Trial Outcomes & Findings for Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer (NCT NCT02662062)

NCT ID: NCT02662062

Last Updated: 2025-01-27

Results Overview

Unacceptable toxicity was predefined as fitting one of the following categories. * Grade 3 or worse adverse event per CTCAE V 5.0 (excluding urinary adverse events Grade 3 and Grade 4) * Cisplatin is withheld for 2 or more doses * Cisplatin is withheld or dose reduced such that \<66% of the intended total cisplatin dose is delivered * Radiation therapy extended beyond 7 weeks * Any single pembrolizumab dose is delayed for \>6 weeks

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

12 weeks of study treatment

Results posted on

2025-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Overall Study STARTED	28
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=28 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Age, Continuous	72 years n=28 Participants
Sex: Female, Male Female	2 Participants n=28 Participants
Sex: Female, Male Male	26 Participants n=28 Participants
Region of Enrollment Australia	28 participants n=28 Participants
ECOG ECOG 0	18 Participants n=28 Participants
ECOG ECOG 1	10 Participants n=28 Participants
Histology Transitional cell/ Urothelial	25 Participants n=28 Participants
Histology Mixed Transitional/ nontransitional	3 Participants n=28 Participants
Histology Associated carcinoma in situ	9 Participants n=28 Participants
T stage T2	26 Participants n=28 Participants
T stage T3	2 Participants n=28 Participants
Prior BCG (Bacillis Calmette-Guerin vaccine) treatment	2 Participants n=28 Participants

PRIMARY outcome

Timeframe: 12 weeks of study treatment

Outcome measures

Outcome measures
Measure	Pembrolizumab n=28 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined Below Unacceptable toxicity - total	9 Participants
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined Below Grade 3 or higher adverse event	6 Participants
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined Below Immune mediated toxicity meeting unacceptable toxicity definition.	2 Participants
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined Below Cisplatin dose omissions 2 or greater	4 Participants
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined Below Radiation duration >7 weeks	2 Participants
The Number of Participants Experiencing an Unacceptable Level of Toxicity as Defined Below Pembrolizumab >6 weeks delay	1 Participants

SECONDARY outcome

Timeframe: Week 19 (12 weeks post chemotherapy)

Population: Only 21 patients were evaluable at this timepoint

Complete response defined at this time point by fulfillment of all of the following criteria: i) the bi-manual examination under anesthesia is negative (performed at the time of cystoscopy) ii) All biopsies are negative for any tumor at the site(s) of pre-treatment tumor(s) iii) There is an absence of metastatic disease on most recently performed imaging of chest/abdomen and pelvis

Outcome measures

Outcome measures
Measure	Pembrolizumab n=21 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Complete Response Rate at Week 19 of the Trial (12 Weeks Post Completion of Chemoradiotherapy).	90 Percentage of evaluable population Interval 70.0 to 99.0

SECONDARY outcome

Timeframe: Week 31 of the trial (24 weeks post completion of chemoradiotherapy)

Population: two participants not evaluable for this endpoint due to withdrawal of consent (1) and death from an exacerbation of pre-existing airways disease (1)

Outcome measures

Outcome measures
Measure	Pembrolizumab n=26 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
The Complete Response Rate Assessed at Week 31 of the Trial (24 Weeks Post Completion of Chemoradiotherapy).	88 Percentage of evaluable population Interval 70.0 to 98.0

SECONDARY outcome

Timeframe: median follow up 39 months

Population: 2 participants not evaluable for this endpoint due to withdrawal of consent (1) and death from pre-existing airways disease (1)

Estimation after characterization with a Kaplan Meier curve

Outcome measures

Outcome measures
Measure	Pembrolizumab n=26 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Estimated Median Overall Survival	39 months Interval 17.0 to missing upper level of 95% confidence interval on the survival estimate from Kaplan-Meier estimator due to small number of events

SECONDARY outcome

Timeframe: 12 months post study entry

Population: Two participants not evaluable for this endpoint due to withdrawal of consent (1) and death from pre-existing airways disease (1)

Overall survival timepoint estimated after characterization on a Kaplan Meier curve

Outcome measures

Outcome measures
Measure	Pembrolizumab n=26 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Overall Survival at 12 Months Post Study Entry	92 Percentage of evaluable population Interval 72.0 to 98.0

