Not provided
Not provided
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + Ipilimumab (combination) | Experimental | Nivolumab + Ipilimumab (combination) Q3W for 4 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specific dose on specific days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. | From first dose up to approximately 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact ("last known alive date"). OS will be censored for participants at the date of first dose if they were treated but had no follow-up. | From first dose to the date of death from any cause (up to approximately 14 months) |
Not provided
Inclusion Criteria:
-Participants and Target Disease Characteristics- -
Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.
WOCBP need to use contraception throughout the study and for 5 months post treatment.
Exclusion Criteria autoimmune disease statement
Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction
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 |
|---|---|---|---|---|---|---|
| Washington University School of Medicine in St. Louis WUSTL | St Louis | Missouri | 63108 | United States | ||
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NIVO 3 + IPI 1 | Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Mar 12, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ipilimumab | Biological | Specific dose on specific days |
|
| Overall Response Rate (ORR) | Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months) |
| Duration of Response (DOR) | Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months) |
| Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months) |
| Time to Objective Response (TTR) | Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From first dose to the first confirmed documented response (up to approximately 14 months) |
| The Number of Participants Experiencing Adverse Events (AEs) | The number of participants with any grade adverse events (AEs). An 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. | From first dose and 100 days after lost dose (up to approximately 14 months) |
| Local Institution |
| Calgary |
| Alberta |
| T3B 3L1 |
| Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| BC Cancer Agency - Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Atlantic Clinical Cancer Research Unit | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC) | Hamilton | Ontario | L8V 5C2 | Canada |
| Toronto Sunnybrook Regional Cancer Ctr | Toronto | Ontario | M4N 3M5 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Montreal | Quebec | H2X 3E4 | Canada |
| Local Institution - 0005 | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution | Québec | Quebec | G2L 2Z3 | Canada |
| Local Institution - 0006 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NIVO 3 + IPI 1 | Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W). |
| 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 |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose up to approximately 14 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact ("last known alive date"). OS will be censored for participants at the date of first dose if they were treated but had no follow-up. | All treated participants | Posted | Median | 95% Confidence Interval | Months | From first dose to the date of death from any cause (up to approximately 14 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated participants with CR or PR | Posted | From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | All treated participants | Posted | Median | 95% Confidence Interval | Months | From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Objective Response (TTR) | Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated participants with CR or PR | Posted | From first dose to the first confirmed documented response (up to approximately 14 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | The Number of Participants Experiencing Adverse Events (AEs) | The number of participants with any grade adverse events (AEs). An 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. | All treated participants | Posted | Count of Participants | Participants | From first dose and 100 days after lost dose (up to approximately 14 months) |
|
|
All-cause mortality was assessed from first dose to study completion (up to approximately 14 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 14 months).
Not provided
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 | NIVO 3 + IPI 1 | Participants receive ipilimumab 1 mg/kg Q3W combined with nivolumab 3 mg/kg for up to 4 doses followed by nivolumab 480 mg every 4 weeks (Q4W). | 1 | 5 | 2 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | 24.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | 24.1 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | 24.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | 24.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | 24.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
The study was terminated early, leading to small numbers of participants analyzed.
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 |
| Nov 15, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|