Trial Outcomes & Findings for Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo (NCT NCT03421652)

Last Updated: 2023-08-04

Results Overview

PFS distribution will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for PFS will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (12-month PFS rate, median PFS, etc.) will be calculated from the K-M life table, each one with its respective 90% confidence interval (CI).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From date of registration to date of first documented disease relapse/progression, or death from urothelial cancer whichever occurs first, assessed up to 12 months

Results posted on

2023-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Nivolumab, Radiation Therapy) Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 Participants Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Age, Continuous	78.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Performance Status 0	3 Participants n=5 Participants
Performance Status 1	16 Participants n=5 Participants
Performance Status 2	1 Participants n=5 Participants
Pathological stage T2Nx: Clinically main tumor invades muscularis propria, Cancer in lymph nodes cannot be measured.	6 Participants n=5 Participants
Pathological stage pT2: Pathologically invades muscularis propria	3 Participants n=5 Participants
Pathological stage pT2N1: Pathologically invades muscularis propria with a single node in the true pelvis	1 Participants n=5 Participants
Pathological stage pT2Nx: Pathologically tumor invades muscularis propria, Cancer in lymph nodes not measurable.	6 Participants n=5 Participants
Pathological stage pT2b: Pathologically invades the outer half of the muscularis propria.	2 Participants n=5 Participants
Pathological stage pT4: Pathologically directly invades into adjacent structures.	2 Participants n=5 Participants
Prior Bacillus Calmette-Guerin (BCG) Therapy No	15 Participants n=5 Participants
Prior Bacillus Calmette-Guerin (BCG) Therapy Yes	5 Participants n=5 Participants
Prior Chemotherapy No	17 Participants n=5 Participants
Prior Chemotherapy Yes	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of registration to date of first documented disease relapse/progression, or death from urothelial cancer whichever occurs first, assessed up to 12 months

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 Participants Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Progression-free Survival (PFS)	11.4 months Interval 7.5 to 23.7

SECONDARY outcome

Timeframe: Up to 12 months

ORR will be estimated among all patients. Frequency distributions of best response will be generated. The point estimate of the ORR will be computed, along with its 95% (Wilson type) CI.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 Participants Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Overall Response Rate (ORR)	65.0 percentage of response at 12 months Interval 43.3 to 81.8

SECONDARY outcome

Timeframe: From registration to the appearance of metastases or cancer related death, assessed up to 12 months

MFS will be calculated as a rate at 1 year with a 90% confidence interval from the K-M life tables.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 Participants Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Metastasis-free Survival (MFS)	63 % of patients metastases-free at 1 year Interval 41.0 to 84.0

SECONDARY outcome

Timeframe: From date of registration to death or last follow up, assessed up to 36 months

Summary statistics of OS will be calculated from the K-M life tables. K-M graphs of the censored OS distributions will also be generated.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 Participants Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Overall Survival (OS)	15.6 months Interval 9.1 to 26.1

SECONDARY outcome

Timeframe: Up to 12 months

Population: Measure not taken

The QOL score will be measured pre therapy, during therapy and after therapy to compare the changes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Those patients that had pre-therapy tumor tissue analyzed for PD-1 and PD-L1 (18 participants total).

PD-1 status will be checked on pre-therapy tumor tissue and will be correlated with the primary endpoint. Also, the PDL-1 status will be checked on pre-therapy tumor tissue and will be correlated with the primary endpoint.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab, Radiation Therapy) n=18 Participants Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
PD-1 and PDL-1 Expression Analysis Using Immunohistochemistry (IHC) PD-1 <5	44 % of patients progression-free at 1 year Interval 16.0 to 73.0
PD-1 and PDL-1 Expression Analysis Using Immunohistochemistry (IHC) PD-1 =>5	35 % of patients progression-free at 1 year Interval 0.0 to 80.0
PD-1 and PDL-1 Expression Analysis Using Immunohistochemistry (IHC) PD-L1 <5	36 % of patients progression-free at 1 year Interval 11.0 to 62.0
PD-1 and PDL-1 Expression Analysis Using Immunohistochemistry (IHC) PD-L1 =>5	55 % of patients progression-free at 1 year Interval 14.0 to 95.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Measure not taken

The continuous markers (e.g., tumor infiltrating lymphocyte \[TIL\]s, Th1/Th2 cytokine ratio, etc.) will be summarized with standard descriptive statistics. These descriptive analyses of the serum markers will be performed for each time point at which the each marker is determined. Response (CR/PR vs not) will be modeled as a function of a dichotomized version of pre-study the continuous (ungrouped) markers (e.g., TILs from tissue, and the Th1/Th2 cytokine ratio from serum). The statistical goal of these exploratory analyses is to obtain the point and 95% CI estimates of the OR, and to simply determine the direction and approximate magnitude of these associations for use in planning a subsequent study. Censored PFS will be modeled as a function of a dichotomized version of the continuous (ungrouped) markers (e.g., TILs from tissue, and the Th1/Th2 cytokine ratio using Cox modelling strategy.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Nivolumab, Radiation Therapy)

