Trial Outcomes & Findings for A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC) (NCT NCT04907539)
NCT ID: NCT04907539
Last Updated: 2025-04-16
Results Overview
The anti-tumour activity of RXC004 monotherapy was evaluated. DCR is defined as the percentage of patients with a BOR of either complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks post baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 28 months
Results posted on
2025-04-16
Participant Flow
This study was conducted from 08 November 2021 to 02 April 2024 at multiple centers in 4 countries (South Korea, Spain, United Kingdom and United States of America).
Patients who met the inclusion criteria, and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the Schedule of Assessment.
Participant milestones
| Measure |
Arm A: RXC004 Monotherapy
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
8
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
15
|
3
|
Reasons for withdrawal
| Measure |
Arm A: RXC004 Monotherapy
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Overall Study
Consent withdrawn
|
1
|
0
|
|
Overall Study
Death
|
14
|
3
|
Baseline Characteristics
A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC)
Baseline characteristics by cohort
| Measure |
Arm A: RXC004 Monotherapy
n=17 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 Year
STANDARD_DEVIATION 13.87 • n=39 Participants
|
64.8 Year
STANDARD_DEVIATION 7.78 • n=41 Participants
|
57.0 Year
STANDARD_DEVIATION 13.24 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
14 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 28 monthsPopulation: Evaluable set consisted of all patients who received radiographic assessment at baseline (with measurable disease according to RECIST 1.1), received at least 4 weeks of study treatment and at least 1 post-dose radiographic tumour assessment or progressed or died ahead of the first radiographic assessment. Patients with important protocol deviations that may have impacted outcome were excluded from the population.
The anti-tumour activity of RXC004 monotherapy was evaluated. DCR is defined as the percentage of patients with a BOR of either complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks post baseline.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=11 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
RXC004 Monotherapy (Arm A): Disease Control Rate (DCR) Using Each Patient's Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1)
|
18.2 Percentage of patients
Interval 3.33 to 47.01
|
—
|
PRIMARY outcome
Timeframe: Up to 28 monthsPopulation: Evaluable set consisted of all patients who received radiographic assessment at baseline (with measurable disease according to RECIST 1.1), received at least 4 weeks of study treatment and at least 1 post-dose radiographic tumour assessment or progressed or died ahead of the first radiographic assessment. Patients with important protocol deviations that may have impacted outcome were excluded from the population.
The anti-tumour activity as a combination therapy of RXC004 +nivolumab was evaluated. ORR is defined as the percentage of patients with a BOR of CR or PR based on local investigator assessment, as defined in RECIST 1.1.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=7 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
RXC004+Nivolumab Combination Therapy (Arm B): Objective Response Rate (ORR) Using Each Patient's BOR According to RECIST 1.1
|
14.3 Percentage of patients
Interval 0.73 to 52.07
|
—
|
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Evaluable set consisted of all patients who received radiographic assessment at baseline (with measurable disease according to RECIST 1.1), received at least 4 weeks of study treatment and at least 1 post-dose radiographic tumour assessment or progressed or died ahead of the first radiographic assessment. Patients with important protocol deviations that may have impacted outcome were excluded from the population.
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. The best percentage change in tumour size was determined at a patient level. Percentage change in tumour size was derived at each visit by the percentage change from baseline in the sum of diameters of target lesions. The best percentage change in tumour size was the patients value representing the largest decrease (or smallest increase) from baseline in tumour size.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=11 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=7 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Best Percentage Change in Tumor Size
|
9.34 Percentage change in tumor size
Interval -11.8 to 59.8
|
0.00 Percentage change in tumor size
Interval -40.4 to 39.4
|
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Full analysis set consisted of all patients who were enrolled and received at least one dose of study drug (RXC004).
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. PFS is defined as the time from first dose of study treatment until the date of disease progression or death (by any cause in the absence of progression).
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=17 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.0 Months
Interval 1.31 to 2.33
|
3.9 Months
Interval 1.58 to
Due to insufficient number of patients with events, estimates were not calculable using methodology specified in Statistical Analysis Plan (SAP).
|
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Evaluable set consisted of all patients who received radiographic assessment at baseline (with measurable disease according to RECIST 1.1) received at least 4 weeks of treatment and at least 1 post-dose radiographic tumour assessment or progressed or died ahead of the first radiographic assessment. Patients with important protocol deviations that may impact outcome were excluded from population.
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. The DOR is as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. DOR was not calculated as 1 patient had PR, and 0 patient had CR. As pre-specified in the SAP that after the review of the available data, DOR would not be summarized and listed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Evaluable set consisted of all patients who received radiographic assessment at baseline (with measurable disease according to RECIST 1.1), received at least 4 weeks of study treatment and at least 1 post-dose radiographic tumour assessment or progressed or died ahead of the first radiographic assessment. Patients with important protocol deviations that may impact outcome were excluded from the population.
