RECRUITING

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial

Talk to us

Conditions

Non-Muscle Invasive Bladder Urothelial CarcinomaRecurrent Non-Muscle Invasive Bladder Urothelial CarcinomaStage I Bladder Cancer AJCC v8

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. 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. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.

Official Title

Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)

Quick Facts

Study Start:2025-12-02
Study Completion:2032-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06770582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)/CT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.
  2. * NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible
  3. * High grade T1 disease history that must meet at least ONE of the three criteria below:
  4. * Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ \[CIS\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.
  5. * T1 with pathologic high-risk features (lymphovascular invasion \[LVI\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)
  6. * Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)
  7. * Restaging TURBT must be performed and must meet ALL of the following criteria below:
  8. * If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.
  9. * All grossly visible papillary tumors must be removed
  10. * Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial
  11. * No pure squamous cell carcinoma or adenocarcinoma of the bladder
  12. * No neuroendocrine (small or large cell) features
  13. * No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)
  14. * No prostatic urethral involvement
  15. * Age ≥ 18
  16. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  17. * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal
  18. * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  19. * Platelets ≥ 100,000 cells/mm\^3
  20. * Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 9 g/dl is acceptable)
  21. * Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels \> 1.5 × institutional ULN
  22. * Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
  23. * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
  24. * All adverse events of their most recent therapy/intervention must have resolved to \< grade 3 or returned to baseline prior to registration
  25. * No history of pelvic radiation therapy
  26. * No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed
  27. * No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
  28. * No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \[COVID\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible
  29. * Patients must have recovered from acute cardiac illness
  30. * New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
  31. * No active infection requiring IV antibiotics
  32. * No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  33. * No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis
  34. * No history of allogeneic bone marrow transplant or prior solid organ transplant
  35. * No active tuberculosis
  36. * No evidence of hydronephrosis
  37. * No history of upper tract urothelial carcinoma within 24 months of registration
  38. * No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)
  39. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  40. * No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable
  41. * No history of allergic reaction to the drug excipients
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Brian C Baumann
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301
United States
Shaw Cancer Center
Edwards, Colorado, 81632
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, 70002
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Brian C Baumann, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-12-02
Study Completion Date2032-02-01

Study Record Updates

Study Start Date2025-12-02
Study Completion Date2032-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
  • Stage I Bladder Cancer AJCC v8