90011 | Drug | CC-90011 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall response rate was defined as the percentage of participants in the treated population who had confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Every 6 weeks post Cycle 1 (each cycle is of 28 days) Day 1 for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participants (up to approximately 33 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 1=mild, Grade 2=Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). |
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Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Subject with histological or cytological confirmation of extensive stage Small Cell Lung Cancer (ES SCLC) or Stage IIIb or IV squamous Non-Small Cell Lung Cancer (sqNSCLC)
Subject has received 1 or 2 prior lines of therapies, defined as:
Cohort A (SCLC, Immune Checkpoint Inhibitor naïve):
Cohort B (SCLC, ICI progressors):
Cohort C (sqNSCLC, ICI progressors):
Subject has progressed at the last line of therapy.
Subject has a measurable disease defined by RECIST v1.1.
Subject agrees to provide a tumor biopsy from primary or metastatic site prior to first dose and at a pre-specified timepoint during treatment. Core biopsy is required however, in the event a core biopsy may not otherwise be feasible in the opinion of the treating physician, an endobronchial ultrasound-guided fine needle aspirate [EBUS-FNA]) biopsy, using the largest gauge needle, may be performed instead.
Subject has ECOG Performance Status of 0 to 1.
Subject must have the following laboratory values:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Subject has not recovered to Grade 2 or lower clinically significant toxicities related to the prior therapy (alopecia excluded).
Subject has received prior LSD1 therapies.
Subject has a history of severe hypersensitivity reactions to other monoclonal antibodies
Subject with symptomatic and untreated or unstable central nervous system (CNS) metastases.
Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management), or any other significant gastrointestinal (GI) disorder that could affect the absorption of the study treatments.
Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
Subject with any hemorrhage/bleeding event > NCI CTCAE Grade 2 or haemoptysis > 1 teaspoon within 4 weeks prior to the first dose.
Subject has any of the following cardiovascular criteria:
Subject has known human immunodeficiency virus (HIV) infection.
Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection.
Subject has any other malignancy within 2 years prior to enrollment, with the exception of adequately treated in-situ bladder cancer, in-situ carcinoma of the cervix, uteri, nonmelanomatous skin cancer, ductal in situ breast carcinoma, thyroid cancer, or early stage prostate cancer (all treatment of which should have been completed 6 months prior to enrollment).
Subject has medical conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of enrollment.
Subject has active autoimmune diseases or history of autoimmune diseases that may relapse. Subjects with the following diseases are allowed to be enrolled after further screening: type I diabetes, hypothyroidism managed with hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia), or diseases not expected to recur in the absence of external triggering factors.
Subject is pregnant or nursing.
Subject has a history of persistent skin rash ≥ NCI CTCAE Grade 2 related to prior ICI therapy.
Subject has organ transplant history, including allogeneic stem cell transplant.
Subject has interstitial lung disease history.
Subject has received a live/attenuated vaccine within 30 days of first dose.
Subject has previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 102 | Indianapolis | Indiana | 46260 | United States | ||
| Local Institution - 106 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A 40 mg | Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2022 |
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| Nivolumab | Drug | Nivolumab |
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| From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days) |
| Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters | Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). | Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (each cycle is of 28 days) |
| Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters | Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). | Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (Each cycle is of 28 days) |
| Number of Participants Receiving Concomitant Medication | Concomitant medication is defined as medications that were either initiated before the first dose of study drug and continued during the study treatment, or initiated on/after the date of the first dose of study drug and on/before the date of treatment discontinuation. | From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks) |
| Change From Baseline at End of Treatment in Vital Sign - Weight | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Baseline and End of Treatment (Up to 107 weeks) |
| Change From Baseline at End of Treatment in Vital Sign - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Baseline and End of Treatment (Up to 107 weeks) |
| Change From Baseline at End of Treatment in Vital Sign - Temperature | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Baseline and End of Treatment (Up to 107 weeks) |
| Change From Baseline at End of Treatment in Vital Sign - Pulse Rate | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Baseline and End of Treatment (Up to 107 weeks) |
| Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status | ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Baseline and up to End of Treatment (107 weeks) |
| Number of Participants With Treatment-emergent Adverse Events Leading to Dose Reduction of CC-90011 | Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. | From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days) |
| Number of Participants With Treatment-emergent Adverse Events Leading to Dose Interruption of CC-90011 | Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. | From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days) |
| Number of Participants With Treatment-emergent Adverse Events Leading to Dose Interruption of Nivolumab | Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. | From the start of study drug until 100 days after last dose of Nivolumab (up to 849 days) |
| Duration of Response | Duration of Response was defined as the time from the first occurrence of a confirmed documented response to the time of the first documented tumor progression, as determined by Investigator review per RECIST v1.1, or death from any cause, whichever comes first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months)) |
