Trial Outcomes & Findings for A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer (NCT NCT03981146)
NCT ID: NCT03981146
Last Updated: 2026-04-22
Results Overview
patient will be defined as experiencing DCB if they remain free of disease progression at their third trial specific CT scan since treatment start date (i.e. at approximately 27 weeks) or at any CT scan after 27 weeks that shows the patient remains free of disease progression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Beginning of trial treatment to free of disease progression (104 weeks maximum)
Results posted on
2026-04-22
Participant Flow
Participant milestones
| Measure |
Nivolumab
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
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|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nivolumab
n=35 Participants
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
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|---|---|
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Age, Continuous
|
63 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=35 Participants
|
|
Primary Cancer Stage
Ascending colon
|
4 Participants
n=35 Participants
|
|
Primary Cancer Stage
Descending colon
|
3 Participants
n=35 Participants
|
|
Primary Cancer Stage
Transverse colon
|
2 Participants
n=35 Participants
|
|
Primary Cancer Stage
Sigmoid colon
|
14 Participants
n=35 Participants
|
|
Primary Cancer Stage
Rectum
|
12 Participants
n=35 Participants
|
|
Primary Resection Performed
No
|
7 Participants
n=35 Participants
|
|
Primary Resection Performed
Yes
|
28 Participants
n=35 Participants
|
|
RAS Mutations
KRAS
|
16 Participants
n=35 Participants
|
|
RAS Mutations
NRAS
|
3 Participants
n=35 Participants
|
|
RAS Mutations
BRAF
|
1 Participants
n=35 Participants
|
|
RAS Mutations
Not Known
|
15 Participants
n=35 Participants
|
|
Previous Lines of Therapy
|
6 Number of Lines of Therapy
n=35 Participants
|
|
ECOG Performance Status
0
|
11 Participants
n=35 Participants
|
|
ECOG Performance Status
1
|
23 Participants
n=35 Participants
|
|
ECOG Performance Status
Not Known
|
1 Participants
n=35 Participants
|
|
Smoking Status
Never smoked
|
22 Participants
n=35 Participants
|
|
Smoking Status
Ex-smoker
|
12 Participants
n=35 Participants
|
|
Smoking Status
Current smoker
|
1 Participants
n=35 Participants
|
|
Smoking Pack Years
|
5 Pack Years
n=35 Participants
|
|
Smoking Stopped Years
|
30 Years
n=10 Participants • This measure only applies to patients who are ex-smokers (12 patients), however, only 10 patients provided this data. Patients who never smoked or currently smoke are not included - see baseline characteristic "Smoking Status".
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PRIMARY outcome
Timeframe: Beginning of trial treatment to free of disease progression (104 weeks maximum)patient will be defined as experiencing DCB if they remain free of disease progression at their third trial specific CT scan since treatment start date (i.e. at approximately 27 weeks) or at any CT scan after 27 weeks that shows the patient remains free of disease progression
Outcome measures
| Measure |
Nivolumab
n=35 Participants
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
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|---|---|
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Durable Clinical Benefit
DCB
|
3 Participants
|
|
Durable Clinical Benefit
Non-DCB
|
32 Participants
|
SECONDARY outcome
Timeframe: Trial treatment until disease progression (104 weeks maximum)Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT scan, objective response is the occurrence of Complete Response (CR) or Partial Response (PR) as the best overall response. Best overall response is the combined evaluation of target and non-target lesions, as provided in the protocol appendix 3. Target lesions are evaluated as Complete Response (CR; disappearance of all target lesions), Partial Response (PR; \>=30% decrease in the sum of the longest diameter), Progressive Disease (PD; \>=20% increase in the sum of the longest diameter) or Stable Disease (SD; insufficient shrinkage for PR or insufficient increase for PD). Non-target lesions are evaluated as Complete Response (CR; disappearance of all non-target lesions), Incomplete Response/Stable Disease (SD; persistence of non-target lesions) or Progressive Disease (PD; new lesions and/or progression of existing non-target lesions).
Outcome measures
| Measure |
Nivolumab
n=35 Participants
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
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|---|---|
|
Objective Response
Objective Response Not Achieved
|
35 Participants
|
|
Objective Response
Objective Response Achieved
|
0 Participants
|
SECONDARY outcome
Timeframe: Trial Treatment to disease progression (104 weeks maximum)Population: Of 35 patients, 30 had CT scans following their baseline assessment. The remaining 5 patients only reported target lesion sizes at baseline, so the Best Percentage Change in Sum of Target Lesions could not be evaluated.
At each evaluation, the longest diameters of all selected target lesions will be measured and summed and the percentage change from the baseline measurement will be calculated. The best percentage change is the one that reflects either the greatest decrease or the least increase over the whole period of assessment.
