Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000906-22 | EudraCT Number |
Not provided
Not provided
Not provided
More than 2 of 6 patients treated experienced dose limiting toxicities.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche-Genentech | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Treatment of subjects who have metastatic melanoma that expresses an activated mutant form of the BRAF oncogene (V600E) with a combination of the specific BRAF inhibitor, Vemurafenib, and the Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) inhibitor mAb Ipilimumab will be safe and feasible and will show preliminary evidence of anti-tumor efficacy and survival in comparison to historical results following treatment with either agent alone.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab + Vemurafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab (BMS-734016) | Drug | Injection, intravenous (i.v.), cohort 1: 3 mg/kg, Escalate to cohort 2: 10 mg/kg, Escalate to cohort 3: at Recommended Phase 2 Dose (RP2D), De-escalate cohort 1A: 3 mg/kg, De-escalate cohort -1B: 10 mg/kg, (every three week) Q3wk, upto 2 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| During the Lead In Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Vemurafenib Alone | AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Lead In Period: between the first vemurafenib dose and the day prior to the first ipilimumab dose. | From first vemurafenib dose to day prior to first ipilimumab dose (28 days); Patients who never progressed from Lead-in to combination treatment (720 mg Alone): first dose to last dose + 90 days (approximately 2 years) |
| During the Combination Treatment Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Concurrent Ipilimumab and Vemurafenib | AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. AEs: onset on or after ipilimumab start and within 90 days of last dose. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Day 1=first dose of ipilimumab. |
Not provided
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24577748 | Derived | Ackerman A, Klein O, McDermott DF, Wang W, Ibrahim N, Lawrence DP, Gunturi A, Flaherty KT, Hodi FS, Kefford R, Menzies AM, Atkins MB, Long GV, Sullivan RJ. Outcomes of patients with metastatic melanoma treated with immunotherapy prior to or after BRAF inhibitors. Cancer. 2014 Jun 1;120(11):1695-701. doi: 10.1002/cncr.28620. Epub 2014 Feb 27. | |
| 24025700 |
Not provided
Not provided
18 participants enrolled; 12 treated with study drug and 6 participants were not treated because they no longer met study criteria. Two of the 12 only received vemurafenib while the other 10 received the combination of vemurafenib and ipilimumab.
Study started Nov 2011; Primary Endpoint April 2013; Completed safety follow-up December 2013. Dose-limiting toxicities observed early in dose escalation (Phase I) part of the study. The combination of drugs was not well tolerated, and a maximum tolerable dose was not attained so the study was closed to enrollment and Phase II part was not started.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 3 mg/kg Ipilimumab + 960 mg Vemurafenib | Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13). Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily throughout combination treatment. |
| FG001 | 3 mg/kg Ipilimumab + 720 mg Vemurafenib | Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13). Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment. |
| FG002 | 720 mg Vemurafenib | These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. Note: the dose of vemurafenib could be escalated from 720 mg to 960 mg, at the investigator's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 28 Day Lead In With Vemurafenib Alone |
| |||||||||||||
| Combination Treatment (or Intended) |
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg/kg Ipilimumab + 960 mg Vemurafenib | Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13). Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1, plus 960 mg vemurafenib orally twice daily throughout combination treatment. |
| 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 |
| 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 | During the Lead In Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Vemurafenib Alone | AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Lead In Period: between the first vemurafenib dose and the day prior to the first ipilimumab dose. | All participants who received at least one dose of study drug. | Posted | Number | participants | From first vemurafenib dose to day prior to first ipilimumab dose (28 days); Patients who never progressed from Lead-in to combination treatment (720 mg Alone): first dose to last dose + 90 days (approximately 2 years) |
From the first vemurafenib dose in the Lead In Period to the last dose of combination drugs in the Treatment Period + 90 days, up to last patient, last visit, approximately 2 years.
Final safety follow-up was 23 December 2013.
