Trial Outcomes & Findings for Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma (NCT NCT01495988)

NCT ID: NCT01495988

Last Updated: 2017-10-24

Results Overview

To establish the maximum tolerated dose (MTD) of bevacizumab in combination with vemurafenib and cobimetinib.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Until MTD determined (up to 6 months)

Results posted on

2017-10-24

Participant Flow

Eight subjects were randomized under protocol v2.0 with the first subject enrolled on 8/13/2013. Two subjects were enrolled under protocol v4.0 with the first subject enrolled on 6/19/2015. The study was permanently closed on 6/13/2016. All subjects were recruited from Melanoma Research Foundation Breakthrough Consortium (MRFBC) clinical sites.

Participants has to meet the eligibility criteria prior to enrollment into the study.

Participant milestones

Participant milestones
Measure	Vemurafenib/Cobimetinib + Bevacizumab Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor. Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks. Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle. Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression.	Vemurafenib Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients. Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter.	Vemurafenib + Bevacizumab Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients. Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks. Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter.
Vem +/- Bev (Protocol v2.0) STARTED	0	5	3
Vem +/- Bev (Protocol v2.0) COMPLETED	0	5	3
Vem +/- Bev (Protocol v2.0) NOT COMPLETED	0	0	0
Vem/Cobi +/- Bev (Protocol v4.0) STARTED	2	0	0
Vem/Cobi +/- Bev (Protocol v4.0) COMPLETED	2	0	0
Vem/Cobi +/- Bev (Protocol v4.0) NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vemurafenib/Cobimetinib Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor. Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle. Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression.	Vemurafenib/Cobimetinib + Bevacizumab n=2 Participants Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor. Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks. Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle. Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression.	Vemurafenib n=5 Participants Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients. Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter.	Vemurafenib + Bevacizumab n=3 Participants Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients. Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks. Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	4 Participants n=36 Participants
Age, Categorical >=65 years	—	2 Participants n=4 Participants	4 Participants n=27 Participants	0 Participants n=483 Participants	6 Participants n=36 Participants
Sex: Female, Male Female	—	1 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants
Sex: Female, Male Male	—	1 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	2 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	9 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	—	2 Participants n=4 Participants	5 Participants n=27 Participants	3 Participants n=483 Participants	10 Participants n=36 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	—	2 Participants n=4 Participants	5 Participants n=27 Participants	3 Participants n=483 Participants	10 Participants n=36 Participants

PRIMARY outcome

Timeframe: Until MTD determined (up to 6 months)

Population: The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed. MTD could not be determined.

To establish the maximum tolerated dose (MTD) of bevacizumab in combination with vemurafenib and cobimetinib.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Time between randomization and disease progression (~10-15 months)

Population: The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.

To compare median progression-free survival (PFS) of patients with stage IV, BRAFV600E or BRAFV600K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time between randomization and death due to any cause (overall survival rates also to be assessed at 12 and 18 months)

Population: The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.

Compare overall survival (OS) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of randomization to time of disease progression (restaging for tumor response to occur every 8 wks until wk 48, then every 12 wks thereafter)

Population: The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.

Compare response rate (RR) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until study completion

Population: The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.

Describe the toxicity and safety profile of treatment with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab in patients with stage IV, BRAFV600E/K melanoma.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Upon completion of the protocol (3 years)

Population: The trial was terminated prematurely and outcome measures were not analyzed.

Perform a variety of correlative studies aimed at understanding the effects of vemurafenib/cobimetinib, and bevacizumab administration relative to vemurafenib/cobimetinib on tumor angiogenesis, resistance mechanisms and immune function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Upon completion of the protocol (3 years)

Population: The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.

Assess the effectiveness of blood reverse transcription polymerase chain reaction (RT-PCR) assay for BRAFV600 as a surrogate biomarker for tumor response and resistance in patients receiving vemurafenib/cobimetinib +/- bevacizumab.

Outcome measures

Outcome data not reported

Adverse Events

Vemurafenib/Cobimetinib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vemurafenib/Cobimetinib + Bevacizumab

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Vemurafenib

Serious events: 3 serious events

Other events: 4 other events

Deaths: 5 deaths

Vemurafenib + Bevacizumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Vemurafenib/Cobimetinib Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor. Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle. Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression.	Vemurafenib/Cobimetinib + Bevacizumab n=2 participants at risk Vemurafenib: Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor. Bevacizumab: Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks. Cobimetinib: Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle. Patients will be assessed for toxicity every 4 weeks and be restaged for tumor response/progression every 8 weeks until week 48, then every 12 weeks thereafter. Patients will be followed until disease progression.	Vemurafenib n=5 participants at risk Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients. Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter.	Vemurafenib + Bevacizumab n=3 participants at risk Vemurafenib will be given at a dose of 960 mg p.o. BID to all patients. Patients assigned to the combination arm will also receive bevacizumab 15 mg/kg every IV every 3 weeks. Patients will be assessed for toxicity every 3 or 6 weeks (depending on the specific toxicity) and be restaged for tumor response/progression every 6 weeks until week 48, then every 12 weeks thereafter.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/2 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	20.0% 1/5 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Cardiac disorders Myocardial Infarction	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/2 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	20.0% 1/5 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Gastrointestinal disorders Incarcerated right femoral hernia	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/2 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	20.0% 1/5 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Gastrointestinal disorders Small Intestinal Obstruction	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/2 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	20.0% 1/5 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Infections and infestations Sepsis	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/2 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	20.0% 1/5 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Gastrointestinal disorders Diarrhea	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	100.0% 2/2 • Number of events 2 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/5 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Gastrointestinal disorders Vomiting	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	50.0% 1/2 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/5 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Renal and urinary disorders Acute Kidney Injury	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	50.0% 1/2 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/5 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
General disorders Multi-Organ Failure	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	50.0% 1/2 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/5 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)
Gastrointestinal disorders Retroperitoneal Hemorrhage	— 0/0 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	50.0% 1/2 • Number of events 1 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/5 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)	0.00% 0/3 • Adverse Event data were collected from time of first study drug administration through 30 days following the last administration of study drug or study discontinuation/termination, whichever is earlier. Safety assessments will consist of monitoring and reporting the following adverse events (AEs): * Serious adverse events * Events that lead to drug discontinuation or interruption * All grade 3 and 4 toxicities * All deaths * Adverse events of special interest (AESI)

Other adverse events

Additional Information

Damon Collie

The Emmes Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place