Immunotherapy + Radiation for Bladder Cancer
(RAD-VACCINE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRaj Satkunasivam, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: The Methodist Hospital Research Institute
Must not be taking: Corticosteroids, Immunosuppressants, others
Disqualifiers: Metastatic disease, Autoimmune disease, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new treatment combining Sasanlimab, which helps the immune system fight cancer, with targeted radiation therapy. It is for patients with muscle-invasive bladder cancer who cannot receive standard chemotherapy. The treatment aims to boost the immune response and directly target cancer cells with radiation.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications like corticosteroids or other immunosuppressive drugs, you may need to stop them 14 days before starting the study treatment.
What data supports the effectiveness of this treatment for bladder cancer?
Research shows that radical cystectomy (surgical removal of the bladder) combined with pelvic lymph node dissection is a standard and effective treatment for muscle-invasive bladder cancer, with studies evaluating long-term outcomes and survival rates in patients.
12345Is the combination of immunotherapy and radiation for bladder cancer generally safe for humans?
Research indicates that radical cystectomy and urinary diversion, especially after high-dose pelvic radiation, can have high complication rates. However, a study found that high-dose, short-course preoperative radiation followed by immediate cystectomy did not increase operative morbidity (complications) or mortality (death rates).
25678How is the treatment of Immunotherapy + Radiation for Bladder Cancer different from other treatments?
This treatment is unique because it combines immunotherapy, which helps the immune system fight cancer, with radiation therapy, which uses high-energy rays to kill cancer cells, before surgery. This combination aims to enhance the tumor response and potentially improve outcomes for patients with advanced bladder cancer, without increasing side effects.
6791011Eligibility Criteria
This trial is for adults with muscle-invasive bladder cancer who can't have cisplatin chemotherapy. They need good bone marrow and kidney function, no severe infections or heart issues recently, and no history of certain autoimmune diseases or other cancers in the last 2 years. Participants must be willing to use effective contraception.Inclusion Criteria
More than half of my cancer is urothelial carcinoma.
I can take care of myself and perform daily activities.
I am able to understand and sign the consent form.
+8 more
Exclusion Criteria
I have an active heart condition.
I have had radiation therapy to my bladder before.
I have had an organ or stem cell transplant.
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 2 doses of sasanlimab followed by 3 doses of stereotactic body radiation therapy
6 weeks
5 visits (in-person)
Surgery
Participants undergo radical cystectomy within 6 weeks of the last dose of sasanlimab
Within 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and quality of life
12 weeks
3 visits (in-person)
Long-term follow-up
Participants are monitored for overall survival and recurrence-free survival
24 months
Participant Groups
The study tests Sasanlimab (an immune checkpoint inhibitor) combined with stereotactic body radiation therapy before surgery for bladder cancer. It's a phase II trial where all participants receive this combination as a potential 'in-situ vaccine' to boost their immune response against the cancer.
1Treatment groups
Experimental Treatment
Group I: Open armExperimental Treatment3 Interventions
All patients will receive study interventions (sasanlimab and SBRT) and standard-of-care radical cystectomy.
Radical Cystectomy + Pelvic Lymph Node Dissection + Urinary Diversion is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Radical Cystectomy with Pelvic Lymph Node Dissection and Urinary Diversion for:
- Muscle-invasive bladder cancer
🇪🇺 Approved in European Union as Radical Cystectomy with Pelvic Lymph Node Dissection and Urinary Diversion for:
- Muscle-invasive bladder cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Houston Methodist HospitalHouston, TX
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Who Is Running the Clinical Trial?
The Methodist Hospital Research InstituteLead Sponsor
PfizerIndustry Sponsor
References
[Radical cystectomy in the treatment for bladder carcinoma: results of 125 operated patients]. [2007]Radical cystectomy with pelvic lymphadenectomy and urinary diversion is standard treatment in patients with muscle-invasive and selected high-risk superficial bladder cancers. The aim of our study was to evaluate oncological results and correlate prognosis with the extent of the disease.
Radical Cystectomy for Bladder Cancer in Patients With and Without a History of Pelvic Irradiation: Survival Outcomes and Diversion-related Complications. [2015]To compare survival outcomes and diversion-related complications of patients with and without a history of pelvic irradiation who underwent radical cystectomy.
Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. [2023]To evaluate our long-term experience with patients treated uniformly with radical cystectomy and pelvic lymph node dissection for invasive bladder cancer and to describe the association of the primary bladder tumor stage and regional lymph node status with clinical outcomes.
