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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003291-38 | EudraCT Number |
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Discontinued early due to enrollment challenges and changes in treatment standards
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The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipilimumab, 3 mg/kg | Experimental | Participants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent |
|
| Chemotherapy | Active Comparator | Participants received the investigator's choice of chemotherapy, administered per package instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date) | From randomization to death or last known alive date, assessed up to 15.6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs) | 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. |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology & Oncology Associates Llc | Birmingham | Alabama | 35205 | United States | ||
| Rocky Mountain Cancer Centers |
A total of 31 participants were enrolled. Of the 23 who were randomized, 22 received treatment .
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipilimumab, 3 mg/kg | Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent |
| FG001 | Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Chemotherapy |
| Drug |
|
| Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease |
| Best Overall Response Rate (BORR) | BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed. | Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease |
| From Day 1 of treatment to 90 days after last dose (or to death date for death information) |
| Aurora |
| Colorado |
| 80012 |
| United States |
| Investigative Clinical Research Of Indiana, Llc | Indianapolis | Indiana | 46260 | United States |
| Cancer Center Of Kansas | Wichita | Kansas | 67214 | United States |
| Comprehensive Cancer Center Of Nevada | Las Vegas | Nevada | 89148 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Texas Oncology Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Local Institution | Vienna | A-1090 | Austria |
| Local Institution | Bordeaux | 33075 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Paris | 75010 | France |
| Local Institution | Cologne | 50937 | Germany |
| Local Institution | Erfurt | 99089 | Germany |
| Local Institution | Göttingen | 37075 | Germany |
| Local Institution | Heidelberg | 69115 | Germany |
| Local Institution | Kiel | 24105 | Germany |
| Local Institution | Siena | 53100 | Italy |
Participants received the investigator's choice of chemotherapy, dosed per package instructions.
| Received Treatment |
|
| Still Receiving Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipilimumab, 3 mg/kg | Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent |
| BG001 | Chemotherapy | Participants received the investigator's choice of chemotherapy, dosed per package instructions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG is a 6-item scale used to assess disease progression, daily functioning, appropriate treatment, and prognosis. Performance status is scored on a scale ranging from 0-5, with (best score) 0=fully active and able to carry on all predisease performance without restriction and (worst score) 5=death. | Number | Participants |
| |||||||||||||||
| Disease Stage at Study Entry | By the American Joint Committee on Cancer staging: Stage 1=no spread to lymph nodes/organs, <1 mm thick and not ulcerated (1A) or <1 mm thick and ulcerated or 1-2 mm thick and not ulcerated (1B). Stage 2=no spread to lymph nodes (LN) or other organs, 1-2 mm thick and ulcerated or 2-4 mm thick and not ulcerated (2A) or 2-4 mm thick and ulcerated or >4 mm thick and not ulcerated (2B), or >4 mm thick and ulcerated (2C). Stage 3 (A,B,C)=any thickness, ulcerated or not, and spread to nearby LN or nearby tissue but not LN. Stage 4=spread to LN, other organs, or areas far from original tumor site. | Number | Participants |
| |||||||||||||||
| Objective Response to Prior Ipilimumab Treatment | Tumors assessed per Response Evaluation Criteria In Solid Tumors Criteria for target lesions: Complete response (CR)=disappearance of all target lesions. Partial response (PR)=30% or greater decrease in sum of the longest diameter (LD) of target lesions. Progressive disease (PD)=a 20% or greater increase in sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Stable disease=neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Objective response=number of patients with best response of CR or PR. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date) | All participants who were randomized | Posted | Median | Full Range | Months | From randomization to death or last known alive date, assessed up to 15.6 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed. | All participants who were randomized | Posted | Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response Rate (BORR) | BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed. | All participants who were randomized | Posted | Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease |
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs) | 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. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | From Day 1 of treatment to 90 days after last dose (or to death date for death information) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipilimumab, 3 mg/kg | Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent | 7 | 18 | 15 | 18 | ||
| EG001 | Chemotherapy | Participants received the investigator's choice of chemotherapy, dosed per package instructions. | 0 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood corticotrophin decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
As planned, accrual of participants was to be completed within 21 months. However, current projections showed that 4 to 5 years were needed. The study was terminated early because the scientific objective could not be met in the predefined timeframe.
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 | 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D004358 | Drug Therapy |
| 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 |
| D013812 | Therapeutics |
Not provided
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| Male |
|
| 1 |
|
| Stage IV |
|
| Stable disease |
|
|
|
|