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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01178 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The goal of this clinical research study is to learn if the combination of durvalumab and tremelimumab can help to control sarcoma. The safety of this drug combination will also be studied.
This is an investigational study. Durvalumab and tremelimumab are not FDA approved or commercially available. They are currently being used for research purposes only. The study doctor can explain how the study drugs are designed to work.
Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive tremelimumab and durvalumab by vein, over about 1 hour each, every 4 weeks for up to 16 weeks (4 doses). After Week 16, you may continue to receive durvalumab alone by vein over about 1 hour for an additional 32 weeks (8 doses).
If you have a side effect related to the combination of durvalumab and tremelimumab during the first 16 weeks of the study, you may be able to switch over to receive durvalumab alone sooner than expected. This will be discussed with you.
Study Visits:
On Day 1 of Week 0:
On Day 1 of Weeks 2 and 6, blood (about 3½ tablespoons) will be drawn for routine, genetic, and biomarker testing.
On Day 1 of Week 4 and then every 4 weeks after that (Weeks 8, 12, 16, and so on) until Week 44:
On Day 1 of Weeks 10 and 14, blood (about 1 tablespoon) will be drawn for routine tests.
Length of Study:
You may receive up to 4 doses of durvalumab in combination with tremelimumab and up to an additional 8 doses of durvalumab alone. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
If you complete 12 months of therapy but the disease appears to get worse, you may be able to re-start treatment. The study doctor will discuss this with you.
It is expected that your participation in this study may last up to 15 months. Your participation on the study will be over after the follow-up visits.
End-of-Treatment Visit:
As soon as possible after your last dose of study drug(s):
Follow-Up Visit:
About 30 days after your last dose of study drug(s):
You will have a physical exam. Blood (about 1 tablespoon) will be drawn for routine tests.
Long-Term Follow-Up
Every 3 months:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipocytic Tumors Group | Experimental | Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. |
|
| Vascular Tumors Group | Experimental | Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. |
|
| Undifferentiated Pleomorphic Sarcoma Group | Experimental | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20%increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | 8 weeks, confirmatory scan at least 4 wks or later |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neeta Somaiah, MBBS | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35934010 | Derived | Somaiah N, Conley AP, Parra ER, Lin H, Amini B, Solis Soto L, Salazar R, Barreto C, Chen H, Gite S, Haymaker C, Nassif EF, Bernatchez C, Mitra A, Livingston JA, Ravi V, Araujo DM, Benjamin R, Patel S, Zarzour MA, Sabir S, Lazar AJ, Wang WL, Daw NC, Zhou X, Roland CL, Cooper ZA, Rodriguez-Canales J, Futreal A, Soria JC, Wistuba II, Hwu P. Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial. Lancet Oncol. 2022 Sep;23(9):1156-1166. doi: 10.1016/S1470-2045(22)00392-8. Epub 2022 Aug 4. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adipocytic Tumors Group | Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG001 | Vascular Tumors Group | Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG002 | Undifferentiated Pleomorphic Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG003 | Synovial Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG004 | Osteosarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG005 | Other Sarcomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG006 | Alveolar Soft-part Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| FG007 | Chordomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adipocytic Tumors Group | Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (PFS) | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20%increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Number | 95% Confidence Interval | proportion of participants | 12 weeks |
|
4 years
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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 | Adipocytic Tumors Group | Adipocytic Tumors Group consists of well-diff/de-differentiated, pleomorphic and myxoid LPS. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neeta Somaiah | The University of Texas MD Anderson Cancer Center | (713) 792-3626 | nsomaiah@mdanderson.org |
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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 | Sep 10, 2019 | Jan 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019043 | Vascular Neoplasms |
| D007890 | Leiomyosarcoma |
| D006394 | Hemangiosarcoma |
| D018323 | Hemangioendothelioma, Epithelioid |
| D051677 | Histiocytoma, Malignant Fibrous |
| D013584 | Sarcoma, Synovial |
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D012983 | Soft Tissue Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
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| Synovial Sarcoma Group | Experimental | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. |
|
| Osteosarcoma Group | Experimental | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. |
|
| Other Sarcomas Group | Experimental | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. |
|
| Tremelimumab | Drug | Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
|
| Overall Survival (OS) | OS defined as the time from treatment onset to death. OS estimated using the Kaplan-Meier method. | 44 months |
| Adverse Event |
|
| Pregnancy |
|
| BG001 | Vascular Tumors Group | Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG002 | Undifferentiated Pleomorphic Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG003 | Synovial Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG004 | Osteosarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG005 | Other Sarcomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG006 | Alveolar Soft-part Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG007 | Chordomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Vascular Tumors Group | Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| OG002 | Undifferentiated Pleomorphic Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| OG003 | Synovial Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| OG004 | Osteosarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| OG005 | Other Sarcomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| OG006 | Alveolar Soft-part Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
| OG007 | Chordomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. |
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| Secondary | Tumor Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR),Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR | Posted | Count of Participants | Participants | 8 weeks, confirmatory scan at least 4 wks or later |
