SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy of pembrolizumab in patients with advanced sarcomas.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is a multi-institutional phase II study of pembrolizumab in patients with advanced sarcomas. This study will have two treatment groups, one group for patients with soft tissue sarcoma and one group for patients with bone sarcoma.
Initial enrollment for this study included a total of 86 patients with soft tissue sarcoma and bone sarcomas.
In the expansion portion, there will be an additional 30 patients with undifferentiated pleomorphic sarcoma (UPS) and 30 patients with dedifferentiated or other high grade liposarcoma (LPS) enrolled into the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Soft tissue sarcoma Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks |
Drug: Pembrolizumab
Other Names:
|
| Experimental: Bone sarcoma Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks |
Drug: Pembrolizumab
Other Names:
|
| Experimental: Expansion Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
Drug: Pembrolizumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate [Assessments will be conducted at 8 weeks, up to 5 years]
The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR.
Secondary Outcome Measures
- Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient [Up to 5 years]
Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product.
- The Progression-free Survival (PFS) [up to 5 yrs]
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
- Response Rate by Immune-related Response Criteria (Ir-RC) [Assessment at 8 weeks, up to 5 years]
Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions
- Overall Survival (OS) [up to 5 years]
The Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease and are still alive
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years (Age ≥ 12 years for patients with bone sarcomas).
-
Histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic high grade soft-tissue or bone sarcoma of one of the following subtypes: soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]).
-
ECOG Performance Status of 0 or 1.
-
At least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing.
-
At least one site of accessible disease for pre- and post-treatment core biopsies for at least 20 patients per arm on the expansion cohorts.
-
Patients may have received 1-3 prior systemic therapies in the metastatic setting.
-
Adequate organ function within 14 days of dosing
-
Must be willing to provide and have available archival tissue for PD-L1 testing.
-
Written, voluntary informed consent.
-
Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study.
-
Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence.
-
Life expectancy of >12 weeks.
-
Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab.
Exclusion Criteria:
-
Prior systemic therapy targeting PD-1: PD-L1 axis.
-
Patients who are curable by conventional multidisciplinary management.
-
Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
-
Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy.
-
Patients who have active infections requiring therapy.
-
Patients that are known to be positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA [qualitative] is detected); patients with negative Hepatitis C antibody testing may not need RNA testing.
-
Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
-
Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
-
Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.
-
Women who are pregnant or nursing/breastfeeding.
-
Known hypersensitivity to pembrolizumab or another mAb.
-
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
-
Patients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible.
-
Inability to comply with protocol required procedures.
-
Patients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening.
-
Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis).
-
Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90033 |
| 2 | Medstar Health Research Institute | Washington | District of Columbia | United States | 20010 |
| 3 | Mayo Clinic Florida | Jacksonville | Florida | United States | 32224 |
| 4 | H. Lee Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 5 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 6 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 7 | Washington University in St. Louis | Saint Louis | Missouri | United States | 63110 |
| 8 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 9 | Duke University | Durham | North Carolina | United States | 27705 |
| 10 | Oregon Health and Science University | Portland | Oregon | United States | 97201 |
| 11 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 12 | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
