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| ID | Type | Description | Link |
|---|---|---|---|
| CA209-9JX | Other Identifier | Bristol-Myers Squibb |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This research study is studying a drug called Carboplatin with or without another study drug, Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other parts of the body.
The interventions involved in this study are:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved nivolumab for your specific disease but it has been approved for other uses. The FDA has approved carboplatin as a treatment option for your disease.
The purpose of this research study is to determine how well carboplatin, by itself, or together with nivolumab, works in treating breast cancer that has spread to other parts of the body. Nivolumab is a recently discovered human monoclonal antibody. An antibody is a type of protein that your immune system (the system that defends your body against potentially harmful particles) uses to find and destroy foreign molecules (particles not typically found in your body, such as bacteria and viruses). Scientists can now make antibodies in the laboratory and produce them for the treatment of many different diseases.
Nivolumab works by attaching to and blocking a molecule called PD-1. PD-1 is a different molecule that can turn off the immune system by interacting with PD-L1 on the cancer cell. Nivolumab has been shown in research studies to prevent PD-1 from shutting down the immune system, thus allowing it to recognize and help your body destroy the cancer cells. You are being asked to participate in this study because triple-negative breast cancer has shown elevated rates of PD-L1 expression.
Nivolumab has been used in other research studies and information from those research studies suggests that nivolumab may help shrink or stabilize your triple negative breast cancer in this study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin + Nivolumab | Experimental |
|
|
| Carboplatin | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin interferes with the development of the genetic material in a cell, which will cause the cancer cells to die. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation | Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 | Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1 |
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Inclusion Criteria:
Participants must have histologically or cytologically confirmed invasive breast cancer, with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
Estrogen-receptor and progesterone-receptor expression both ≤ 1% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines. If a patient has more than one histological result, the most recent sample will be considered for inclusion.
Participants must have PD-L1 status available at the time of registration. Standard local testing with any PD-L1 antibody that has been validated in a CLIA-certified environment will be acceptable for including patients on trial.. Primary or metastatic samples may be tested for PD-L1 status.
Participants must have measurable or evaluable disease by RECIST version 1.1.
Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline. Previously collected archival tissue will also be obtained on all participants. For participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) the archival tissue alone will be acceptable. Tissue needs to be located and availability confirmed at time of registration (See Section 9 for more details). Participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible. For patients randomized to carboplatin alone who decide to crossover to nivolumab and nab-paclitaxel at time of progression, a mandatory biopsy will be required if tumor is safely accessible prior to initiating crossover treatment; participants must also agree to undergo this biopsy, if applicable.
Prior chemotherapy: Participants must have received 0 prior chemotherapeutic regimens for metastatic breast cancer. Prior platinum in the neo/adjuvant setting is permissible, if at least 6 months elapsed since the end of adjuvant systemic therapy to the development of metastatic disease. All toxicities related to prior chemotherapy must have resolved to CTCAE v4.0 grade 1 or lower, unless otherwise specified.
Prior biologic therapy: Prior poly-ADP ribose polymerase (PARP) inhibitors are not allowed in the metastatic setting. Prior PARP inhibitors in the neo/adjuvant setting are permissible, if at least 6 months elapsed since the end of adjuvant systemic therapy to the development of metastatic disease. All toxicities related to prior biologic therapy must have resolved to CTCAE v4.0 grade 1 or lower, unless otherwise specified.
Prior radiation therapy: Patients may have received prior radiation therapy. Radiation therapy must be completed at least 14 days prior to registration, and all toxicities related to prior radiation therapy must have resolved to CTCAE v4.0 grade 1 or lower, unless otherwise specified in 3.1.10. Patients may not have had >25% of their bone marrow radiated.
The subject is ≥18 years old.
ECOG performance status ≤1 (Karnofsky >60%, see Appendix A).
Participants must have normal organ and marrow function as defined below:
Absolute neutrophil count ≥1,500/mcL
Platelets ≥100,000/mcL
Hemoglobin ≥ 9.0 g/dl
Total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)
AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or
≤5 × institutional ULN for participants with documented liver metastases
Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 45 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.
Supportive care (e.g. transfusion of red blood cells) is allowed to meet eligibility criteria.
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to registration.
Childbearing potential is defined as: participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception. Contraception is required starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment (i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five half-lives.)
Participants on bisphosphonates or RANK ligand inhibitors may continue receiving therapy during study treatment.
The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Tolaney, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Stamford Hospital | Stamford | Connecticut | 06904 | United States | ||
| Eastern Maine Medical Center |
96 patients were assessed for eligibility, and 18 were found to be ineligible. A total of 78 patients were enrolled and randomized.