| Time to Response | Time to response was defined as the time from the first dose of the study drug to the date of the first confirmed documented response (CR or PR), as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months)) |
| Progression-Free Survival | Progression-Free Survival is the time from first dose of study treatment to the date of the first objectively documented tumor progression as assessed by Investigator review per RECIST v1.1 or death from any cause, whichever occurs first. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months)) |
| Time to First Subsequent Therapy | Time to First Subsequent Therapy was defined as the time from the first dose of the study drug to the date of the next cancer therapy or death. | From the first dose of study drug to the date of next cancer therapy or death due to any cause (up to approximately 33 months) |
| New York |
| New York |
| 10021 |
| United States |
| Local Institution - 105 | Canton | Ohio | 44718 | United States |
| Local Institution - 104 | Cleveland | Ohio | 44106 | United States |
| Local Institution - 109 | Pittsburgh | Pennsylvania | 15232 | United States |
| Local Institution - 107 | Fort Sam Houston | Texas | 78235-8200 | United States |
| Local Institution - 110 | Houston | Texas | 77090 | United States |
| Local Institution - 111 | Fairfax | Virginia | 22031 | United States |
| Local Institution - 156 | Lyon | 69500 | France |
| Local Institution - 153 | Marseille | 13385 | France |
| Local Institution - 154 | Rennes | 35033 | France |
| Local Institution - 151 | Saint-Herblain | 44800 | France |
| Local Institution - 152 | Villejuif | 94805 | France |
| Local Institution - 301 | Aviano | 33081 | Italy |
| Local Institution - 306 | Meldola | 47014 | Italy |
| Local Institution - 303 | Milan | 20133 | Italy |
| Local Institution - 305 | Roma | 00128 | Italy |
| Local Institution - 304 | Verona | 37134 | Italy |
| Local Institution - 451 | Lodz | 90-242 | Poland |
| Local Institution - 452 | Lodz | 93-338 | Poland |
| Local Institution - 454 | Poznan | 60-693 | Poland |
| Local Institution - 453 | Warsaw | 02-781 | Poland |
| Local Institution - 361 | A Coruña | 15006 | Spain |
| Local Institution - 351 | Badalona (Barcelona) | 08916 | Spain |
| Local Institution - 355 | Barcelona | 08023 | Spain |
| Local Institution - 356 | Barcelona | 08035 | Spain |
| Local Institution - 359 | Las Palmas de Gran Canaria | 35016 | Spain |
| Local Institution - 358 | Madrid | 28027 | Spain |
| Local Institution - 353 | Madrid | 28040 | Spain |
| Local Institution - 357 | Madrid | 28041 | Spain |
| Local Institution - 360 | Majadahonda, Madrid | 28222 | Spain |
| Local Institution - 352 | Pamplona | 31008 | Spain |
| Local Institution - 362 | Valencia | 46014 | Spain |
| Local Institution - 354 | Valencia | 46026 | Spain |
| Local Institution - 254 | London | SW3 6JJ | United Kingdom |
| Local Institution - 251 | Manchester | M20 4BX | United Kingdom |
| Local Institution - 255 | Sutton-Surrey | SM2 5PT | United Kingdom |
| FG001 |
| Cohort A 60mg |
Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| FG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| FG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A 40 mg | Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| BG001 | Cohort A 60mg | Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| BG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| BG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Overall Response Rate | Overall response rate was defined as the percentage of participants in the treated population who had confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 6 weeks post Cycle 1 (each cycle is of 28 days) Day 1 for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participants (up to approximately 33 months) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events by Maximal National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 1=mild, Grade 2=Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Count of Participants | Participants | From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days) |
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| Secondary | Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Hematology Parameters | Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab | Posted | Count of Participants | Participants | Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (each cycle is of 28 days) |
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| Secondary | Number of Participants With Laboratory Results With CTCAE Toxicity Grade >=3 for Chemistry Parameters | Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab | Posted | Count of Participants | Participants | Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 18 (Each cycle is of 28 days) |
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| Secondary | Number of Participants Receiving Concomitant Medication | Concomitant medication is defined as medications that were either initiated before the first dose of study drug and continued during the study treatment, or initiated on/after the date of the first dose of study drug and on/before the date of treatment discontinuation. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab | Posted | Count of Participants | Participants | From first dose till treatment discontinuation due to any reason (Up to approximately 107 weeks) |
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| Secondary | Change From Baseline at End of Treatment in Vital Sign - Weight | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Treated population consist of all participants who enroll and take at least one dose of either CC-90011 or nivolumab. Participants with weight measurements available at the specific timepoint were analyzed. | Posted | Mean | Standard Deviation | kilogram | Baseline and End of Treatment (Up to 107 weeks) |
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| Secondary | Change From Baseline at End of Treatment in Vital Sign - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with DBP and SBP measurements available at the specific timepoint were analyzed. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline and End of Treatment (Up to 107 weeks) |
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| Secondary | Change From Baseline at End of Treatment in Vital Sign - Temperature | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with temperature measurements available at the specific timepoint were analyzed. | Posted | Mean | Standard Deviation | degree Celsius | Baseline and End of Treatment (Up to 107 weeks) |
