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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00234 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9717 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| RG9217009 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to PI leaving institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| EMD Serono | INDUSTRY |
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This phase I/II studies the side effects of avelumab and trabectedin and how well they work in treating patients with leiomyosarcoma or liposarcoma that has spread to other places in the body (metastatic) or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab and trabectedin may work better in treating patients with liposarcoma or leiomyosarcoma.
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of the combination of trabectedin and avelumab in subjects with advanced leiomyosarcoma and liposarcoma.
II. To assess the objective response rate of advanced L-type sarcoma patients receiving the combination regimen of avelumab and trabectedin.
SECONDARY OBJECTIVE:
I. To further explore the clinical activity and safety profile of avelumab and trabectedin as a combination therapy.
OUTLINE:
Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.
After completion of study treatment, patients are followed up at 30 and 90 days, then every 12 weeks for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (1.5 mg/m^2 trabectedin + avelumab) | Experimental | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. |
|
| Phase 1 (1.0 mg/m^2 trabectedin + avelumab) | Experimental | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. |
|
| Phase 1 (1.2 mg/m^2 trabectedin + avelumab) | Experimental | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. | up to 2 years 7 months total |
| Overall Response Rate (ORR) | Rate of Partial Response (PR) + Complete Response (CR), which is the best response for each subject determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target lesions and assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Partial response is defined as a decrease in 30% or more in the sum of the longest diameter of target lesions, and complete response is defined as disappearance of all evaluable disease. No subjects had a complete response on this study so the ORR represents subjects who had a partial response only. | Up to 2 years 7 months total |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Response | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Time to response is defined as the amount of time from when the subject first received study treatment (Cycle 1, Day 1) to when they achieved a partial response on trial. With such small numbers, this data is not necessarily representative of what a larger study would report. | Up to 2 years 7 months total |
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Inclusion Criteria:
Must have a histologically confirmed diagnosis of advanced (metastatic or unresectable) soft tissue sarcoma with one of the following subtypes:
Subject must be clinically indicated to receive trabectedin therapy as part of routine care. Subjects may be first line, or have received any number of prior systemic therapies
Total bilirubin level =< 1.5 x the upper limit of normal (ULN) mg/dL
Aspartate aminotransferase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) =< 2.5 x ULN
Alkaline phosphatase < 2.5 x ULN
Serum creatinine =< 1.5 x ULN
Calculated creatinine clearance >= 30 mL/min using the Cockcroft-Gault formula may be included
Creatinine phosphokinase (CPK) =< 2.5 x ULN
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Platelet count >= 100,000/mm^3 (100 x 10^9/L)
Hemoglobin >= 9 g/dL
Subject must demonstrate a left ventricular ejection fraction (LVEF) > 45% by echocardiography (ECHO) or multigated acquisition scan (MUGA)
Male or non-pregnant and non-breast feeding female:
All ongoing toxicities related to prior therapies must be resolved to grade 1 or better (except alopecia)
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky performance scale >= 70
Subjects must have one or more measurable lesions, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
Subjects must have a life expectancy of >= 6 months, as determined by the treating physician
Ability to understand and sign informed consent document
Willingness and ability to comply with the scheduled visits, laboratory tests, and other study procedures
Exclusion Criteria:
Known active, uncontrolled, or symptomatic central nervous system (CNS) metastases; a subject with controlled and asymptomatic CNS metastases may participate in this study; as such, the subject must have completed any prior treatment for CNS metastases >= 28 days (including radiotherapy and/or surgery) prior to the start of treatment in this study and should not be receiving chronic corticosteroid therapy in excess of 10 mg daily prednisone (or equivalent) for CNS metastases; subjects with known CNS metastases must be confirmed radiographically stable by at least one imaging study, at least 28 days from last treatment
Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 2 weeks of enrollment
Prior organ transplantation, including allogeneic stem cell transplantation
Prior treatment with trabectedin
Significant acute or chronic infections including, among others:
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
Known severe hypersensitivity reactions to monoclonal antibodies (grade >= 3 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
Pregnant or lactating females
Known, active alcohol or drug abuse
All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment
Any vaccination within 4 weeks of the first dose of avelumab, with the following exceptions:
* Administration of inactivated vaccines, including inactivated flu vaccines, are allowable; however, they should not be given within 2 weeks prior to starting study treatment
Clinically significant cardiovascular disease including cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), congestive heart failure with New York Heart Association (NYHA) class II or greater or serious cardiac arrhythmia requiring medication
Severe (requiring active treatment) acute or chronic medical conditions including: colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis
Recent (within the past year) or active suicidal ideation or behavior
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| Name | Affiliation | Role |
|---|---|---|
| Seth Pollack | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Dose Level 1 | Subjects received 1.5 mg/m^2 of trabectedin plus avelumab. |
| FG001 | Phase 1 Dose Level 2 | Subjects received 1.0 mg/m^2 of trabectedin plus avelumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2020 |
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Subjects were enrolled into Phase 1, first into 1.5 mg/m^2 trabectedin dose, then 1.0 mg/m^2 trabectedin, then 1.2 mg/m^2 trabectedin. Once the recommended Phase 2 dose was selected at 1.0 mg/m^2 trabectedin, all subsequent subjects were enrolled into Phase 2.
