Trial Outcomes & Findings for Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma (NCT NCT04856189)

Last Updated: 2026-01-29

Results Overview

Defined by dose-limiting toxicity (DLTs). Dose limiting toxicities will be listed according to dose level. Separately by dose level and the expansion cohort (as well as for the total RP2D cohort), adverse events (AEs) will be summarized as number of patients according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 term and grade, where grade is the maximum across a patient's treatment period.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to 2 cycles (each cycle is 21 days); up to about 6 weeks

Results posted on

2026-01-29

Participant Flow

Study was terminated prior to patients being enrolled at the second dose level.

Participant milestones

Participant milestones
Measure	Treatment (Selinexor, Pembrolizumab) Patients received study intervention at Dose Level 1 (starting dose): selinexor 80mg PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV. Selinexor: Given PO. No patients enrolled at other dose levels,
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Selinexor and Pembrolizumab for the Treatment of Cisplatin-Ineligible or Cisplatin-Refractory Locally Advanced or Metastatic Urothelial Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Selinexor, Pembrolizumab) n=4 Participants Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV. Selinexor: Given PO
Age, Categorical <=18 years	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=35 Participants
Age, Categorical >=65 years	3 Participants n=35 Participants
Sex: Female, Male Female	1 Participants n=35 Participants
Sex: Female, Male Male	3 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants
Region of Enrollment United States	4 participants n=35 Participants

PRIMARY outcome

Timeframe: Up to 2 cycles (each cycle is 21 days); up to about 6 weeks

Population: 3 patients treated at dose level 1 were evaluable before study was terminated.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Pembrolizumab) n=3 Participants Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: 200 mg, given IV Selinexor: 80 mg, given PO
Recommended Phase 2 Dose (RP2D) (Phase Ib)	NA mg Selinexor Study was terminated prematurely, and insufficient number of patients were enrolled to assess this outcome measure.

PRIMARY outcome

Timeframe: Up to approximately 2 years 4 months

ORR, calculated as the total number of patients with a confirmed complete response or partial response, will be reported as a percentage of total evaluable patients. Response will be reported using Response Evaluation Criteria in Solid Tumor 1.1 definitions. ORR will be summarized by exact binomial 95% confidence intervals (CI).

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Pembrolizumab) n=4 Participants Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: 200 mg, given IV Selinexor: 80 mg, given PO
Objective Response Rate (ORR) (Phase II)	75 percentage of patients

SECONDARY outcome

Timeframe: Up to approximately 1 year 7 months.

Population: 4 patients were enrolled, after which study was terminated; 4 patients were evaluable for safety.

Defined by NCI CTCAE version 5. The number of patients who experience at least one grade 3-5 AEs will be reported.

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Pembrolizumab) n=4 Participants Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: 200 mg, given IV Selinexor: 80 mg, given PO
Number of Patients Who Experience a Grade 3 or Higher Adverse Event (AE).	1 Participants

SECONDARY outcome

Timeframe: From enrollment to trial to time of disease progression or death from any cause, assessed up to 2 year 4 months.

Progression-free survival (PFS) defined as the median time from initiation of study intervention to progressive disease, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

Outcome measures

Outcome measures
Measure	Treatment (Selinexor, Pembrolizumab) n=4 Participants Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: 200 mg, given IV Selinexor: 80 mg, given PO
Progression-free Survival (PFS)	NA months Interval 0.0 to Median PFS not determined because PFS was not reached by any patient (0 to not reached) at the time of data cut-off due to the study being prematurely terminated.

Adverse Events

Treatment (Selinexor, Pembrolizumab)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Selinexor, Pembrolizumab) n=4 participants at risk Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV. Selinexor: Given PO
Infections and infestations Sepsis	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Infections and infestations Lung infection	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.

Other adverse events

Other adverse events
Measure	Treatment (Selinexor, Pembrolizumab) n=4 participants at risk Patients receive selinexor PO on days 1, 8 and 15, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV. Selinexor: Given PO
Gastrointestinal disorders Abdominal pain	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Blood and lymphatic system disorders Anemia	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Anorexia	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Musculoskeletal and connective tissue disorders Back pain	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Blood bicarbonate decreased	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Eye disorders Blurred vision	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Eye disorders Cataract	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Chills	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Gastrointestinal disorders Constipation	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Creatinine increased	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Psychiatric disorders Delirium	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Gastrointestinal disorders Diarrhea	100.0% 4/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Nervous system disorders Dizziness	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Eye disorders Dry eye	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Nervous system disorders Dysgeusia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Ear and labyrinth disorders Fullness in ears	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Edema face	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Eye disorders Gritty eyes	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Eye disorders Eye pain	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Fatigue	100.0% 4/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Fever	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Eye disorders Floaters	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Generalized edema	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Nervous system disorders Headache	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Ear and labyrinth disorders Hearing impaired	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hyperglycemia	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Vascular disorders Hypertension	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hypokalemia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hyponatremia	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Infections and infestations COVID 19	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Infections and infestations Flu	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Psychiatric disorders Insomnia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Lymphocyte count decreased	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Malaise	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Gastrointestinal disorders Nausea	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
General disorders Neck edema	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Neutrophil count decreased	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Gastrointestinal disorders Non-cardiac chest pain	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Platelet count decreased	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Productive cough	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Renal and urinary disorders Proteinuria	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Skin and subcutaneous tissue disorders Rash acneiform	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other: Hallux great toe	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other: Rosacea	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other: Lip lesion (discoloration)	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Renal and urinary disorders Urinary frequency	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Renal and urinary disorders Urinary retention	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Renal and urinary disorders Urinary tract infection	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Renal and urinary disorders Urinary urgency	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Gastrointestinal disorders Vomiting	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations Weight loss	50.0% 2/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Respiratory, thoracic and mediastinal disorders Wheezing	25.0% 1/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.
Investigations White blood cell decreased	75.0% 3/4 • Adverse events and serious adverse events assessed from first dose to 30 days after last treatment, approximately up to 1 year 7 months. All-cause mortality assessed from enrollment until death from any cause, approximately 2 years 4 months.

Additional Information

Leslie Garcia

University of California, Davis

Phone: 916-734-0156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place