Sponsors and Collaborators
- Sarcoma Alliance for Research through Collaboration
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Hussein Tawbi, MD, PhD, The University of Texas MD Anderson Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.- SARC028
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion Cohort |
|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
| Period Title: Overall Study | |||
| STARTED | 42 | 42 | 60 |
| COMPLETED | 42 | 42 | 60 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: Liposarcoma and Pleomorphic sarcoma | Total of all reporting groups |
| Overall Participants | 42 | 42 | 60 | 144 |
| Age (Count of Participants) | ||||
| <=18 years |
1
2.4%
|
6
14.3%
|
0
0%
|
7
4.9%
|
| Between 18 and 65 years |
32
76.2%
|
34
81%
|
38
63.3%
|
104
72.2%
|
| >=65 years |
9
21.4%
|
2
4.8%
|
22
36.7%
|
33
22.9%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
35.7%
|
16
38.1%
|
17
28.3%
|
48
33.3%
|
| Male |
27
64.3%
|
26
61.9%
|
43
71.7%
|
96
66.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
2
4.8%
|
1
2.4%
|
5
8.3%
|
8
5.6%
|
| Not Hispanic or Latino |
36
85.7%
|
37
88.1%
|
53
88.3%
|
126
87.5%
|
| Unknown or Not Reported |
4
9.5%
|
4
9.5%
|
2
3.3%
|
10
6.9%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
1
2.4%
|
0
0%
|
1
0.7%
|
| Asian |
2
4.8%
|
1
2.4%
|
1
1.7%
|
4
2.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
7.1%
|
2
4.8%
|
4
6.7%
|
9
6.3%
|
| White |
36
85.7%
|
35
83.3%
|
51
85%
|
122
84.7%
|
| More than one race |
0
0%
|
1
2.4%
|
0
0%
|
1
0.7%
|
| Unknown or Not Reported |
1
2.4%
|
2
4.8%
|
4
6.7%
|
7
4.9%
|
Outcome Measures
| Title | Objective Response Rate |
|---|---|
| Description | The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR. |
| Time Frame | Assessments will be conducted at 8 weeks, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response. |
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion Cohort |
|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
| Measure Participants | 40 | 40 | 53 |
| Count of Participants [Participants] |
7
16.7%
|
2
4.8%
|
7
11.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Soft Tissue Sarcoma |
|---|---|---|
| Comments | An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1. | |
| Type of Statistical Test | Superiority | |
| Comments | An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Binomial estimate of response rate of PR |
| Estimated Value | 17.5 | |
| Confidence Interval |
(2-Sided) 95% 7.3 to 32.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bone Sarcoma |
|---|---|---|
| Comments | An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Binomial estimate of response rate of PR |
| Estimated Value | 5.0 | |
| Confidence Interval |
(2-Sided) 95% 1.0 to 16.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Expansion Cohort |
|---|---|---|
| Comments | An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Binomial estimate of response rate of PR |
| Estimated Value | 13.0 | |
| Confidence Interval |
(2-Sided) 95% 5.5 to 25.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients | |
| Title | Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient |
|---|---|
| Description | Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product. |
| Time Frame | Up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion Cohort |
|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
| Measure Participants | 42 | 42 | 60 |
| Number [Grade 3 or higher treatment related AEs] |
6
|
9
|
10
|
| Title | The Progression-free Survival (PFS) |
|---|---|
| Description | The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. |
| Time Frame | up to 5 yrs |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion Cohort |
|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
| Measure Participants | 37 | 39 | 53 |
| Median (95% Confidence Interval) [weeks] |
18
|
8
|
8
|
| Title | Response Rate by Immune-related Response Criteria (Ir-RC) |
|---|---|
| Description | Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions |
| Time Frame | Assessment at 8 weeks, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort. |
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion Cohort |
|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
| Measure Participants | 30 | 30 | 52 |
| irCR |
1
2.4%
|
0
0%
|
2
3.3%
|
| irPR |
2
4.8%
|
2
4.8%
|
7
11.7%
|
| Title | Overall Survival (OS) |
|---|---|
| Description | The Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease and are still alive |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion Cohort |
|---|---|---|---|
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks |
| Measure Participants | 42 | 42 | 60 |