Radical Cystectomy in the Treatment of Invasive Bladder Cancer: Long-Term Results in 1,054 Patients. [2023]To evaluate our long-term experience with patients treated uniformly with radical cystectomy and pelvic lymph node dissection for invasive bladder cancer and to describe the association of the primary bladder tumor stage and regional lymph node status with clinical outcomes.
Urinary bladder cancer treated with radical cystectomy: perioperative parameters and early complications prospectively registered in a national population-based database. [2022]Cystectomy combined with pelvic lymph-node dissection and urinary diversion entails high morbidity and mortality. Improvements are needed, and a first step is to collect information on the current situation. In 2011, this group took the initiative to start a population-based database in Sweden (population 9.5 million in 2011) with prospective registration of patients and complications until 90 days after cystectomy. This article reports findings from the first year of registration.
Early complications of cystectomy after high dose pelvic radiation. [2010]Radical cystectomy in patients with a history of pelvic radiation therapy is often a challenging and morbid procedure. We report early complication rates in patients undergoing cystectomy and urinary diversion after high dose pelvic radiation.
Experience with high dose, short course preoperative radiation therapy and immediate single stage cystectomy in management of bladder cancer: a preliminary report. [2006]This preliminary report concerns our experience with the use of high dose, short course preoperative radiation therapy and immediate single state cystectomy for the management of bladder cancer. Data reveal that 1,660 rad delivered in 4 days and followed by immediate cystectomy do not increase operative morbidity or mortality. The operative mortality and morbidity of a single stage radical cystectomy with en bloc pelvic node dissection and urinary diversion are no greater than that reported for less radical procedures without node dessection. In this series the incidence of nodal involvement ranged from 10 percent for PIS and P1 tumors to 50 per cent for P3 tumors, implying the need for treatment of pelvic nodes whenever cystectomy seems indicated.
Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy. [2022]Comprehensive and standardized reporting of adverse events after robot-assisted radical cystectomy (RARC) and urinary diversion for bladder cancer is necessary to evaluate the magnitude of morbidity for this complex operation.
[Combination radiotherapy-immunotherapy in genitourinary cancer]. [2021]Immunotherapy occupies a growing place in urologic oncology, mainly for kidney and bladder cancers. On the basis of encouraging preclinical work, the combination of immunotherapy with radiotherapy aims to increase the tumor response, including in metastatic tumors, which raises many hopes, which this article reviews.
Radiation therapy before radical cystectomy combined with immunotherapy in locally advanced bladder cancer - study protocol of a prospective, single arm, multicenter phase II trial (RACE IT). [2020]Patients with locally advanced bladder cancer (cT3/4 cN0/N+ cM0) have a poor prognosis despite radical surgical therapy and perioperative chemotherapy. Preliminary data suggest that the combination of radiation and immunotherapy does not lead to excess toxicity and may have synergistic (abscopal) anti-tumor effects. We hypothesize that the combined preoperative application of the PD-1 checkpoint-inhibitor Nivolumab with concomitant radiation therapy of the bladder and pelvic region followed by radical cystectomy with standardized lymphadenectomy is safe and feasible and might improve outcome for patients with locally advanced bladder cancer.
The delivery of radical radiotherapy to the bladder and pelvis in node-positive (N1) bladder cancer: a five patient case series. [2022]In the UK over 10,000 new cases of bladder cancer were diagnosed in 2012, making it the seventh most common cancer in the UK. For those with advanced disease at presentation, prognosis is poor. Disease presenting with one pathological node (N1) is considered to be Stage 4 and is therefore considered the same as disease with widespread metastases. Pelvic lymph node dissection is considered standard when performing radical cystectomy; however, owing to potential toxicity, pelvic radiotherapy is not routine even when attempting radical treatment. We present five cases where radical treatment has been delivered to patients with node-positive bladder cancer. Treatment volumes included the whole bladder and bilateral pelvic nodes, and where it was felt appropriate, chemotherapy was delivered concurrently. Data has been collected by reviewing hospital notes including radiotherapy, volumes and dose distributions. Treatment was tolerated well with only minimal gastrointestinal and urinary symptoms reported. Three of the five patients had thrombocytopenia. This complication may be explained by the larger volume of radiation exposure. Local control appears to be good with all the patients having no pelvic relapse at the time of reporting. Two patients have relapsed with distant metastatic disease. No long-term side effects of therapy have been reported. Intensity-modulated radiotherapy techniques allow larger volumes to be treated owing to improved conformality and the resulting reduced toxicity. Treatment may be appropriate with both radical and adjuvant doses of radiation. More work is necessary to assess which patients would benefit and are most suitable for such treatment.