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

STATUS

Recruiting
End date

May 1, 2024
participants needed

20
sponsor

University of Washington

Send

Updated on 7 July 2022

See if I qualify

cancer

monoclonal antibodies

systemic therapy

direct bilirubin

metastasis

neutrophil count

liver metastasis

pembrolizumab

autoimmune disease

anticoagulation therapy

advanced urothelial carcinoma

Summary

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.

Description

OUTLINE

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.

Details

Condition	Urothelial Carcinoma
Treatment	radiation therapy, laboratory biomarker analysis, Pembrolizumab
Clinical Study Identifier	NCT03486197
Sponsor	University of Washington
Last Modified on	7 July 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer

monoclonal antibodies

anticoagulation therapy

advanced urothelial carcinoma

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

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