| Median (95% Confidence Interval) [weeks] |
49
|
52
|
57
|
Adverse Events
| Time Frame | Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Soft Tissue Sarcoma | Bone Sarcoma | Expansion | |||
| Arm/Group Description | Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks Pembrolizumab | Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks | |||
All Cause Mortality |
||||||
| Soft Tissue Sarcoma | Bone Sarcoma | Expansion | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/42 (9.5%) | 2/42 (4.8%) | 2/60 (3.3%) | |||
Serious Adverse Events |
||||||
| Soft Tissue Sarcoma | Bone Sarcoma | Expansion | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/42 (45.2%) | 15/42 (35.7%) | 17/60 (28.3%) | |||
| Cardiac disorders | ||||||
| Cardiac disorders, other | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Ventricular Tachycardia | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Endocrine disorders | ||||||
| Adrenal Insufficiency | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Eye disorders | ||||||
| Blurred Vision | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Duodenal Perforation | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Abdominal pain | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Ascites | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Colonic Obstruction | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Colonic Stenosis | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Ileus | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Pancreatitis | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| General disorders | ||||||
| Fatigue | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Fever | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| General Disorders and Administration site conditions | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 3/60 (5%) | 3 |
| Immune system disorders | ||||||
| Immune system disorders, other | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Infections and infestations | ||||||
| Sepsis | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| appendicitis | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Urinary Tract Infection | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Bone Pain | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Musculoskeletal and connective tissue disorder, other | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Myositis | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Neoplasms, benign, malignant and unspecified | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 2/60 (3.3%) | 2 |
| Nervous system disorders | ||||||
| Nervous system disorders, other | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Acute kidney inury | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Renal and urinary disorders, other | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Bronchopulmonary hemmorhage | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Dyspnea | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| Hypoxia | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Laryngeal hemmorrhage | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Pleural Effusion | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 1/60 (1.7%) | 1 |
| Pneumonitis | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Vascular disorders | ||||||
| Thromboembolic event | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Vascular disorders, other | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Soft Tissue Sarcoma | Bone Sarcoma | Expansion | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/42 (95.2%) | 42/42 (100%) | 58/60 (96.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 9/42 (21.4%) | 9 | 8/42 (19%) | 8 | 21/60 (35%) | 21 |
| Blood and Lymphatic Systems Disorder, other | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 2/60 (3.3%) | 2 |
| Febrile Neuropenia | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Leukocytosis | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 2/60 (3.3%) | 2 |
| Cardiac disorders | ||||||
| Cardiac disorders, other | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| palpitations | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Sinus Bradycardia | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Sinus Tachycardia | 2/42 (4.8%) | 2 | 2/42 (4.8%) | 2 | 4/60 (6.7%) | 4 |
| Ventricular Tachycardia | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Ear and labyrinth disorders | ||||||
| Ear and Labyrinth disorders, other | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Endocrine disorders | ||||||
| Endocrine Disorders-other | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Hyperparathyroidism | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Hyperthyroidism | 3/42 (7.1%) | 3 | 2/42 (4.8%) | 2 | 2/60 (3.3%) | 2 |
