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Urothelial Carcinoma BladderPhase 2RAD-VACCINENCT05241340

Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer

A Phase 2 study testing Sasanlimab, Stereotactic Body Radiation Therapy and Radical Cystectomy + pelvic lymph node dissection + urinary diversion in people with Urothelial Carcinoma Bladder, run by The Methodist Hospital Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, single-institution, single-arm, phase II clinical trial that tests a novel strategy of neoadjuvant Sasanlimab, an immune checkpoint inhibitor (ICI), in combination with stereotactic body radiation therapy as an in-situ vaccination in patients, who are ineligible to receive cisplatin-based… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma Bladder
What is being tested?
Sasanlimab, Stereotactic Body Radiation Therapy and Radical Cystectomy + pelvic lymph node dissection + urinary diversion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
15 Feb 2022to 1 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent
  • Age ≥ 18 years
  • ECOG Eastern Cooperative Oncology Group performance status 0-2
  • Predominant (>50%) urothelial carcinoma histology
  • Muscle-invasive bladder cancer (cT2-4a, cN0, cM0)
  • Decline/refuse OR Ineligible to receive cisplatin-based Neoadjuvant Chemotherapy due to at least one of the following criteria:
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  • Creatinine clearance less than 60 mL/min b. Eastern Cooperative Oncology Group performance status of ≥ 2 c. Grade ≥ 2 hearing loss d. Grade ≥ 2 neuropathy
  • Adequate Bone Marrow Function (without hematopoietic growth factor support within 14 days prior to study screening), defined as:
  • Absolute neutrophil count (ANC) ≥1,500/mm3 or ≥1.5 x 109/L b. Platelets ≥100,000/mm3 or 100 x 109/L c. Hemoglobin ≥9 g/dL (≥5.6 mmol/L)
  • Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min according to the Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance.
  • Adequate liver function, including:
  • Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × the upper normal limit range (ULN) b. Total serum bilirubin ≤ 1.5 x ULN
  • Able to give informed consent and patient is willing and able to comply with scheduled study visits and treatment plan
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
  • Meeting the following criteria for sex specific considerations:
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  • Males - for the duration of study and for at least 6 months after the last dose of study drug (Sasanlimab):
  • Refrain from donating sperm and be abstinent from intercourse OR Agree to use male condom and also consider the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant
  • Females:
  • Eligible to participate if not pregnant or breast feeding AND Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and is using a contraceptive method that is highly effective (failure rate of < 1% per year), with low user dependency during the during the study treatment and for at least 6 months after the last dose of study drug (Sasanlimab) b) A WOCBP must have a negative, highly sensitive (at least 25 IU/mL) pregnancy test by urine or serum testing within 24 hours before the first dose of study drug (Sasanlimab). In cases where the urine test cannot be confirmed to be negative, a serum pregnancy test will be used.

Who cannot join

  • Lymphadenopathy (>1cm short-axis measurement on CT/MRI Imaging or biopsy proven)
  • Metastatic disease
  • Prior systemic chemotherapy for bladder cancer (however, may have had intra-vesical chemotherapy such as gemcitabine, docetaxel or mitomycin-C)
  • Prior treatment with systemic anti-cancer investigational agent
  • Other malignancy within 2 years prior to study screening, or active malignancy except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance without any plans for treatment intervention (e.g., surgery, radiation, or castration) or other concurrent malignancy felt by the investigator has a very low likelihood to become metastatic
  • Previous radiation therapy to the bladder
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  • Active or history of autoimmune disease which may deteriorate when receiving immune checkpoint blockade.
  • These autoimmune conditions include but are not limited to limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
  • Participants with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Severe active infections (e.g., pulmonary tuberculosis) requiring systemic therapeutic oral or IV antibiotics within 2 weeks prior to study entry.
  • Clinically significant, multiple or severe drug allergies, intolerance to topical corticosteroids
  • Current unstable liver or biliary disease, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
  • NOTE: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HBsAg] or positive hepatitis C antibody test result at screening) is acceptable.
  • Active, uncontrolled HIV/AIDS infection (well-controlled HIV patients may be allowed).
  • Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4) antibody. Note: prior intra-vesical BCG therapy is acceptable.
  • Prior treatment with immune-stimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)- γ.
  • Vaccination within 4 weeks from study screening and while on study treatment unless administration of inactivated vaccines.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Clinically significant (active) cardiovascular disease including the following: cerebral vascular accident/stroke <6 months prior to screening; myocardial infarction <6 months prior to screening; unstable angina; congestive heart failure (≥New York Heart Association Classification Class III); or serious cardiac arrhythmia (uncontrolled, clinically significant) requiring medication.
  • Q-T interval corrected for heart rate (QTc) >450 msec for male participants or QTc >470 msec for female participants or QTc >480 msec in participants with right bundle branch block
  • Prior organ transplantation or allogenic stem cell transplantation.
  • Known history of: immune-mediated colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.
  • Patients with intolerance to or who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or infused therapeutic proteins
  • Pregnant female patients; breastfeeding female patients; male patients able to father children and female patients of childbearing potential who are unwilling or unable to use a highly effective method(s) of contraception as outlined in this protocol for at least 6 months after the last dose of Sasanlimab (PF-06801591)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Houston Methodist Hospital

    Houston, Texas, 77006

Other trials in United States

About this study

Official title: A Phase II Clinical Trial of Neoadjuvant Sasanlimab and Stereotactic Body Radiation Therapy as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer

This is a prospective, single-institution, single-arm, phase II clinical trial that tests a novel strategy of neoadjuvant Sasanlimab, an immune checkpoint inhibitor (ICI), in combination with stereotactic body radiation therapy as an in-situ vaccination in patients, who are ineligible to receive cisplatin-based chemotherapy and undergoing radical cystectomy for muscle-invasive bladder cancer.