The first patient was enrolled on February 12, 2018, and the last patient was enrolled on September 23, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Carboplatin + Nivolumab |
|
| FG001 | Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First-course Treatment |
|
| ||||||||||||||||||||||||
| Crossover Treatment |
|
78 patients were enrolled and randomized, but only 75 patients started protocol therapy. The primary analysis population is the treated population, thus baseline characteristics are shown for the 75 patients that started protocol therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Carboplatin + Nivolumab |
|
| BG001 | Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Progression-free Survival | Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation | The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment. | Posted | Median | 95% Confidence Interval | months | Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years |
|
Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years.
An SAE is any untoward medical occurrence that:
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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 | Arm A: Carboplatin + Nivolumab |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Tolaney, MD, MPH | Dana-Farber Cancer Institute | 617-632-5743 | Sara_Tolaney@dfci.harvard.edu |
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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 | Feb 2, 2021 | Nov 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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| Nivolumab | Drug | Nivolumab works by attaching to and blocking a molecule called PD-1. PD-1 is a different molecule that can turn off the immune system by interacting with PD-L1 on the cancer cells |
|
|
| Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Objective Response Rate by Immune-Related Response Criteria (irRC) | Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Overall Survival | Defined as the time from randomization to death due to any cause, or censored at date last known alive | Assessed from date of randomization until the date of death from any cause, up to 3.5 years |
| Clinical Benefit Rate | Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Duration of Response | Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years |
| Time to Objective Response | Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded | Assessed from randomization to the time of first response, up to 3.5 years |
| Progression-free Survival Among PD-L1-positive Patients | PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years |
| Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients | ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Objective Response Rate by irRC Among PD-L1-positive Patients | ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Overall Survival Among PD-L1-positive Patients | OS defined as the time from randomization to death due to any cause, or censored at date last known alive. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from date of randomization until the date of death from any cause, up to 3.5 years |
| Clinical Benefit Rate Among PD-L1-positive Patients | CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Duration of Response Among PD-L1-positive Patients | DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years |
| Time to Objective Response Among PD-L1-positive Patients | TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Assessed from randomization to the time of first response, up to 3.5 years |
| Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. | Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years |
| Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1., during crossover therapy | Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years |
| Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC, during second-course therapy | Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years |
| Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy | Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years |
| Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter. Patients without events reported are censored at the last disease evaluation. | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years |
| Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded | Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years |
| Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive. | Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years |
| Progression-free Survival Among BRCA-mutant Patients | PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. BRCA-mutant patients were those having BRCA1 or BRCA2 mutations. | Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years |
| Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients | ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Objective Response Rate by irRC Among BRCA-mutant Patients | ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Overall Survival Among BRCA-mutant Patients | OS defined as the time from randomization to death due to any cause, or censored at date last known alive. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | From date of randomization until the date of death from any cause, assessed up to 3.5 years |
| Clinical Benefit Rate Among BRCA-mutant Patients | CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
| Duration of Response Among BRCA-mutant Patients | DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years |
| Time to Objective Response Among BRCA-mutant Patients | TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | Assessed from randomization to the time of first response, up to 3.5 years |
| Bangor |
| Maine |
| 04401 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford | Massachusetts | 01757 | United States |
| Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital | South Weymouth | Massachusetts | 02190 | United States |
| Dana-Farber/New Hampshire Oncology-Hematology | Londonderry | New Hampshire | 03053 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Progressive Disease |
|
| Adverse Event |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| "Patient proceeded with chest wall excision" |
|
| "Participant needed palliative radiation, which is not permitted on study" |
|
| Still on treatment |
|
| Never started protocol therapy |
|
| NOT COMPLETED |
|
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Germline BRCA Status | Count of Participants | Participants |
|
| Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local | Count of Participants | Participants |
|
| Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142 | Count of Participants | Participants |
|
| Stromal tumor-infiltrating lymphocytes (sTILs) | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Count of Participants | Participants |
|
| Inflammatory breast cancer | Count of Participants | Participants |
|
| Prior anthracycline in neoadjuvant/adjuvant setting | Count of Participants | Participants |
|
| Prior taxane in neoadjuvant/adjuvant setting | Count of Participants | Participants |
|
| Prior platinum in neoadjuvant/adjuvant setting | Count of Participants | Participants |
|
| Number of lines of prior chemotherapy for advanced disease | Count of Participants | Participants |
|
| Baseline lactate dehydrogenase (LDH) | Count of Participants | Participants |
|
| OG001 | Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion |
|
|
|
|
| Secondary | Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 | Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1 | The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
|
| Secondary | Objective Response Rate by Immune-Related Response Criteria (irRC) | Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC | First-course objective response rate by irRC was only evaluated in the 32 patients that received immunotherapy (on Arm A) in the ITT population. Because of this, statistical testing by arm was not performed. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
