Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery

• ClinicalTrials.gov Identifier: NCT03074318
• Recruitment Status: Terminated
• First Posted: March 8, 2017
• Results First Posted: April 29, 2022
• Last Update Posted: April 29, 2022
• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); EMD Serono
• Information provided by (Responsible Party): Seth Pollack, Northwestern University

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Metastatic Leiomyosarcoma; Metastatic Liposarcoma; Unresectable Leiomyosarcoma; Unresectable Liposarcoma
• Interventions: Drug: Avelumab; Drug: Trabectedin
• Enrollment: 35

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Phase 1 Dose Level 1	Phase 1 Dose Level 2	Phase 1 Dose Level 3	Phase 2
Arm/Group Description	Subjects received 1.5 mg/m^2 of trabectedin plus avelumab.	Subjects received 1.0 mg/m^2 of trabectedin plus avelumab	Subjects received 1.2 mg/m^2 of trabectedin plus avelumab.	Subjects received 1.0 mg/m^2 trabectedin plus avelumab.
Period Title: Overall Study
Started	6	7	6	16
Completed	2	2	0	0
Not Completed	4	5	6	16
Reason Not Completed
Adverse Event	0	1	1	1
Death	1	0	0	0
Withdrawal by Subject	1	2	2	4
Trial Closure	2	2	3	11

Baseline Characteristics

Arm/Group Title		Phase 1 (1.5 mg/m^2 Trabectedin)	Phase 1 (1.0 mg/m^2 Trabectedin)	Phase 1 (1.2 mg/m^2 Trabectedin)	Phase 2 (Avelumab, Trabectedin)	Total
Arm/Group Description		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	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	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	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	Total of all reporting groups
Overall Number of Baseline Participants		6	7	6	16	35
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	7 participants	6 participants	16 participants	35 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	4 66.7%	7 100.0%	4 66.7%	7 43.8%	22 62.9%
	>=65 years	2 33.3%	0 0.0%	2 33.3%	9 56.3%	13 37.1%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	7 participants	6 participants	16 participants	35 participants
	Female	1 16.7%	5 71.4%	3 50.0%	11 68.8%	20 57.1%
	Male	5 83.3%	2 28.6%	3 50.0%	5 31.3%	15 42.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	7 participants	6 participants	16 participants	35 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	6 100.0%	7 100.0%	6 100.0%	14 87.5%	33 94.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	2 12.5%	2 5.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	7 participants	6 participants	16 participants	35 participants
	American Indian or Alaska Native	0 0.0%	1 14.3%	0 0.0%	1 6.3%	2 5.7%
	Asian	0 0.0%	1 14.3%	1 16.7%	2 12.5%	4 11.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	6 100.0%	4 57.1%	5 83.3%	12 75.0%	27 77.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	1 14.3%	0 0.0%	1 6.3%	2 5.7%
Type of Sarcoma; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants	7 participants	6 participants	16 participants	35 participants
	Uterine Leiomyosarcoma	0 0.0%	3 42.9%	0 0.0%	3 18.8%	6 17.1%
	Non-Uterine Leiomyosarcoma	4 66.7%	2 28.6%	2 33.3%	10 62.5%	18 51.4%
	Dedifferentiated Liposarcoma	2 33.3%	1 14.3%	3 50.0%	3 18.8%	9 25.7%
	Myxoid/Round Cell Liposarcoma	0 0.0%	1 14.3%	0 0.0%	0 0.0%	1 2.9%
	Pleomorphic Liposarcoma	0 0.0%	0 0.0%	1 16.7%	0 0.0%	1 2.9%
Lines of Prior Therapy; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	6 participants	7 participants	6 participants	16 participants	35 participants
0 Lines of Prior Therapy		2 33.3%	0 0.0%	0 0.0%	3 18.8%	5 14.3%
1 Line of Prior Therapy		1 16.7%	1 14.3%	2 33.3%	8 50.0%	12 34.3%
2 Lines of Prior Therapy		2 33.3%	0 0.0%	2 33.3%	3 18.8%	7 20.0%
3 Lines of Prior Therapy		1 16.7%	1 14.3%	2 33.3%	1 6.3%	5 14.3%
4 Lines of Prior Therapy		0 0.0%	4 57.1%	0 0.0%	0 0.0%	4 11.4%
5 Lines of Prior Therapy		0 0.0%	1 14.3%	0 0.0%	1 6.3%	2 5.7%

Outcome Measures

1. Primary Outcome

Title	Incidence of Adverse Events
Description	Measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Time Frame	up to 2 years 7 months total

Outcome Measure Data

Analysis Population Description

Cumulative number of adverse events experienced on trial by all patients, reported per grade.

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	Subjects received 1.5 mg/m2 of trabectedin plus avelumab.	Subjects received 1.0 mg/m^2 trabectedin plus avelumab.	Subjects received 1.2 mg/m^2 trabectedin plus avelumab.	Subjects received 1.0 mg/m^2 trabectedin plus avelumab.
Overall Number of Participants Analyzed	6	7	6	16
Measure Type: Number; Unit of Measure: number of adverse events
Grade 1	95	98	86	201
Grade 2	41	46	33	115
Grade 3	12	14	9	40
Grade 4	2	0	0	6
Grade 5	1	0	0	0

2. Primary Outcome

Title	Overall Response Rate (ORR)
Description	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.
Time Frame	Up to 2 years 7 months total

Outcome Measure Data

Analysis Population Description

Subjects enrolled in Phase 2 plus subjects treated at the Recommended Phase 2 Dose (RP2D).

Arm/Group Title	Treatment (Avelumab, Trabectedin)
Arm/Group Description:	Subjects enrolled in Phase 2 plus subjects treated at the Recommended Phase 2 dose.
Overall Number of Participants Analyzed	23
Measure Type: Number; Unit of Measure: percentage of participants
	13

3. Secondary Outcome

Title	Time to Response
Description	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.
Time Frame	Up to 2 years 7 months total

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	1	0	0	3
Mean (Full Range); Unit of Measure: days
	158			189; (77 to 329)

4. Secondary Outcome

Title	Duration of Response
Description	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.
Time Frame	Up to 2 years 7 months total

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	1	0	0	3
Mean (Full Range); Unit of Measure: days
	NA [1]			NA [1]; (NA to NA)

[1]

Data not representative of actual duration of response due to low response rate overall, late time to response for 1 subject, and study closing early while subjects still responding.

5. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	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.
Time Frame	At 12 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	6	6	6	16
Measure Type: Number; Unit of Measure: percentage of participants
	50	50	83	63

6. Secondary Outcome

Title	Complete Response Rate (CR)
Description	Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response is defined as disappearance of all evaluable disease.
Time Frame	At 12 weeks

Outcome Measure Data

Analysis Population Description

NOTE: one subject was not evaluable for response and was replaced after withdrawing from study before response evaluation.

Arm/Group Title	Phase 1, 1.5 mg/m^2 Trabectedin	Phase 1, 1.0 mg/m^2 Trabectedin	Phase 1, 1.2 mg/m^2 Trabectedin	Phase 2, 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	6	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%

7. Secondary Outcome

Title	Partial Response Rate (PR)
Description	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.
Time Frame	At 12 weeks

Outcome Measure Data

Analysis Population Description

NOTE: One subject was not evaluable for response and was replaced after withdrawing from the study before response evaluation.

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	6	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	1 16.7%	0 0.0%	0 0.0%	3 18.8%

8. Secondary Outcome

Title	Stable Disease (SD)
Description	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).
Time Frame	At 12 weeks

Outcome Measure Data

Analysis Population Description

NOTE: one subject was not evaluable for response and was replaced after withdrawing from the study before response evaluation.

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	6	6	6	16
Measure Type: Count of Participants; Unit of Measure: Participants
	2 33.3%	3 50.0%	4 66.7%	7 43.8%

9. Secondary Outcome

Title	Clinical Benefit Rate
Description	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).
Time Frame	At 12 weeks

Outcome Measure Data

Analysis Population Description

Subjects with a Partial Response (PR) or Stable Disease (SD) treated at the RP2D. No subjects achieved a Complete Response (CR) while on study.

Arm/Group Title	Treatment (Avelumab, Trabectedin)
Arm/Group Description:	Subjects enrolled in Phase 2 plus subjects treated at the Recommended Phase 2 dose.
Overall Number of Participants Analyzed	23
Measure Type: Number; Unit of Measure: percentage of participants
	56

10. Secondary Outcome

Title	Median Overall Survival (OS)
Description	Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame	Up to 2 years post End of Treatment, for a total of 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	6	7	6	16
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: days
	391; (22 to 759)	416; (0 to 906)	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

The study was closed early when Principal Investigator left institution, so outcome was not reached for this cohort.

11. Secondary Outcome

Title	Adverse Event Profile - All Treatment-Related Grade 3-5 Adverse Events
Description	Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame	Up to 2 years 7 months total

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin	Phase 1 - 1.0 mg/m^2 Trabectedin	Phase 1 - 1.2 mg/m^2 Trabectedin	Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description:	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	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	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	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
Overall Number of Participants Analyzed	6	7	6	16
Measure Type: Number; Unit of Measure: Events
Alanine Aminotransferase Increased	1	1	1	3
Lymphocyte Count Decreased	0	0	0	4
Neutrophil Count Decreased	1	2	0	0
Anemia	0	0	0	2
Ejection Fraction Decreased	1	0	1	0
Aspartate Aminotransferase Increased	0	0	0	1
Blood Bilirubin Increased	1	0	0	0
Dyspnea	0	0	0	1
Fatigue	0	0	0	1
Gastrointestinal Disorders - Other	0	1	0	0
GGT Increased	1	0	0	0
Hepatobiliary Disorders - Other	1	0	0	0
Hypophosphatemia	1	0	0	0
Infections and Infestations - Other (Port Infection/Inflammation/Erythema)	1	0	0	0
Infusion Related Reaction	0	0	0	1
Muscle Weakness Lower Limb	0	0	0	1
Respiratory Failure	1	0	0	0
Syncope	1	0	0	0
White Blood Cell Decreased	1	0	0	0