Outcome measures
| Measure |
Nivolumab
n=30 Participants
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
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|---|---|
|
Best Percentage Change in Sum of Target Lesions
|
21.1 % change
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Occurrence of CR or PR during the trial (104 weeks maximum)Population: No patients recruited to the study reported having achieved either a Complete Response (CR) or Partial Response (PR). As such, this outcome definition was not met, and can not be analysed.
Time to maximal response was defined to be the time from commencement of trial treatment to the date of CT/MRI that first records objective response as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1. Objective response is the occurrence of Complete Response (CR) or Partial Response (PR) as patient's best overall response (see Secondary Outcome: Objective Response).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time from commencement of trial treatment to the date of CT scan when progressive disease first recorded (104 weeks maximum)This is defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded or date of death without previously recorded progression.first records the best objective response as per RECIST version 1.1.
Outcome measures
| Measure |
Nivolumab
n=35 Participants
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
|
|---|---|
|
Progression Free Survival Time
|
9.0 Weeks
Interval 8.7 to 9.7
|
SECONDARY outcome
Timeframe: Commencement of trial treatment until date of death; minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.This is defined as the time from commencement of trial treatment to the date of death from any cause.
Outcome measures
| Measure |
Nivolumab
n=35 Participants
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
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|---|---|
|
Overall Survival Time
|
7.2 Months
Interval 4.0 to 11.9
|
Adverse Events
Nivolumab
Serious events: 25 serious events
Other events: 35 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Nivolumab
n=35 participants at risk
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.1%
6/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Ascites
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Colonic obstruction
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Fever
|
11.4%
4/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Malaise
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Fever
|
2.9%
1/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Infection
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Infection secondary to Picc Line
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Peritoneal infection
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Blood bilirubin increased
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Creatinine increased
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Musculoskeletal and connective tissue disorders
Pelvic Pain
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Nervous system disorders
Seizure
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Psychiatric disorders
Confusion
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • Number of events 1 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
Other adverse events
| Measure |
Nivolumab
n=35 participants at risk
Nivolumab will be administered as a 60 minute IV infusion, with a window of -5 and +10 minutes, at a flat dose of 480mg. A dosing interval every 4 weeks (Q4W) was employed. Patients could receive nivolumab for a maximum of 2 years, or until disease progression, unacceptable toxicity ot withdrawal of consent. With the first dose, cycle 1 day 1, to be given within 7 days of registration to the trial.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
5/35 • Number of events 15 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Endocrine disorders
Hypothyroidism
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
37.1%
13/35 • Number of events 22 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Ascites
|
8.6%
3/35 • Number of events 4 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Constipation
|
34.3%
12/35 • Number of events 17 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
31.4%
11/35 • Number of events 18 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
14.3%
5/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Mucositis Oral
|
14.3%
5/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
14/35 • Number of events 31 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
10/35 • Number of events 18 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Chills
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Edema Limbs
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Fatigue
|
60.0%
21/35 • Number of events 38 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Fever
|
20.0%
7/35 • Number of events 9 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Malaise
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
5.7%
2/35 • Number of events 4 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
General disorders
Pain
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Abdominal Infection
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Kidney Infection
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Lung Infection
|
8.6%
3/35 • Number of events 5 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Sepsis
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
22.9%
8/35 • Number of events 9 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Infections and infestations
Wound Infection
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
14.3%
5/35 • Number of events 7 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
11.4%
4/35 • Number of events 7 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
LDH Increased
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Raised Alkaline Phosphatase
|
22.9%
8/35 • Number of events 9 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Raised Bilirubin Levels
|
14.3%
5/35 • Number of events 14 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Raised C-Reactive Protein
|
11.4%
4/35 • Number of events 8 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Raised Creatinine
|
11.4%
4/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Investigations
Weight Loss
|
22.9%
8/35 • Number of events 9 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.7%
16/35 • Number of events 23 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.6%
3/35 • Number of events 5 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.6%
3/35 • Number of events 4 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
28.6%
10/35 • Number of events 14 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 4 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Psychiatric disorders
Confusion
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.7%
2/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Renal and urinary disorders
Urinary Frequency
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.7%
2/35 • Number of events 6 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
4/35 • Number of events 4 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.7%
9/35 • Number of events 10 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
11.4%
4/35 • Number of events 7 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
17.1%
6/35 • Number of events 7 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.4%
4/35 • Number of events 5 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
8.6%
3/35 • Number of events 3 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
8.6%
3/35 • Number of events 4 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
|
Vascular disorders
Thromboembolic Event
|
5.7%
2/35 • Number of events 2 • From the date of trial consent until 6 months after treatment discontinuation. If at the 6 month review time-point, any toxicities at grade 2 or higher related to trial treatment were still occurring, these were to be followed up until resolution or grade reduction to grade 1, for a minimum of 18 months post-registration, if trial treatment was discontinued early, or up to 24 months post-registration for those completing trial treatment.
|
Additional Information
ANICCA-Class II Trial Coordinator
Cancer Research UK Clinical Trials Unit, University of Birmingham
Phone: 0121 414 8040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place