| Secondary | Overall Survival | Defined as the time from randomization to death due to any cause, or censored at date last known alive | The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment. | Posted | Median | 95% Confidence Interval | months | Assessed from date of randomization until the date of death from any cause, up to 3.5 years |
|
|
|
|
| Secondary | Clinical Benefit Rate | Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks | The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
|
| Secondary | Duration of Response | Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. | Duration of response was analyzed among the total 15 patients who achieved objective response in the ITT population. | Posted | Median | 95% Confidence Interval | months | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years |
|
|
|
|
| Secondary | Time to Objective Response | Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded | The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment. | Posted | Median | 95% Confidence Interval | months | Assessed from randomization to the time of first response, up to 3.5 years |
|
|
|
|
| Secondary | Progression-free Survival Among PD-L1-positive Patients | PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | A total of 24 patients were PD-L1-positive in the ITT population. | Posted | Median | 95% Confidence Interval | months | Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years |
|
|
|
|
| Secondary | Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients | ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | A total of 24 patients were PD-L1-positive in the ITT population. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
|
| Secondary | Objective Response Rate by irRC Among PD-L1-positive Patients | ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | A total of 13 patients were treated with immunotherapy (on Arm A) and were PD-L1-positive in the ITT population. Because first-course irORR was only assessed for patients on Arm A, no statistical testing by arm was performed. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
| Secondary | Overall Survival Among PD-L1-positive Patients | OS defined as the time from randomization to death due to any cause, or censored at date last known alive. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | A total of 24 patients were PD-L1-positive in the ITT population. | Posted | Median | 95% Confidence Interval | months | Assessed from date of randomization until the date of death from any cause, up to 3.5 years |
|
|
|
|
| Secondary | Clinical Benefit Rate Among PD-L1-positive Patients | CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | A total of 24 patients were PD-L1-positive in the ITT population. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
|
| Secondary | Duration of Response Among PD-L1-positive Patients | DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | Duration of response was assessed only among the 6 PD-L1-positive patients in the ITT population who achieved objective response. Due to insufficient sample size, statistical testing by arm was not performed. | Posted | Median | 95% Confidence Interval | months | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years |
|
|
|
| Secondary | Time to Objective Response Among PD-L1-positive Patients | TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1. | A total of 24 patients were PD-L1-positive in the ITT population. | Posted | Median | 95% Confidence Interval | months | Assessed from randomization to the time of first response, up to 3.5 years |
|
|
|
|
| Secondary | Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. | 10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab | Posted | Median | 95% Confidence Interval | months | Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years |
|
|
|
| Secondary | Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1., during crossover therapy | 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years |
|
|
|
| Secondary | Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC, during second-course therapy | 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years |
|
|
|
| Secondary | Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy | 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years |
|
|
|
| Secondary | Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter. Patients without events reported are censored at the last disease evaluation. | 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab, and only 2 of these patients achieved objective response | Posted | Median | 95% Confidence Interval | months | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years |
|
|
|
| Secondary | Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded | 10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab | Posted | Median | 95% Confidence Interval | months | Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years |
|
|
|
| Secondary | Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab | Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive. | 10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab | Posted | Median | 95% Confidence Interval | months | Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years |
|
|
|
| Secondary | Progression-free Survival Among BRCA-mutant Patients | PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation. BRCA-mutant patients were those having BRCA1 or BRCA2 mutations. | A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations. | Posted | Median | 95% Confidence Interval | months | Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years |
|
|
|
| Secondary | Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients | ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
| Secondary | Objective Response Rate by irRC Among BRCA-mutant Patients | ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | There were 0 patients treated with immunotherapy (on Arm A) and had BRCA1 or BRCA2 mutations in the ITT population. | Posted | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
| Secondary | Overall Survival Among BRCA-mutant Patients | OS defined as the time from randomization to death due to any cause, or censored at date last known alive. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations. | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of death from any cause, assessed up to 3.5 years |
|
|
|
| Secondary | Clinical Benefit Rate Among BRCA-mutant Patients | CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations. | Posted | Number | 95% Confidence Interval | percent of patients | Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years |
|
|
|
| Secondary | Duration of Response Among BRCA-mutant Patients | DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | Only 1 patient in the ITT cohort that had a BRCA1 or BRCA2 mutation also achieved objective response. | Posted | Median | 95% Confidence Interval | months | Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years |
|
|
|
| Secondary | Time to Objective Response Among BRCA-mutant Patients | TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded. BRCA-mutant patients were those with BRCA1 or BRCA2 mutations. | A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations. | Posted | Median | 95% Confidence Interval | months | Assessed from randomization to the time of first response, up to 3.5 years |
|
|
|
| 24 |
| 37 |
| 10 |
| 37 |
| 37 |
| 37 |
| EG001 | Arm B: Carboplatin |
| 17 | 38 | 11 | 38 | 38 | 38 |
| EG002 | Arm B: Carboplatin -- Crossover |
| 10 | 18 | 6 | 18 | 18 | 18 |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Joint infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infusion related reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin/subcutaneous tissue disorders; Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphedema | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |