Trial Outcomes & Findings for Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma (NCT NCT02428192)

Last Updated: 2025-02-25

Results Overview

For the primary endpoint of overall response with a null hypothesis of 5% and an alternative hypothesis of 20%, 37 patients are needed in a two-stage design with 12 patients in the first stage and 25 patients in the second stage. At the first stage analysis, overall response, at least 1 response out of 12 patients will need to be observed to continue through the second stage. At the second stage, at least 4 responses out of 37 patients will need to be observed to accept the treatment. The overall power for overall response rate is 90%. The overall type I error, the chance of incorrectly rejecting the null hypothesis is 9%. The probability of stopping at the first stage under the null hypothesis is 54%. The operating characteristics of this design are calculated using the exact binomial distribution.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to 100 days

Results posted on

2025-02-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	12	8
Overall Study COMPLETED	0	7
Overall Study NOT COMPLETED	12	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=12 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) n=8 Participants Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Total n=20 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	61 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 100 days

Population: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=12 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Objective Response Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Among Patients With Advanced Leiomyosarcoma of the Uterus (ULMS) Treated With Nivolumab (Cohort A)	0 Participants	—

PRIMARY outcome

Timeframe: Up to 100 days

For the primary endpoint of overall response with a null hypothesis of 5% and an alternative hypothesis of 30%, 25 patients are needed in a two-stage design with 8 patients in the first stage and 17 patients in the second stage. At the first stage analysis, overall response, at least 1 response out of 8 patients will need to be observed to continue through the second stage. At the second stage, at least 3 responses out of 25 patients will need to be observed to accept the treatment. The overall power for overall response rate is 94%. The overall type I error, the chance of incorrectly rejecting the null hypothesis is 9%. The probability of stopping at the first stage under the null hypothesis is 66%. The operating characteristics of this design are calculated using the exact binomial distribution.

Outcome measures

Outcome measures
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=8 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Objective Response Per RECIST 1.1 Among Patients With Advanced ULMS Treated With Nivolumab and Ipilimumab (Cohort B)	0 Participants	—

SECONDARY outcome

Timeframe: Up to 4 cycles

Population: Please see the adverse events module for detailed list of adverse events. Percentage of participants who experienced an adverse event.

Among the first phase of 12 patients, there is at least 58% probability of observing one or more rare (7% true probability) events, and 83% probability of observing toxicities that have a true occurrence of at least 15%. Among the total cohort of 37 patients, there is at least 85% probability of observing one or more rare (5% true probability) events, and 95% probability of observing toxicities that have a true occurrence of at least 8%. With 37 treated patients, the maximum width of a 90% two-sided exact binomial confidence interval for any estimated adverse event proportion will be no wider than +/- 14%.

Outcome measures

Outcome measures
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=12 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Incidence of Toxicity, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Version 5.0 Beginning April 1, 2018) (Cohort A)	12 Participants	—

SECONDARY outcome

Timeframe: Up to 4 cycles

Population: Please refer to adverse event module for detailed list of adverse events. Percentage of participants who experienced adverse events.

Among the first phase of 8 patients, there is at least 57% probability of observing one or more rare (10% true probability) events, and 73% probability of observing one or more toxicities that have a true occurrence rate as low as 15%. Among the total cohort of 25 patients, there is at least 84% probability of observing one or more rare (7% true probability) events, and 93% probability of observing toxicities that have a true occurrence of at least 10%. With 25 treated patients, the maximum width of a 90% two-sided exact binomial confidence interval for any estimated adverse event proportion will be no wider than +/- 18%.

Outcome measures

Outcome measures
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=8 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Incidence of Toxicity, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Version 5.0 Beginning April 1, 2018) (Cohort B)	8 Participants	—

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 weeks

Population: Progression is defined as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

A null hypothesis of 20% and an alternative hypothesis of 40% at 12 weeks will be investigated. Patients lost to follow-up or deaths within 12 weeks will be counted as failures. The overall power for overall progression-free rate at 12 weeks is 87%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.

Outcome measures

Outcome measures
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=12 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Rate of Progression-free Survival (Cohort A)	1.8 months Interval 0.8 to The upper limit for the confidence interval on median PFS is unknown because the upper confidence limit for the PFS curve never reached 0.50 hence no upper limit for the median PFS exists.	—

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months

A null hypothesis of 18% and an alternative hypothesis of 40% at 6 months will be investigated. Patients lost to follow-up or deaths within 6 months will be counted as failures. The overall power for overall progression-free rate at 6 months is 85%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.

Outcome measures

Outcome measures
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=8 Participants Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Rate of Progression-free Survival (Cohort B)	2.0 months Interval 0.9 to 2.1	—

SECONDARY outcome

Timeframe: Up to 100 days

Population: to few responders to analyze biomarker data

The relationship between PDL1 status and response to nivolumab will be explored. A Fisher's exact test will be used to assess the relationship between each biomarker and response to treatment. The power to detect the relationship of interest increases as the prevalence of the biomarker increases.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

The relationship between PD2 status in archival tumor and response to nivolumab will be explored. A Fisher's exact test will be used to assess the relationship between each biomarker and response to treatment. The power to detect the relationship of interest increases as the prevalence of the biomarker increases. Analysis is pending.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 100 days

The relationship between PD1 in infiltrating lymphocytes and response to nivolumab will be explored. A Fisher's exact test will be used to assess the relationship between each biomarker and response to treatment. The power to detect the relationship of interest increases as the prevalence of the biomarker increases. Analysis is pending.

Outcome measures

Outcome data not reported

Adverse Events

Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Cohort B (Nivolumab and Ipilimumab)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) n=12 participants at risk Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Cohort B (Nivolumab and Ipilimumab) n=8 participants at risk Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.5% 1/8 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Investigations Serum amylase increased	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Investigations Lipase increased	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
General disorders Fatigue	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Diarrhea	0.00% 0/12 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.5% 1/8 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Investigations White blood cell decreased	0.00% 0/12 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.5% 1/8 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 2/12 • Number of events 2 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.5% 1/8 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Small Intestinal Obstruction	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Renal and urinary disorders Hematuria	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Psychiatric disorders Major Depression	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Renal Colic	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
General disorders Surgical Procedures (debulking/palliative surgery)	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Cardiac disorders Cardiopulmonary arrest	8.3% 1/12 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	0.00% 0/8 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Gastrointestinal disorders Small Bowel Obstruction	0.00% 0/12 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.	12.5% 1/8 • Number of events 1 • Up to 4 cyles Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.

Other adverse events

Additional Information

Dr. Suzanne George

DFCI

Phone: 617-632-5204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60