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 | Lead-In Period 960 mg Vemurafenib | Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13). Events between the first vemurafenib dose and the day prior to the first ipilimumab dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytomegalovirus enteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
In Phase 1 of the study, MTD was not reached because more than 2 of 6 treated participants experienced DLTs with the combination therapy. Enrollments in Phase 1 were terminated and Phase 2 was not started so only overall safety was summarized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D000077484 | Vemurafenib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vemurafenib | Drug | tablets, oral, cohort 1: 960 mg Twice daily (BID) x 28 days after date, cohort 2: 960 mg BID x 28 days after date, cohort 3: at Recommended Phase 2 Dose (RP2D) x 14 days after date, De-escalate cohort 1A: 720 mg BID x 28 days after date, De-escalate cohort -1B: 720 mg BID x 28 days after date , Up to 2 yrs |
|
| Combination drugs: Day 1 to last dose of drug + 90 days (approximately 2 years) |
| Number of Participants With Hepatic Dose Limiting Toxicities (DLT) in Participants Treated With Concurrent Ipilimumab and Vemurafenib | DLT defined as a >= Grade 3 drug-related AE during induction with ipilimumab in combination with vemurafenib excluding: Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor); Grade 3 cutaneous squamous cell carcinoma; Grade 3 photosensitivity that resolved to a Grade 1 or baseline within 15 days; Grade 3 immune-mediated events of the skin (rash, pruritis) or endocrine systems (hypothyroidism, hyperthyroidism, hypopituitarism, adrenal insufficiency, hypogonadism and cushingoid) that resolved to a Grade 1 or baseline within 28 days; a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Hepatic=elevated aspartate aminotransferase and alanine aminotransferase. Maximum tolerable dose (MTD) was defined as the maximum dose of combination treatment that could be given to 6 subjects such that no more than 2 subjects experience DLT. Day 1=first day of concurrent therapy with ipilimumab and vemurafenib. | Day 1 to last dose of drug + 90 (approximately 2 years) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana Farber Cancer Inst | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Ludlow SP, Pasikhova Y. Cumulative dermatologic toxicity with ipilimumab and vemurafenib responsive to corticosteroids. Melanoma Res. 2013 Dec;23(6):496-7. doi: 10.1097/CMR.0000000000000018. |
| 23415641 | Derived | Mandala M, Voit C. Targeting BRAF in melanoma: biological and clinical challenges. Crit Rev Oncol Hematol. 2013 Sep;87(3):239-55. doi: 10.1016/j.critrevonc.2013.01.003. Epub 2013 Feb 15. |
| NOT COMPLETED |
|
|
| BG001 | 3 mg/kg Ipilimumab + 720 mg Vemurafenib | Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13). Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment. |
| BG002 | 720 mg Vemurafenib | These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | During the Combination Treatment Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Concurrent Ipilimumab and Vemurafenib | AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. AEs: onset on or after ipilimumab start and within 90 days of last dose. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Day 1=first dose of ipilimumab. | All participants who received at least one dose of study drug. | Posted | Number | participants | Combination drugs: Day 1 to last dose of drug + 90 days (approximately 2 years) |
|
|
|
| Primary | Number of Participants With Hepatic Dose Limiting Toxicities (DLT) in Participants Treated With Concurrent Ipilimumab and Vemurafenib | DLT defined as a >= Grade 3 drug-related AE during induction with ipilimumab in combination with vemurafenib excluding: Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor); Grade 3 cutaneous squamous cell carcinoma; Grade 3 photosensitivity that resolved to a Grade 1 or baseline within 15 days; Grade 3 immune-mediated events of the skin (rash, pruritis) or endocrine systems (hypothyroidism, hyperthyroidism, hypopituitarism, adrenal insufficiency, hypogonadism and cushingoid) that resolved to a Grade 1 or baseline within 28 days; a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Hepatic=elevated aspartate aminotransferase and alanine aminotransferase. Maximum tolerable dose (MTD) was defined as the maximum dose of combination treatment that could be given to 6 subjects such that no more than 2 subjects experience DLT. Day 1=first day of concurrent therapy with ipilimumab and vemurafenib. | All participants who received at least one dose of concurrent study drugs. | Posted | Number | participants | Day 1 to last dose of drug + 90 (approximately 2 years) |
|
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Lead-In Period 720 mg Vemurafenib | Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13). Events between the first vemurafenib dose and the day prior to the first ipilimumab dose. | 1 | 4 | 4 | 4 |
| EG002 | Lead- In Period 720 mg Vemurafenib Alone | These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. | 1 | 2 | 2 | 2 |
| EG003 | 3 mg/kg Ipilimumab + 960 mg Vemurafenib | 3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment. | 5 | 6 | 6 | 6 |
| EG004 | 3 mg/kg Ipilimumab + 720 mg Vemurafenib | 3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment. | 2 | 4 | 4 | 4 |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Secretion discharge | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Contrast media reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Palmar erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Xerosis | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Episcleritis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Coordination abnormal | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Faeces pale | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.0 | 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.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Grade 3 SAEs |
|
| Grade 4 SAEs |
|
| Grade 5 SAEs |
|
| Drug Related Grade 3 SAEs |
|
| Drug Related Grade 4 SAEs |
|
| AEs Leading to Study Drug Discontinuation |
|
| Grade 1 irAEs |
|
| Grade 2 irAEs |
|
| Grade 3 irAEs |
|
| Grade 4 irAEs |
|
| Grade 1 AEs |
|
| Grade 2 AEs |
|
| Grade 3 AEs |
|
| Grade 4 AEs |
|
| Grade 5 AEs |
|
| Drug Related Grade 1 AEs |
|
| Drug Related Grade 2 AEs |
|
| Drug Related Grade 3 AEs |
|
| Drug Related Grade 4 AEs |
|