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| Phase 2 (1.0 mg/m^2 trabectedin + avelumab) | Experimental | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. |
|
|
| Trabectedin | Drug | Given IV |
|
|
| Duration of Response | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Duration of response is defined as the amount of time a subject responded to study treatment with either a partial response or complete response until the date of last follow-up (if response ongoing at data cutoff) or the date until they progressed on study. | Up to 2 years 7 months total |
| Progression-free Survival (PFS) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, appearance of new lesions while on study, or clear growth of a non-target lesion. | At 12 weeks |
| Complete Response Rate (CR) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response is defined as disappearance of all evaluable disease. | At 12 weeks |
| Partial Response Rate (PR) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Partial response is defined as a decrease in 30% or more in the sum of the longest diameter of target lesions. | At 12 weeks |
| Stable Disease (SD) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Stable Disease is defined as neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD). | At 12 weeks |
| Clinical Benefit Rate | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Clinical Benefit Rate is defined as the percentage of subjects who achieved a Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). | At 12 weeks |
| Median Overall Survival (OS) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Up to 2 years post End of Treatment, for a total of 3 years |
| Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events | Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 2 years 7 months total |
| FG002 | Phase 1 Dose Level 3 | Subjects received 1.2 mg/m^2 of trabectedin plus avelumab. |
| FG003 | Phase 2 | Subjects received 1.0 mg/m^2 trabectedin plus avelumab. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 (1.5 mg/m^2 Trabectedin) | Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| BG001 | Phase 1 (1.0 mg/m^2 Trabectedin) | Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| BG002 | Phase 1 (1.2 mg/m^2 Trabectedin) | Phase 1: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| BG003 | Phase 2 (Avelumab, Trabectedin) | Phase 2: Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| BG004 | 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, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type of Sarcoma | Count of Participants | Participants |
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| Lines of Prior Therapy | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. | Cumulative number of adverse events experienced on trial by all patients, reported per grade. | Posted | Number | number of adverse events | up to 2 years 7 months total |
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| Primary | Overall Response Rate (ORR) | Rate of Partial Response (PR) + Complete Response (CR), which is the best response for each subject determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target lesions and assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan. Partial response is defined as a decrease in 30% or more in the sum of the longest diameter of target lesions, and complete response is defined as disappearance of all evaluable disease. No subjects had a complete response on this study so the ORR represents subjects who had a partial response only. | Subjects enrolled in Phase 2 plus subjects treated at the Recommended Phase 2 Dose (RP2D). | Posted | Number | percentage of participants | Up to 2 years 7 months total |
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| Secondary | Time to Response | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Time to response is defined as the amount of time from when the subject first received study treatment (Cycle 1, Day 1) to when they achieved a partial response on trial. With such small numbers, this data is not necessarily representative of what a larger study would report. | Average time to response for the 4 subjects who responded in both Phase 1 and Phase 2. Only subjects who had a response to treatment are included in this analysis. | Posted | Mean | Full Range | days | Up to 2 years 7 months total |
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| Secondary | Duration of Response | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Duration of response is defined as the amount of time a subject responded to study treatment with either a partial response or complete response until the date of last follow-up (if response ongoing at data cutoff) or the date until they progressed on study. | Average duration of response for the 4 subjects who responded to treatment in both Phase 1 and Phase 2. Only subjects who had a response to treatment are included in this analysis. | Posted | Mean | Full Range | days | Up to 2 years 7 months total |
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| Secondary | Progression-free Survival (PFS) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, appearance of new lesions while on study, or clear growth of a non-target lesion. | All subjects treated in Phase 1 and Phase 2 evaluated at 3 months. NOTE: one subject was not evaluable for response and was replaced after withdrawing from study before response evaluation. | Posted | Number | percentage of participants | At 12 weeks |
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| Secondary | Complete Response Rate (CR) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response is defined as disappearance of all evaluable disease. | NOTE: one subject was not evaluable for response and was replaced after withdrawing from study before response evaluation. | Posted | Count of Participants | Participants | At 12 weeks |
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| Secondary | Partial Response Rate (PR) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Partial response is defined as a decrease in 30% or more in the sum of the longest diameter of target lesions. | NOTE: One subject was not evaluable for response and was replaced after withdrawing from the study before response evaluation. | Posted | Count of Participants | Participants | At 12 weeks |
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| Secondary | Stable Disease (SD) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Stable Disease is defined as neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD). | NOTE: one subject was not evaluable for response and was replaced after withdrawing from the study before response evaluation. | Posted | Count of Participants | Participants | At 12 weeks |
