Adjuvant Concurrent Immunotherapy and Radiotherapy for the Treatment of Bladder Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pure or mixed variant urothelial carcinoma
squamous differentiation
glandular differentiation
nested pattern
Disqualifiers
Urinary diversion with an orthotopic neobladder
History of inflammatory bowel disease
Prior partial or complete small bowel obstruction either before or after radical cystectomy
Prior radiotherapy to the pelvis;
Trial design
Design model
Single group
Treatments tested in this trial
Concurrent Immunotherapy and Radiation Therapy
RadiationRadiation therapy will begin between 12 to 18 weeks from the start of adjuvant nivolumab. Patients will receive radiation therapy for about 6 weeks.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Concurrent Immunotherapy and Radiation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of concurrent adjuvant immunotherapy and radiation therapy
The primary study endpoint is acute grade 3 or higher pelvic radiation related toxicity. A toxicity will be classified as related to pelvic radiation if the toxicity involves or is the result of effects on tissues that are within the 50% isodose bath of the radiation treatment as defined on the radiation treatment planning simulation scan. Toxicities will be graded by CTCAE Version 5.0. Concurrent adjuvant immunotherapy and radiation will be deemed safe if it is likely (i.e. a posterior probability of 50% or greater) that the acute grade 3 or higher pelvic radiation related toxicity rate is \<20%.
Time frame
Within 18 weeks from start of radiation therapySponsors and contacts
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Source ClinicalTrials.gov