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Phase 1 - 1.5 mg/m^2 Trabectedin		Phase 1 - 1.0 mg/m^2 Trabectedin		Phase 1 - 1.2mg/m^2 Trabectedin		Phase 2 - 1.0 mg/m^2 Trabectedin
Arm/Group Description	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		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 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 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
All-Cause Mortality
	Phase 1 - 1.5 mg/m^2 Trabectedin		Phase 1 - 1.0 mg/m^2 Trabectedin		Phase 1 - 1.2mg/m^2 Trabectedin		Phase 2 - 1.0 mg/m^2 Trabectedin
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	4/6 (66.67%)		5/7 (71.43%)		2/6 (33.33%)		1/16 (6.25%)
Serious Adverse Events
	Phase 1 - 1.5 mg/m^2 Trabectedin		Phase 1 - 1.0 mg/m^2 Trabectedin		Phase 1 - 1.2mg/m^2 Trabectedin		Phase 2 - 1.0 mg/m^2 Trabectedin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.33%)		2/7 (28.57%)		1/6 (16.67%)		7/16 (43.75%)
Blood and lymphatic system disorders
Febrile neutropenia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Cardiac disorders
Tricuspid valve disease † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Gastrointestinal disorders
Gastrointestinal disorders - other † 1 [1]	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Gastrointestinal disorders - other † 1 [2]	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Abdominal Pain † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Rectal hemorrhage † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Upper gastrointestinal hemorrhage † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Gastrointestinal disorders - other † 1 [3]	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Gastrointestinal disorders - other † 1 [4]	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
General disorders
Fever † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Hepatobiliary disorders
LFT Elevation † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Infections and infestations
Enterocolitis infectious † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Urinary tract infection † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Biliary tract infection † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tricuspid valve mass † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Tumor Pain † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Nervous system disorders
Seizure † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Syncope † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	2/16 (12.50%)	2
Respiratory failure † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Hypoxia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Pleural effusion † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Pneumothorax † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Vascular disorders
Hypotension † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Pulmonary Embolism † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
1 Term from vocabulary, CTCAE (5.0); † Indicates events were collected by systematic assessment; [1] Small intestinal obstruction; [2] Acute Diverticulitis; [3] Hematemesis; [4] Melena
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Phase 1 - 1.5 mg/m^2 Trabectedin		Phase 1 - 1.0 mg/m^2 Trabectedin		Phase 1 - 1.2mg/m^2 Trabectedin		Phase 2 - 1.0 mg/m^2 Trabectedin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100.00%)		7/7 (100.00%)		6/6 (100.00%)		16/16 (100.00%)
Blood and lymphatic system disorders
Anemia † 1	0/6 (0.00%)	0	1/7 (14.29%)	2	1/6 (16.67%)	1	6/16 (37.50%)	11
Leukocytosis † 1	2/6 (33.33%)	2	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Cardiac disorders
Palpitations † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	3/16 (18.75%)	3
Sinus tachycardia † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Chest Pain - Cardiac † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Ventricular arrhythmia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Tricuspid Valve Disease † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Cardiac Disorders - Other † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Ear and labyrinth disorders
Tinnitus † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Endocrine disorders
Hypothyroidism † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	3/16 (18.75%)	4
Hyperparathyroidism † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Endocrine Disorders - Other † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Eye disorders
Blurred Vision † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	2	2/16 (12.50%)	2
Dry eye † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Floaters † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	2/16 (12.50%)	2
Watering Eyes † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Eye Disorders - Other † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Gastrointestinal disorders
Nausea † 1	6/6 (100.00%)	8	5/7 (71.43%)	5	3/6 (50.00%)	3	13/16 (81.25%)	14
Diarrhea † 1	5/6 (83.33%)	5	4/7 (57.14%)	10	4/6 (66.67%)	6	6/16 (37.50%)	7
Vomiting † 1	5/6 (83.33%)	7	2/7 (28.57%)	4	3/6 (50.00%)	4	8/16 (50.00%)	9
Constipation † 1	1/6 (16.67%)	1	3/7 (42.86%)	3	4/6 (66.67%)	6	5/16 (31.25%)	5
Abdominal Pain † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	2/6 (33.33%)	3	3/16 (18.75%)	4
Gastroesophageal reflux disease † 1	1/6 (16.67%)	1	2/7 (28.57%)	2	1/6 (16.67%)	1	1/16 (6.25%)	1
Dry Mouth † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	1/16 (6.25%)	1
Oral pain † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	2/16 (12.50%)	2
Flatulence † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Stomach Pain † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	2/6 (33.33%)	2	0/16 (0.00%)	0
Mucositis oral † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	1