| Hypothyroidism | 2/42 (4.8%) | 2 | 2/42 (4.8%) | 2 | 7/60 (11.7%) | 7 |
| Eye disorders | ||||||
| Blurred vision | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| photophobia | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 5/42 (11.9%) | 5 | 1/42 (2.4%) | 1 | 5/60 (8.3%) | 5 |
| constipation | 5/42 (11.9%) | 5 | 6/42 (14.3%) | 6 | 6/60 (10%) | 6 |
| diarrhea | 7/42 (16.7%) | 7 | 2/42 (4.8%) | 2 | 6/60 (10%) | 6 |
| dry mouth | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 4/60 (6.7%) | 4 |
| flatulance | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| gastrointestinal disorders-other | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 4/60 (6.7%) | 4 |
| non-cardiac chest pain | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 0/60 (0%) | 0 |
| vaginal infection | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Dental caries | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Dyspepsia | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Gastric ulcer | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Gastritis | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| gastroesophogeal reflux | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| Mucositis oral | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Nausea | 10/42 (23.8%) | 10 | 3/42 (7.1%) | 3 | 9/60 (15%) | 9 |
| rectal pain | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Vomiting | 4/42 (9.5%) | 4 | 1/42 (2.4%) | 1 | 4/60 (6.7%) | 4 |
| General disorders | ||||||
| chills | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 5/60 (8.3%) | 5 |
| Edema limbs | 3/42 (7.1%) | 3 | 2/42 (4.8%) | 2 | 6/60 (10%) | 6 |
| Fatigue | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| flu like symptoms | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| general disorders-other | 1/42 (2.4%) | 1 | 3/42 (7.1%) | 3 | 5/60 (8.3%) | 5 |
| Hypothermia | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| localized edema | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 2/60 (3.3%) | 2 |
| malaise | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Pain | 1/42 (2.4%) | 1 | 2/42 (4.8%) | 2 | 0/60 (0%) | 0 |
| Immune system disorders | ||||||
| allergic reaction | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| serum sickness | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Infections and infestations | ||||||
| tooth infection | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| infections and infestations-other | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| papulopustular rash | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| skin infection | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| upper respiratory infection | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 4/60 (6.7%) | 4 |
| Injury, poisoning and procedural complications | ||||||
| Bruising | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| fracture | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 2/60 (3.3%) | 2 |
| Investigations | ||||||
| activated partial thromboplastin time prolonged | 6/42 (14.3%) | 6 | 7/42 (16.7%) | 7 | 8/60 (13.3%) | 8 |
| Alanine aminotranferase increased | 1/42 (2.4%) | 1 | 5/42 (11.9%) | 5 | 4/60 (6.7%) | 4 |
| Alkaline Phosphatase increased | 4/42 (9.5%) | 4 | 12/42 (28.6%) | 12 | 7/60 (11.7%) | 7 |
| Aspartate aminotransferase increased | 0/42 (0%) | 0 | 7/42 (16.7%) | 7 | 6/60 (10%) | 6 |
| creatinine increased | 2/42 (4.8%) | 2 | 2/42 (4.8%) | 2 | 5/60 (8.3%) | 5 |
| INR increased | 4/42 (9.5%) | 4 | 4/42 (9.5%) | 4 | 6/60 (10%) | 6 |
| Lymphocyte count decreased | 3/42 (7.1%) | 3 | 6/42 (14.3%) | 6 | 10/60 (16.7%) | 10 |
| Blood bilirubin increased | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| CPK increased | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 2/60 (3.3%) | 2 |
| investigations-other | 1/42 (2.4%) | 1 | 3/42 (7.1%) | 3 | 1/60 (1.7%) | 1 |
| lymphocyte count increased | 1/42 (2.4%) | 1 | 3/42 (7.1%) | 3 | 1/60 (1.7%) | 1 |
| neutrophil count decreased | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 1/60 (1.7%) | 1 |
| platelet count decreased | 1/42 (2.4%) | 1 | 3/42 (7.1%) | 3 | 3/60 (5%) | 3 |
| weight loss | 1/42 (2.4%) | 1 | 4/42 (9.5%) | 4 | 0/60 (0%) | 0 |
| white blood cell decreased | 1/42 (2.4%) | 1 | 4/42 (9.5%) | 4 | 0/60 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| dehydration | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 6/60 (10%) | 6 |
| hypercalcemia | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| hyperglycemia | 6/42 (14.3%) | 6 | 3/42 (7.1%) | 3 | 8/60 (13.3%) | 8 |
| hyperkalemia | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 3/60 (5%) | 3 |