Serious events: 11 serious events

Other events: 19 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 participants at risk Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
General disorders General disorders and administration site conditions - Other, specify	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Hyponatremia	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Lymphocyte count decreased	20.0% 4/20 • Number of events 9 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Blood and lymphatic system disorders Anemia	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Infections and infestations Bladder infection	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Dehydration	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Injury, poisoning and procedural complications Fall	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Fatigue	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Injury, poisoning and procedural complications Fracture	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Myalgia	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Myositis	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Reproductive system and breast disorders Pelvic pain	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Skin and subcutaneous tissue disorders Rash maculo-papular	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Renal and urinary disorders - Other, specify	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Nervous system disorders Stroke	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Infections and infestations Urinary tract infection	15.0% 3/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Localized edema	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Cystitis noninfective	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Soft tissue necrosis lower limb	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months

Other adverse events

Other adverse events
Measure	Treatment (Nivolumab, Radiation Therapy) n=20 participants at risk Given IV Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9. Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Alanine aminotransferase increased	10.0% 2/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Immune system disorders Allergic reaction	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Skin and subcutaneous tissue disorders Alopecia	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Blood and lymphatic system disorders Anemia	20.0% 4/20 • Number of events 7 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Anorexia	30.0% 6/20 • Number of events 8 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Psychiatric disorders Anxiety	15.0% 3/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Eye disorders Blurred vision	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Injury, poisoning and procedural complications Bruising	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Chest wall pain	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Chills	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Psychiatric disorders Confusion	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Constipation	25.0% 5/20 • Number of events 7 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Respiratory, thoracic and mediastinal disorders Cough	15.0% 3/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Creatinine increased	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Dehydration	20.0% 4/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Psychiatric disorders Depression	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Diarrhea	60.0% 12/20 • Number of events 19 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Dry mouth	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Nervous system disorders Dysgeusia	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	15.0% 3/20 • Number of events 5 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Eye disorders Eye disorders - Other, specify	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Fatigue	75.0% 15/20 • Number of events 18 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Fecal incontinence	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Hematuria	15.0% 3/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Endocrine disorders Hyperthyroidism	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Hypoalbuminemia	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Hypocalcemia	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Hypokalemia	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Metabolism and nutrition disorders Hyponatremia	15.0% 3/20 • Number of events 6 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Endocrine disorders Hypothyroidism	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Infections and infestations Infections and infestations - Other, specify	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Psychiatric disorders Insomnia	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Psychiatric disorders Libido decreased	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Lymphocyte count decreased	20.0% 4/20 • Number of events 16 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Nervous system disorders Memory impairment	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Myalgia	10.0% 2/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Musculoskeletal and connective tissue disorders Myositis	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Neutrophil count decreased	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Pain	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Reproductive system and breast disorders Pelvic pain	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Nervous system disorders Peripheral sensory neuropathy	10.0% 2/20 • Number of events 3 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Platelet count decreased	15.0% 3/20 • Number of events 5 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 2/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Renal and urinary disorders - Other, specify	15.0% 3/20 • Number of events 5 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Infections and infestations Sinusitis	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Vascular disorders Thromboembolic event	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Urinary frequency	25.0% 5/20 • Number of events 5 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Urinary incontinence	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Infections and infestations Urinary tract infection	35.0% 7/20 • Number of events 8 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Reproductive system and breast disorders Vaginal pain	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Vomiting	15.0% 3/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Weight loss	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Bladder spasm	5.0% 1/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations White blood cell decreased	20.0% 4/20 • Number of events 4 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Edema limbs	30.0% 6/20 • Number of events 7 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
General disorders Infusion related reaction	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Investigations Urine output decreased	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Infections and infestations Lung infection	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Reproductive system and breast disorders Erectile dysfunction	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Urinary tract pain	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Renal and urinary disorders Cystitis noninfective	10.0% 2/20 • Number of events 2 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months
Gastrointestinal disorders Gastroesophageal reflux disease	5.0% 1/20 • Number of events 1 • All-cause mortality was assessed up to 36 months, and serious and Other (Not Including Serious) Adverse Events were assessed for up to 6 months

Additional Information

Nitin Vaishampayan, MD

Karmanos Cancer Institute

Phone: 313-576-9624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place