The preliminary efficacy of RXC004 monotherapy was evaluated. ORR is defined as the percentage of patients with a BOR of CR or PR based on local investigator assessment as defined in RECIST 1.1.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=11 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
RXC004 Monotherapy (Arm A): Objective Response Rate (ORR) Using Investigator Assessments According to RECIST 1.1
|
0 Percentage of patients
Interval 0.0 to 23.84
|
—
|
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Evaluable set consisted of all patients who received radiographic assessment at baseline (with measurable disease according to RECIST 1.1), received at least 4 weeks of study treatment and at least 1 post-dose radiographic tumour assessment or progressed or died ahead of the first radiographic assessment. Patients with important protocol deviations that may impact outcome were excluded from the population.
The preliminary efficacy of combination therapy of RXC004 + nivolumab was evaluated. DCR is defined as the percentage of patients with a BOR of either CR, PR or SD for at least 16 weeks post baseline.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=7 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
RXC004 + Nivolumab Combination Therapy (Arm B): Disease Control Rate Using Investigator Assessments According to RECIST 1.1
|
57.1 Percentage of patients
Interval 22.53 to 87.12
|
—
|
SECONDARY outcome
Timeframe: Up to 28 monthsPopulation: Full analysis set consisted of all patients who were enrolled and received at least one dose of study drug (RXC004).
The preliminary efficacy of RXC004 monotherapy and combination therapy of RXC004 + nivolumab was evaluated. OS is defined as the time from first day of study treatment until death due to any cause.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=17 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Overall Survival (OS)
|
4.8 Months
Interval 1.3 to 6.5
|
NA Months
Interval 1.7 to
Due to insufficient follow-up information, the median for Arm B was not reached and the estimates were not calculable as per methodology specified in SAP.
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length) and Cycle 1 Day 15 (28 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The pharmacokinetic (PK) (Cmax) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=17 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Cycle 0 Day 1
|
65.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 62.0
|
56.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56.4
|
|
Maximum Observed Plasma Concentration (Cmax)
Cycle 1 Day 15
|
80.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 66.8
|
79.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42.7
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length) and Cycle 1 Day 15 (28 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (Tmax) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=17 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
Cycle 0 Day 1
|
2.07 Hour (h)
Interval 0.983 to 4.18
|
1.95 Hour (h)
Interval 0.933 to 2.12
|
|
Time to Maximum Plasma Concentration (Tmax)
Cycle 1 Day 15
|
1.35 Hour (h)
Interval 0.517 to 6.12
|
1.98 Hour (h)
Interval 1.02 to 10.4
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 15 (28 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (Cmin) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=11 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=7 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Minimum Observed Concentration Across the Dosing Interval (Cmin)
|
12.8 ng/mL
Geometric Coefficient of Variation 65.8
|
17.2 ng/mL
Geometric Coefficient of Variation 49.4
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (λz) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=11 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Terminal Rate Constant (λz)
|
0.0769 1/hour
Geometric Coefficient of Variation 73.3
|
0.0540 1/hour
Geometric Coefficient of Variation 29.8
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (t½) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=11 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=7 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Terminal Half-life (t½)
|
9.02 hour (h)
Geometric Coefficient of Variation 73.3
|
12.2 hour (h)
Geometric Coefficient of Variation 27.7
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (AUC0-∞) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=10 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=6 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-∞)
|
733 hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 48.9
|
749 hour*nanogram/milliliter (h*ng/mL)
Geometric Coefficient of Variation 45.0
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (CL/F) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=10 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=6 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Total Plasma Clearance After Oral Administration (CL/F)
|
2730 milliliter per hour (mL/h)
Geometric Coefficient of Variation 48.9
|
2000 milliliter per hour (mL/h)
Geometric Coefficient of Variation 45.0
|
SECONDARY outcome
Timeframe: On Cycle 0 Day 1 (3-7 days cycle in length)Population: The PK Analysis Set included all patients in the full analysis set with at least 1 blood sample.
The PK (Vz/F) of RXC004 in monotherapy and in combination therapy with nivolumab was evaluated.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=10 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=6 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Apparent Volume of Distribution After Oral Administration (Vz/F)
|
32300 milliliter (mL)
Geometric Coefficient of Variation 89.6
|
35800 milliliter (mL)
Geometric Coefficient of Variation 22.0
|
SECONDARY outcome
Timeframe: From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)Population: The safety analysis set consisted of all patients who were enrolled and received at least one dose of study drug (RXC004).
The safety and tolerability profile of RXC004 monotherapy and RXC004 + nivolumab combination was evaluated. The grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse events (CTCAE) latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.
