NCT04936230|TerminatedPhase 2ResultsFDA Drug

Study Stopped

Inadequate accrual rate

Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer

Phase II Randomized Trial of Immunotherapy Versus Immunotherapy and Radiation Therapy for Platinum Ineligible/Refractory Metastatic Urothelial Cancer (IMMORTAL)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2021-06326A032002U10CA180821

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2021

StartedNov 2022

CompletionAug 2024

Brief Summary

This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called pembrolizumab versus pembrolizumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). The addition of radiation to immunotherapy may shrink the cancer, but it could also cause side effects. 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. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. The combination of pembrolizumab and radiation therapy may be more efficient in killing tumor cells.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Nov 2022

Geographic Reach

1 country

83 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

June 22, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed

1.4 years until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 17, 2025

Completed

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

June 22, 2021

Results QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Metastatic Urothelial Carcinoma Platinum-Resistant Urothelial Carcinoma Stage IV Bladder Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Tumor Response
Will be defined as a complete response (CR) or partial response (PR) as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Up to 6 months from randomization

Secondary Outcomes (5)

Tumor Response
Up to 3 years from randomization
Progression-free Survival
Time from randomization until disease progression as assessed by the treating physician using RECIST 1.1 or death due to any cause, assessed up to 3 years
Overall Survival
Time from randomization until death due to any cause. Patients who are not known to be dead at time of analysis will be censored at the time of their last follow-up, assessed up to 3 years
Rate of Treatment Discontinuation
At 1 year
Incidence of Adverse Events
Up to 3 years from randomization

Study Arms (2)

Arm A (pembrolizumab)

EXPERIMENTAL

Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan and/or PET scan, as well as optional urine and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: PembrolizumabProcedure: Positron Emission TomographyOther: Questionnaire Administration

Arm B (pembrolizumab, SBRT)

EXPERIMENTAL

Patients receive pembrolizumab as in Arm A. Patients also undergo SBRT QD every other day for 3 fractions over 2 weeks that must be completed before 12 weeks after the first dose of pembrolizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, bone scan, and/or PET scan, as well as optional urine and blood sample collection throughout the study.