Rectal hemorrhage † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Active Diverticulitis † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Dyspepsia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Gastrointestinal disorders - other † 1 [1]	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Ascites † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Toothache † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Colitis † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Colonic obstruction † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
General disorders
Fatigue † 1	6/6 (100.00%)	8	6/7 (85.71%)	6	5/6 (83.33%)	6	16/16 (100.00%)	19
Pain † 1	4/6 (66.67%)	6	2/7 (28.57%)	4	0/6 (0.00%)	0	4/16 (25.00%)	4
Flu like symptoms † 1	1/6 (16.67%)	1	3/7 (42.86%)	6	0/6 (0.00%)	0	1/16 (6.25%)	1
Fever † 1	2/6 (33.33%)	3	2/7 (28.57%)	3	0/6 (0.00%)	0	3/16 (18.75%)	8
Chills † 1	1/6 (16.67%)	2	2/7 (28.57%)	3	1/6 (16.67%)	1	1/16 (6.25%)	1
Non-cardiac chest pain † 1	1/6 (16.67%)	2	2/7 (28.57%)	3	0/6 (0.00%)	0	1/16 (6.25%)	1
Edema limbs † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	1/6 (16.67%)	1	2/16 (12.50%)	3
Soreness † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Localized edema † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Pyrosis † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Body Aches † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Immune system disorders
Urinary Tract Infection † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Infections and infestations
Upper Respiratory Infection † 1	2/6 (33.33%)	2	1/7 (14.29%)	1	1/6 (16.67%)	1	1/16 (6.25%)	1
Dry Skin † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	3/16 (18.75%)	3
Infections and infestations - Other † 1 [2]	3/6 (50.00%)	3	3/7 (42.86%)	3	3/6 (50.00%)	3	4/16 (25.00%)	5
Sinusitis † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	1/6 (16.67%)	1	0/16 (0.00%)	0
Skin Infection † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Enterocolitis infectious † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Lip Infection † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Biliary tract infection † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Infective myositis † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Enterocolitis infectious † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Urinary tract infection † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Injury, poisoning and procedural complications
Infusion related reaction † 1	2/6 (33.33%)	2	2/7 (28.57%)	2	2/6 (33.33%)	2	8/16 (50.00%)	12
Bruising † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	3/16 (18.75%)	3
Wound complication † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Fracture † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Investigations
Alanine aminotransferase increase † 1	3/6 (50.00%)	5	1/7 (14.29%)	2	5/6 (83.33%)	7	6/16 (37.50%)	19
Aspartate aminotransferase increased † 1	3/6 (50.00%)	4	0/7 (0.00%)	0	1/6 (16.67%)	1	5/16 (31.25%)	9
Lymphocyte count decreased † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	11/16 (68.75%)	20
Creatinine Increaed † 1	2/6 (33.33%)	3	1/7 (14.29%)	1	0/6 (0.00%)	0	3/16 (18.75%)	5
Alkaline Phosphatase Increased † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	2/16 (12.50%)	9
Weight loss † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	3/16 (18.75%)	4
Neutrophil count decreased † 1	1/6 (16.67%)	1	3/7 (42.86%)	9	0/6 (0.00%)	0	1/16 (6.25%)	2
Platelet count decreased † 1	2/6 (33.33%)	2	0/7 (0.00%)	0	1/6 (16.67%)	6	2/16 (12.50%)	4
White blood cell decreased † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	2/16 (12.50%)	4
Ejection fraction decreased † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	2/6 (33.33%)	3	0/16 (0.00%)	0
CPK increased † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	1
Cardiac troponin I increased † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
INR Increased † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Blood bilirubin increased † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
GGT increased † 1	1/6 (16.67%)	2	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Investigations - Other † 1	2/6 (33.33%)	2	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Hypophosphatemia † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Hypoglycemia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Hyponatremia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Metabolism and nutrition disorders
Anorexia † 1	3/6 (50.00%)	3	4/7 (57.14%)	4	5/6 (83.33%)	6	8/16 (50.00%)	8
Hypokalemia † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	2/16 (12.50%)	2
Hypocalcemia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	4/16 (25.00%)	4
Dehydration † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Hypoalbuminemia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	2/16 (12.50%)	2
Musculoskeletal and connective tissue disorders
Bone Pain † 1	2/6 (33.33%)	2	3/7 (42.86%)	3	2/6 (33.33%)	2	6/16 (37.50%)	6
Myalgia † 1	2/6 (33.33%)	2	1/7 (14.29%)	1	3/6 (50.00%)	5	5/16 (31.25%)	5
Generalized muscle weakness † 1	3/6 (50.00%)	3	0/7 (0.00%)	0	1/6 (16.67%)	1	2/16 (12.50%)	3
Pain in extremity † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	1/6 (16.67%)	1	2/16 (12.50%)	3
Arthralgia † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Neck Pain † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Back Pain † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	1
Muscle Cramp † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	2/16 (12.50%)	2
Left Total Hip Dislocation † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Musculoskeletal and connective tissue disorders - other † 1	2/6 (33.33%)	2	4/7 (57.14%)	4	0/6 (0.00%)	0	0/16 (0.00%)	0
Chest Wall Pain † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	1/6 (16.67%)	2	1/16 (6.25%)	3
Sebaceous Cyst † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Nervous system disorders
Headache † 1	2/6 (33.33%)	2	2/7 (28.57%)	3	3/6 (50.00%)	3	4/16 (25.00%)	7
