Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma

  • End date
    May 1, 2024
  • participants needed
  • sponsor
    University of Washington
Updated on 7 July 2022
monoclonal antibodies
systemic therapy
direct bilirubin
neutrophil count
liver metastasis
autoimmune disease
anticoagulation therapy
advanced urothelial carcinoma


This phase II trial studies how well neutron radiation therapy and pembrolizumab work in treating participants with urothelial carcinoma that has spread to other places in the body. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy and pembrolizumab may work better than radiation alone in treating participants with urothelial carcinoma that has spread to other places in the body.



Participants receive pembrolizumab intravenously (IV) on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 3 months.

Condition Urothelial Carcinoma
Treatment radiation therapy, laboratory biomarker analysis, Pembrolizumab
Clinical Study IdentifierNCT03486197
SponsorUniversity of Washington
Last Modified on7 July 2022


Yes No Not Sure

Inclusion Criteria

Pathologically proven (either histologic or cytologic) diagnosis of urothelial carcinoma
At least two sites of disease that are measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Eligible for checkpoint inhibitor immunotherapy (pembrolizumab) per standard of care
No history of autoimmune disease requiring systemic therapy (e.g. steroids or biologic agents)
Absolute neutrophil count (ANC) ≥ 1500 /mcL
Platelets ≥ 100,000/mcL
Hemoglobin > 9 g/dL
Creatinine ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL/min
Total bilirubin ≤ 1.5 ULN OR direct bilirubin ≤ ULN if total bilirubin > 1.5 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN OR < 5 x ULN if patient has liver metastasis
Albumin >= 2.5 g/dL
International normalized ratio (INR) or PT ≤ 1.5 x ULN unless on anticoagulation therapy, in which case prothrombin time (PT) or partial thromboplastin time (PTT) should be in the therapeutic range
PTT ≤ 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range
Eligible for neutron radiation treatment to 1-3 sites of metastatic disease (lesions do not have to be symptomatic)
No steroids for at least 2 weeks prior to enrollment, and patient must not be expected to require steroids during the study period
Zubrod performance status 0-2
Patient must sign study specific informed consent prior to study entry
Patients who are sexually active must use medically acceptable forms of contraception
Life expectancy must be > 3 months

Exclusion Criteria

Has a known history of active TB (Bacillus tuberculosis)
Hypersensitivity to pembrolizumab or any of its excipients
Has a known additional malignancy that is progressing or requires active treatment
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known history of, or any evidence of active, non-infectious pneumonitis
Has an active infection requiring systemic therapy
Has received a live vaccine within 30 days of planned start of study therapy
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided there is no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
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