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| Secondary | Clinical Benefit Rate | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Clinical Benefit Rate is defined as the percentage of subjects who achieved a Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). | Subjects with a Partial Response (PR) or Stable Disease (SD) treated at the RP2D. No subjects achieved a Complete Response (CR) while on study. | Posted | Number | percentage of participants | At 12 weeks |
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| Secondary | Median Overall Survival (OS) | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | Posted | Number | 95% Confidence Interval | days | Up to 2 years post End of Treatment, for a total of 3 years |
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| Secondary | Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events | Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Posted | Number | Events | Up to 2 years 7 months total |
|
Adverse events (AE) will be monitored from the time of first exposure to study drug (Cycle 1 Day 1) through 90 days following the last dose of a study drug, up to 2 years 7 months total. All-cause mortality was assessed from enrollment to end of study or subject death, up to 3 years total.
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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 | Phase 1 - 1.5 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV | 4 | 6 | 2 | 6 | 6 | 6 |
| EG001 | Phase 1 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. | 5 | 7 | 2 | 7 | 7 | 7 |
| EG002 | Phase 1 - 1.2mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. | 2 | 6 | 1 | 6 | 6 | 6 |
| EG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV | 1 | 16 | 7 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Tricuspid valve disease | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - other | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Small intestinal obstruction |
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| Gastrointestinal disorders - other | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Acute Diverticulitis |
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| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Biliary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
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| Tricuspid valve mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
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| Tumor Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
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| LFT Elevation | Hepatobiliary disorders | CTCAE (5.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
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| Gastrointestinal disorders - other | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Hematemesis |
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| Gastrointestinal disorders - other | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Melena |
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| Syncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Alanine aminotransferase increase | Investigations | CTCAE (5.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine Increaed | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Dry Skin | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blurred Vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline Phosphatase Increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nervous System Disorders - Other | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE (5.0) | Systematic Assessment | Port complications |
|
| Hypothyroidism | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tumor Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stomach Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle Cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Skin Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chest Pain - Cardiac | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tricuspid Valve Disease | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Watering Eyes | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| CPK increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| INR Increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Active Diverticulitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Radiculitis | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Left Total Hip Dislocation | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hallucinations | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lip Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Eye Disorders - Other | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| GGT increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Soreness | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pyrosis | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - other | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment | Heartburn |
|
| Ascites | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Body Aches | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders - other | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Psychiatric disorders - Other | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vascular disorders - other | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Infective myositis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Hypophosphatemia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoglycemia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Sebaceous Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Endocrine Disorders - Other | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Surgical and Medical Procedures - Other | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Burn | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Scalp Pain | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cardiac Disorders - Other | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seth Pollack, MD, Director of Sarcoma Program | Northwestern University | 312-503-5320 | seth.pollack@northwestern.edu |
| Mar 17, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2020 | Mar 17, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D018205 | Neoplasms, Adipose Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| D000077606 | Trabectedin |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Non-Uterine Leiomyosarcoma |
|
| Dedifferentiated Liposarcoma |
|
| Myxoid/Round Cell Liposarcoma |
|
| Pleomorphic Liposarcoma |
|
| 1 Line of Prior Therapy |
|
| 2 Lines of Prior Therapy |
|
| 3 Lines of Prior Therapy |
|
| 4 Lines of Prior Therapy |
|
| 5 Lines of Prior Therapy |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
| OG002 | Phase 1, 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2, 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|
| OG002 | Phase 1 - 1.2 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
| OG003 | Phase 2 - 1.0 mg/m^2 Trabectedin | Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression. Avelumab: Given IV Trabectedin: Given IV |
|
|