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| Secondary | Change From Baseline at End of Treatment in Vital Sign - Pulse Rate | Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with pulse rate measurements available at the specific timepoint were analyzed. | Posted | Mean | Standard Deviation | beats per minute | Baseline and End of Treatment (Up to 107 weeks) |
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| Secondary | Number of Participants With Post-Baseline Grade Shift in Eastern Cooperative Oncology Group Performance (ECOG) Status | ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Participants with ECOG measurements available at the specific timepoint were analyzed. | Posted | Count of Participants | Participants | Baseline and up to End of Treatment (107 weeks) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events Leading to Dose Reduction of CC-90011 | Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Count of Participants | Participants | From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events Leading to Dose Interruption of CC-90011 | Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Count of Participants | Participants | From the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events Leading to Dose Interruption of Nivolumab | Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Treatment-emergent Adverse Events are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of nivolumab study treatment. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Count of Participants | Participants | From the start of study drug until 100 days after last dose of Nivolumab (up to 849 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response was defined as the time from the first occurrence of a confirmed documented response to the time of the first documented tumor progression, as determined by Investigator review per RECIST v1.1, or death from any cause, whichever comes first. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Treated Population with confirmed Best Response of CR or PR were included in analysis. | Posted | Mean | Standard Deviation | days | Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months)) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response was defined as the time from the first dose of the study drug to the date of the first confirmed documented response (CR or PR), as assessed by Investigator review per RECIST v1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. Treated Population with confirmed best response of CR or PR. | Posted | Median | Full Range | days | Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months)) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Progression-Free Survival is the time from first dose of study treatment to the date of the first objectively documented tumor progression as assessed by Investigator review per RECIST v1.1 or death from any cause, whichever occurs first. Disease progression (PD) is defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase from time of initial PD. This includes an increase in the sum of diameters of all target lesions and/or the diameters of new measurable lesions compared to the time of the initial PD. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Mean | Standard Deviation | days | Every 6 weeks post cycle 1 day 1 (each cycle is of 28 days) for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participant (up to approximately 33 months)) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Subsequent Therapy | Time to First Subsequent Therapy was defined as the time from the first dose of the study drug to the date of the next cancer therapy or death. | Treated population consist of all participants who enrolled and took at least one dose of either CC-90011 or nivolumab. | Posted | Mean | Standard Deviation | days | From the first dose of study drug to the date of next cancer therapy or death due to any cause (up to approximately 33 months) |
|
All cause mortality was collected from first dose till death due to any cause (Up to approximately 33 months). Serious and Non-serious adverse events were collected from from the start of study drug through 28 days after the last dose of CC-90011 or until 100 days after last dose of Nivolumab (up to 849 days).
All cause mortality was collected for all the enrolled participants. Serious and Non-Serious Adverse Events were collected for all the treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A 40 mg | Participants with small cell lung cancer (SCLC) and immune checkpoint inhibitor (ICI) naive received capsule of 40 milligram (mg) of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. | 29 | 39 | 20 | 39 | 39 | 39 |
| EG001 | Cohort A 60mg | Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. | 2 | 2 | 2 | 2 | 2 | 2 |
| EG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. | 13 | 14 | 8 | 14 | 14 | 14 |
| EG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. | 32 | 37 | 25 | 35 | 33 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Cervical cord compression | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 26.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 26.1 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | 26.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.1 | Systematic Assessment |
| |
| Swelling | General disorders | 26.1 | Systematic Assessment |
| |
| Unevaluable event | General disorders | 26.1 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | 26.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 26.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Dec 6, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713087 | pulrodemstat besilate |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >= 65 - < 75 years |
|
| >= 75 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| Cohort B 40 mg |
Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| Cohort A 60mg |
Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG001 | Cohort A 60mg | Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG001 |
| Cohort A 60mg |
Participants with SCLC and ICI naive received capsule of 60 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG002 | Cohort B 40 mg | Participants with SCLC and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
|
|
| OG003 | Cohort C | Participants with squamous non-small cell lung cancer (sqNSCLC) and ICI progressor received capsule of 40 mg of CC-90011 orally once in a week in a continuous 28-day cycle. Nivolumab were administered intravenously at a dose of 480 mg every 4 weeks as a 30 minute or a 60-minute intravenous infusion. |
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