| hypoalbumenia | 3/42 (7.1%) | 3 | 5/42 (11.9%) | 5 | 8/60 (13.3%) | 8 |
| hypocalcemia | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 4/60 (6.7%) | 4 |
| hypokalemia | 0/42 (0%) | 0 | 4/42 (9.5%) | 4 | 1/60 (1.7%) | 1 |
| hyponatremia | 5/42 (11.9%) | 5 | 8/42 (19%) | 8 | 8/60 (13.3%) | 8 |
| anorexia | 6/42 (14.3%) | 6 | 2/42 (4.8%) | 2 | 8/60 (13.3%) | 8 |
| Musculoskeletal and connective tissue disorders | ||||||
| arthralgia | 3/42 (7.1%) | 3 | 0/42 (0%) | 0 | 3/60 (5%) | 3 |
| back pain | 7/42 (16.7%) | 7 | 1/42 (2.4%) | 1 | 8/60 (13.3%) | 8 |
| chest wall pain | 3/42 (7.1%) | 3 | 3/42 (7.1%) | 3 | 1/60 (1.7%) | 1 |
| musculoskeletal and connective tissue disorder-other | 2/42 (4.8%) | 2 | 2/42 (4.8%) | 2 | 7/60 (11.7%) | 7 |
| pain in extremity | 3/42 (7.1%) | 3 | 4/42 (9.5%) | 4 | 6/60 (10%) | 6 |
| bone pain | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 2/60 (3.3%) | 2 |
| buttock pain | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| flank pain | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| generalized muscle weakness | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| joint effusion | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| joint range of motion decreased | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| myalgia | 4/42 (9.5%) | 4 | 1/42 (2.4%) | 1 | 2/60 (3.3%) | 2 |
| neck pain | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| soft tissue necrosis upper limb | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| tumor pain | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 2/60 (3.3%) | 2 |
| neoplasms, benign, malignant, and unspecified | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Nervous system disorders | ||||||
| dizziness | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| headache | 4/42 (9.5%) | 4 | 1/42 (2.4%) | 1 | 2/60 (3.3%) | 2 |
| nervous system disorders, other | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 0/60 (0%) | 0 |
| neuralgia | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| dysesthesia | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| dysgeusia | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Paresthesia | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| peripheral sensory neuropathy | 3/42 (7.1%) | 3 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| presyncope | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Psychiatric disorders | ||||||
| confusion | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| insomnia | 2/42 (4.8%) | 2 | 4/42 (9.5%) | 4 | 0/60 (0%) | 0 |
| anxiety | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 3/60 (5%) | 3 |
| depression | 2/42 (4.8%) | 2 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| psychiatric disorders-other | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| suicidal ideation | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Proteinuria | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| URINARY URGENCY | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| cough | 9/42 (21.4%) | 9 | 7/42 (16.7%) | 7 | 7/60 (11.7%) | 7 |
| dyspnea | 6/42 (14.3%) | 6 | 4/42 (9.5%) | 4 | 5/60 (8.3%) | 5 |
| Laryngeal hemmorhage | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| pleural effusion | 2/42 (4.8%) | 2 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| Postnasal drip | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 0/60 (0%) | 0 |
| respiratory, thoracic, and mediastinal disorders, other | 4/42 (9.5%) | 4 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| allergic rhinitis | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| pneumonitis | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 0/60 (0%) | 0 |
| productive cough | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| sore throat | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| erythmea multiforme | 1/42 (2.4%) | 1 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
| Pruritis | 3/42 (7.1%) | 3 | 1/42 (2.4%) | 1 | 6/60 (10%) | 6 |
| rash maculo-papular | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 7/60 (11.7%) | 7 |
| rash acneiform | 1/42 (2.4%) | 1 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| skin and subcutaneous tissue disorders | 5/42 (11.9%) | 5 | 1/42 (2.4%) | 1 | 3/60 (5%) | 3 |
| Vascular disorders | ||||||
| Hot flashes | 0/42 (0%) | 0 | 1/42 (2.4%) | 1 | 1/60 (1.7%) | 1 |
| Hypertension | 0/42 (0%) | 0 | 2/42 (4.8%) | 2 | 8/60 (13.3%) | 8 |
| Hypotension | 0/42 (0%) | 0 | 0/42 (0%) | 0 | 1/60 (1.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Research Manager |
|---|---|
| Organization | Sarcoma Alliance for Research Through Collaboration |
| Phone | 734-930-7600 |
| sarc@sarctrials.org |
- SARC028