Dysgeusia † 1	3/6 (50.00%)	3	2/7 (28.57%)	2	2/6 (33.33%)	2	4/16 (25.00%)	4
Dizziness † 1	3/6 (50.00%)	3	1/7 (14.29%)	2	2/6 (33.33%)	3	2/16 (12.50%)	2
Nervous System Disorders - Other † 1	2/6 (33.33%)	3	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Tremor † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	3/16 (18.75%)	3
Paresthesia † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	1/6 (16.67%)	1	0/16 (0.00%)	0
Syncope † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Extrapyramidal disorder † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Cognitive disturbance † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	1/6 (16.67%)	1	0/16 (0.00%)	0
Presyncope † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Radiculitis † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Lethargy † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Peripheral sensory neuropathy † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Hallucinations † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Confusion † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Concentration impairment † 1	2/6 (33.33%)	2	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Neuralgia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Psychiatric disorders
Insomnia † 1	2/6 (33.33%)	2	2/7 (28.57%)	2	2/6 (33.33%)	2	2/16 (12.50%)	2
Anxiety † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	1
Depression † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	2	1/16 (6.25%)	1
Psychiatric disorders - Other † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Renal and urinary disorders
Urinary frequency † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	1/6 (16.67%)	1	1/16 (6.25%)	1
Renal and urinary disorders - Other † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	1
Urinary tract obstruction † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Acute Kidney Injury † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Hematuria † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Reproductive system and breast disorders
Irregular menstruation † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Pelvic Pain † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	4/6 (66.67%)	4	0/7 (0.00%)	0	2/6 (33.33%)	3	5/16 (31.25%)	10
Cough † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	2/6 (33.33%)	4	4/16 (25.00%)	4
Postnasal drip † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Hoarseness † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Sore throat † 1	1/6 (16.67%)	1	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
Rhinorrhea † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Wheezing † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	1
Allergic rhinitis † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	2/16 (12.50%)	2
Hypoxia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Pleural effusion † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Bronchospasm † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Pulmonary edema † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Nasal congestion † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Pneumothorax † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Respiratory failure † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Epistaxis † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Skin and subcutaneous tissue disorders
Pruritus † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	2/6 (33.33%)	3	4/16 (25.00%)	5
Hyperhidrosis † 1	2/6 (33.33%)	2	1/7 (14.29%)	2	1/6 (16.67%)	1	0/16 (0.00%)	0
Rash acneiform † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	3/16 (18.75%)	3
Skin and subcutaneous tissue disorders - Other † 1	3/6 (50.00%)	3	3/7 (42.86%)	3	0/6 (0.00%)	0	1/16 (6.25%)	1
Pain of skin † 1	1/6 (16.67%)	2	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Rash maculo-papular † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	1/16 (6.25%)	3
Skin Hyperpigmentation † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Alopecia † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Skin Hypopigmentation † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Erythema multiforme † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	0/6 (0.00%)	0	1/16 (6.25%)	1
Photosensitivity † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Burn † 1	1/6 (16.67%)	1	0/7 (0.00%)	0	0/6 (0.00%)	0	0/16 (0.00%)	0
Scalp Pain † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	0/16 (0.00%)	0
Surgical and medical procedures
Surgical and Medical Procedures - Other † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	2/6 (33.33%)	2	1/16 (6.25%)	1
Vascular disorders
Hot flashes † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	3/16 (18.75%)	3
Hypotension † 1	2/6 (33.33%)	2	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Thromboembolic event † 1	0/6 (0.00%)	0	2/7 (28.57%)	2	0/6 (0.00%)	0	1/16 (6.25%)	1
Hematoma † 1	0/6 (0.00%)	0	0/7 (0.00%)	0	1/6 (16.67%)	1	1/16 (6.25%)	1
Vascular disorders - other † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	1/16 (6.25%)	2
Flushing † 1	0/6 (0.00%)	0	1/7 (14.29%)	1	0/6 (0.00%)	0	0/16 (0.00%)	0
1 Term from vocabulary, CTCAE (5.0); † Indicates events were collected by systematic assessment; [1] Heartburn; [2] Port complications

Limitations and Caveats

[Not Specified]

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: Seth Pollack, MD, Director of Sarcoma Program
• Organization: Northwestern University
• Phone: 312-503-5320
• EMail: seth.pollack@northwestern.edu

• Responsible Party: Seth Pollack, Northwestern University
• ClinicalTrials.gov Identifier: NCT03074318
• Other Study ID Numbers: 9717; 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 ); RG9217009 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
• First Submitted: March 1, 2017
• First Posted: March 8, 2017
• Results First Submitted: November 10, 2021
• Results First Posted: April 29, 2022
• Last Update Posted: April 29, 2022