Outcome measures
| Measure |
Arm A: RXC004 Monotherapy
n=17 Participants
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 Participants
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Number of Patients With Adverse Events (AEs)
Nivolumab Related Serious TEAE
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Death
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Reduction of RXC004
|
3 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Permanent Discontinuation or Interruption of Nivolumab
|
0 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events (AEs)
RXC004 Related TEAE
|
14 Participants
|
8 Participants
|
|
Number of Patients With Adverse Events (AEs)
Nivolumab Related TEAE
|
1 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events (AEs)
RXC004 Related Grade >=3 TEAE
|
3 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events (AEs)
RXC004 Related Serious TEAE
|
2 Participants
|
4 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Permanent Discontinuation or Reduction or Interruption of RXC004
|
10 Participants
|
7 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Permanent Discontinuation of RXC004
|
2 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Interruption of RXC004
|
8 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Permanent Discontinuation of Nivolumab
|
0 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events (AEs)
TEAE Leading to Interruption of Nivolumab
|
0 Participants
|
3 Participants
|
|
Number of Patients With Adverse Events (AEs)
Treatment emergent adverse event (TEAE)
|
17 Participants
|
8 Participants
|
|
Number of Patients With Adverse Events (AEs)
Grade >=3 TEAE
|
9 Participants
|
5 Participants
|
|
Number of Patients With Adverse Events (AEs)
Nivolumab Related Grade >=3 TEAE
|
0 Participants
|
2 Participants
|
|
Number of Patients With Adverse Events (AEs)
Serious TEAE
|
3 Participants
|
5 Participants
|
Adverse Events
Arm A: RXC004 Monotherapy
Serious events: 3 serious events
Other events: 17 other events
Deaths: 14 deaths
Arm B: RXC004+Nivolumab
Serious events: 5 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A: RXC004 Monotherapy
n=17 participants at risk
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 participants at risk
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Enteritis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
General disorders
Death
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
Other adverse events
| Measure |
Arm A: RXC004 Monotherapy
n=17 participants at risk
Patients received 2 mg of RXC004 monotherapy once daily orally.
|
Arm B: RXC004+Nivolumab
n=8 participants at risk
Patients received 1.5 mg of RXC004 once daily along with the combination of 480 mg of Nivolumab every 4 weeks orally.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.5%
4/17 • Number of events 5 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Cardiac disorders
Bundle branch block right
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Eye disorders
Eye pain
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • Number of events 15 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
50.0%
4/8 • Number of events 8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
4/17 • Number of events 6 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
62.5%
5/8 • Number of events 7 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
4/17 • Number of events 10 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
37.5%
3/8 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
3/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
General disorders
Fatigue
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
50.0%
4/8 • Number of events 5 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
General disorders
Asthenia
|
23.5%
4/17 • Number of events 4 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
General disorders
Influenza like illness
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
General disorders
Chills
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
General disorders
Pyrexia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Hepatobiliary disorders
Jaundice
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Lower respiratory tract infection
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
COVID-19
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Folliculitis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Infections and infestations
Tonsillitis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Injury, poisoning and procedural complications
Stoma prolapse
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Weight decreased
|
11.8%
2/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
50.0%
4/8 • Number of events 4 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Blood bilirubin increased
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
37.5%
3/8 • Number of events 5 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Amylase increased
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
C-reactive protein increased
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Carcinoembryonic antigen increased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Gastric pH decreased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Lipase increased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Protein urine present
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Urine calcium decreased
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Investigations
Vitamin D decreased
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
47.1%
8/17 • Number of events 10 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
62.5%
5/8 • Number of events 6 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.6%
3/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.8%
2/17 • Number of events 4 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
37.5%
3/8 • Number of events 4 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.6%
3/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Dysgeusia
|
52.9%
9/17 • Number of events 11 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
75.0%
6/8 • Number of events 7 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Lethargy
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Ageusia
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Loss of consciousness
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Seizure
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Psychiatric disorders
Mental status changes
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
37.5%
3/8 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
50.0%
4/8 • Number of events 4 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
37.5%
3/8 • Number of events 4 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
11.8%
2/17 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
25.0%
2/8 • Number of events 2 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/17 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
12.5%
1/8 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 3 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
|
Vascular disorders
Thrombosis
|
5.9%
1/17 • Number of events 1 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
0.00%
0/8 • From time of signature of informed consent form throughout the treatment period and until 30 days after the last dose of RXC004 (for RXC004 monotherapy only) or 90 days after the last dose of Nivolumab (for RXC004 + nivolumab) (up to 28 months)
Safety Set included all patients who were enrolled and received at least one dose of study drug (RXC004).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place