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|
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| Secondary | Overall Survival (OS) | OS defined as the time from treatment onset to death. OS estimated using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | 44 months |
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|
|
| 4 |
| 6 |
| 5 |
| 6 |
| 2 |
| 6 |
| EG001 | Vascular Tumors Group | Vascular Tumors Group consists of leiomyosarcomas, angiosarcomas, epithelioid hemangioendotheliomas, and hemangiopericytomas. Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 8 | 10 | 7 | 10 | 3 | 10 |
| EG002 | Undifferentiated Pleomorphic Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by Durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 5 | 5 | 4 | 5 | 2 | 5 |
| EG003 | Synovial Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 4 | 5 | 0 | 5 | 1 | 5 |
| EG004 | Osteosarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 5 | 5 | 4 | 5 | 2 | 5 |
| EG005 | Other Sarcomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 10 | 11 | 8 | 11 | 5 | 11 |
| EG006 | Alveolar Soft-part Sarcoma Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 2 | 10 | 6 | 10 | 4 | 10 |
| EG007 | Chordomas Group | Age group ≥12 and <18: Dosages of study drugs to be determined (TBD). Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles. Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses. Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses). Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles. | 0 | 5 | 1 | 5 | 2 | 5 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Myocarditis | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Autoimmune disorder | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.03) | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
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| Stroke | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
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| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | CTCAE (4.03) | Systematic Assessment |
|
| Flu | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.03) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Disease Progression | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Blood bilirubin increased | Investigations | CTCAE (4.03) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.03) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | CTCAE (4.03) | Systematic Assessment |
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| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
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| Acute renal insufficiency | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
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| Remove tumor | Surgical and medical procedures | CTCAE (4.03) | Systematic Assessment |
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| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (4.03) | Systematic Assessment |
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| Gait disturbance | General disorders | CTCAE (4.03) | Systematic Assessment |
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| Enterocolitis infectious | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.03) | Systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Wound infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| chest | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | CTCAE (4.03) | Systematic Assessment |
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| Tracheal obstruction | Injury, poisoning and procedural complications | CTCAE (4.03) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.03) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.03) | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (including cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.03) | Systematic Assessment |
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| Heart failure | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.03) | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | CTCAE (4.03) | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| fracture right femur | Injury, poisoning and procedural complications | CTCAE (4.03) | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | CTCAE (4.03) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Lipase increased | Investigations | CTCAE (4.03) | Systematic Assessment |
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| Serum amylase increased | Investigations | CTCAE (4.03) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (4.03) | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE (4.03) | Systematic Assessment |
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| Autoimmune disorder | Immune system disorders | CTCAE (4.03) | Systematic Assessment |
|
| Thrush | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | CTCAE (4.03) | Systematic Assessment |
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| Endocrine disorders - Other, specify | Endocrine disorders | CTCAE (4.03) | Systematic Assessment |
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| Myocarditis | Cardiac disorders | CTCAE (4.03) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Rash (left shoulder) | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Rash (Left Leg) | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.03) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Flu like symptoms | General disorders | CTCAE (4.03) | Systematic Assessment |
|
| Rash lower back | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| Malaise | General disorders | CTCAE (4.03) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Proctitis | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.03) | Systematic Assessment |
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| General disorders and administration site conditions - Other, specify | General disorders | CTCAE (4.03) | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE (4.03) | Systematic Assessment |
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Not provided
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D012509 | Sarcoma |
| D009383 | Neoplasms, Vascular Tissue |
| D006390 | Hemangioendothelioma |
| D006391 | Hemangioma |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018213 | Neoplasms, Bone Tissue |
| Best Response irRC - PD |
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| Best Response irRC - PR |
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| Best Response irRC - SD |
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| Best Response irRC - uPD |
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| Best Response iRecist - N/A |
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| Best Response iRecist - PD |
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| Best Response iRecist - PR |
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| Best Response iRecist - SD |
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| Best Response iRecist - uPD |
|