SECONDARY outcome

Timeframe: At 12 months post study entry

Population: 1 patient was not evaluable for this time point due to withdrawal of consent 1 patient was not evaluable for this time point due to death related to pre-existing chronic airways disease

End point was characterized using a Kaplan Meier curve and 12 month time point assessed.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=26 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Distant Metastasis Free Survival (DMFS) at 12 Months	85 Percentage of population Interval 64.0 to 94.0

SECONDARY outcome

Timeframe: 12 months post therapy commencement

Population: Two participants not evaluable for this outcome measure for reasons of withdrawal of consent (1) and death from pre-existing airways disease (1)

Local recurrence was defined as recurrence in the bladder or a nodal recurrence in the pelvis

Outcome measures

Outcome measures
Measure	Pembrolizumab n=26 Participants Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Local Disease Free Survival (LRPFS) at 12 Months	88 Percentage of evaluable population Interval 68.0 to 98.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 7 years.

Resected tumour specimens will be available from the patients enrolled on the trial. These pre-treatment specimens will be comprehensively profiled for the abundance and composition of tumour infiltrating lymphocytes (CD4, CD8, CD3, CD20 and FoxP3 positive cells) by immunohistochemistry using the state-of-the-art Vectra Automated Imaging system which enables multiplexed immunohistochemical analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 7 years.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 7 years.

Blood samples collected prior to treatment, at the end of chemoradiotherapy, and after 24 weeks will be collected from the patients on the trial. PBMCs will be isolated using Ficoll, and changes in specific immune subpopulations (number/ratio) determined by multi-parameter FACS. Changes in the immune regulatory molecules OX-40/LAG3/PD1/ICOS on T cell subsets will be assessed by flow cytometry.

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab

Serious events: 13 serious events

Other events: 27 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=28 participants at risk Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Infections and infestations Urinary tract infection	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Haematuria	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Fever	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Renal and urinary discorders (other)	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Musculoskeletal and Conncective tissue disorder (other)	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Vascular disorders Hypetension	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Cystitis noninfective	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Product Issues Infusion related reaction	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Metabolism and nutrition disorders Metabolism and nutritional disorder (other)	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Psychiatric disorders Delusions	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Fracture	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Infections and infestations infections and infestations (other)	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Diarrhoea	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Fall	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Cardiac disorders Heart Failure	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Nervous system disorders Nervous system disorders - other	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Endocrine disorders Hypothyroidism	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Acute Kidney Injury	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0

Other adverse events

Other adverse events
Measure	Pembrolizumab n=28 participants at risk Pembrolizumab to be administered via IV 200mg 3 weekly commenced concurrently with chemoradiotherapy, and continuing until 12 week cystoscopy. Pembrolizumab: 200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops. Cisplatin: 35 mg/m2, IV (in the vein) every week for six weeks. Radiotherapy: 2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
Renal and urinary disorders Cystitis Noninfective	21.4% 6/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Haematuria	32.1% 9/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Vascular disorders Hypertension	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Blood and lymphatic system disorders Anaemia	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Blood and lymphatic system disorders Neutrophil count decreased	3.6% 1/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Fatigue	67.9% 19/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Diarrhoea	50.0% 14/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Fever	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Endocrine disorders Hypothyroidism	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Constipation	35.7% 10/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Urinary frequency	57.1% 16/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Chills	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Rash Maculopapular	32.1% 9/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Oedema Limbs	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Blood and lymphatic system disorders Platelet Count Decreased	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Fall	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Urinary Incontinence	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Nausea	21.4% 6/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Alanine Aminotransferase Increased	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Urinary Tract Pain	14.3% 4/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Dry skin	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Gastro-oesophageal reflux disease	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Insomnia	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Nervous system disorders Parasthesia	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Nervous system disorders Tinnitus	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Urinary Urgency	10.7% 3/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Abdominal Pain	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Cough	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Renal and urinary disorders Creatinine increased	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Headache	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Endocrine disorders Hyperthyroidism	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
Gastrointestinal disorders Mucositis Oral	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0
General disorders Weight loss	7.1% 2/28 • Adverse events were collected over the period of enrollment in the study (Planned out to 5 years post commencement) the median follow up at the conclusion of the trial was 39 months Adverse events were collected at each visit during treatment and follow up and they were recorded per CTCAE Version 5.0

Additional Information

Dr Anthony Uccellini - ANZUP Research fellow

ANZUP

Phone: 61 2 9046 8954

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place