Read the detailed description

Patients with cT2-T4a, N0, M0 urothelial bladder carcinoma (UBC) after transurethral resection of the bladder will receive 2 doses of sasanlimab (PF-06801591) at the dose of 300mg subcutaneously, followed by 3 doses of radiation (8Gy x 3) prior to surgery (radical cystectomy). Cystectomy will be planned to be done within 6 weeks of the last dose of sasanlimab.

Pathologic complete response (pT0) is the primary endpoint, in addition to a safety lead-in endpoint consisting of a composite outcome of feasibility and safety.

Exploratory biomarker analysis on tissue/blood samples will include genomic and immune-system profiling in tumor and blood before and after sasanlimab/radiation therapy, and after radical cystectomy.

Being tested
Sasanlimab, Stereotactic Body Radiation Therapy, Radical Cystectomy + pelvic lymph node dissection + urinary diversion
Keywords
Bladder Cancer, Muscle Invasive Bladder Cancer, Immune Checkpoint Inhibitor, Immunotherapy, Urothelial Carcinoma of the Bladder, Urologic neoplasms, Neoadjuvant therapy, Radiation, Stereotactic Body Radiation Therapy, Urinary Bladder Diseases, Urologic Diseases, Sasanlimab, Antineoplastic agents, Antineoplastic agents, Immunological
Medical subject headings
Urinary Bladder Neoplasms, Urologic Neoplasms, Urinary Bladder Diseases, Urologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SasanlimabDrug

    Also called PF-06801591, PD-1 Inhibitor

    Sasanlimab (PF-06801591) is a recombinant humanized monoclonal antibody (immunoglobulin gamma-4 with kappa light chains, IgG4 kappa) directed against programmed death 1 (PD-1). Manufactured by Pfizer, Inc.

  • Stereotactic Body Radiation TherapyRadiation

    This current study is designed to deliver a biologically equivalent dose of 43.2Gy using a strategy of HD hypo-fractionated radiation therapy 8Gy x 3 in combination with Sasanlimab

  • Radical Cystectomy + pelvic lymph node dissection + urinary diversionProcedure or surgery

    This will include a cysto-prostatectomy in males or a radical cystectomy with anterior exenteration in females, bilateral pelvic lymph node dissection, and creation of a urinary diversion (ileal conduit, Indiana pouch or orthotopic neo-bladder). Robotic assisted or open surgery will be permitted.

    Because there is currently equipoise regarding standard or extended template pelvic lymph node dissection, the limits of node dissection will not be protocol mandated. In the standard template, nodal packets will include the common iliac, external iliac, internal iliac (or hypogastric) and obturator nodes. Patients receiving an extended template will have the standard nodes with the addition of the para-aortic, para-caval, pre-sacral, and pre-sciatic node packets. The decision for urinary diversion is multifactorial involving patient factors (e.g., adequate renal function) and preference; thus, it will be made on a case-by-case basis.

Study groups in NCT05241340
Study groupRoleWhat they receive
Open armExperimentalAll patients will receive study interventions (sasanlimab and SBRT) and standard-of-care radical cystectomy.
Receives: Drug: Sasanlimab; Radiation: Stereotactic Body Radiation Therapy; Procedure: Radical Cystectomy + pelvic lymph node dissection + urinary diversion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome for Feasibility and Safety

    Combination of Sasanlimab and SBRT will be deemed both feasible and safe (composite outcome) if, after the treatment of 10 patients, ≥ 7 of 10 patients meet all of the following feasibility criteria:

    1. Receive at least 1 dose of 2 of Sasanlimab
    2. Receive at least 2 of 3 fractions SBRT
    3. Undergo radical cystectomy RC within 4 weeks of completing therapy (after end of cycle 2) and meet all of the safety criteria, defined as not experiencing any following Common Terminology Criteria for Adverse Events (CTCAE) toxicities up to 4 weeks after the completion of radical cystectomy:
    4. Hematologic toxicity ≥ Grade 4
    5. Non-hematologic toxicity ≥ Grade 3
    6. Non-hematologic toxicity ≥ Grade 2 lasting >1 week (except alopecia, emesis, and laboratory abnormalities)

    Measured: From date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy

  2. Clinical benefit rate defined as pathologic complete response (pT0)

    Proportion of patients experiencing pathologic complete response (pT0) after the study treatment followed by radical cystectomy.

    Measured: At time of radical cystectomy

Secondary outcomes (5)

  1. Incidence of adverse events graded by NCI CTCAE version 5.0

    Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From date of registration to date of death due to any cause, assessed up to 12 weeks after radical cystectomy

  2. Incidence of major surgical complications graded by Clavien-Dindo Scale

    Clavien-Dindo scale is widely utilized for grading adverse events (i.e. complications) that may occur as a result of surgical procedures.

    The severity of the complication increases from grade 1 to grade 5.

    Measured: From date of radical cystectomy to date of death, assessed up to 30 days following surgery

  3. Health Related Quality of Life for Patients with T2-T4 muscle invasive bladder cancer

    Patient's health related quality of life survey on 30 items including urinary symptoms, sexual function, urostomy issues, catheter use, and body image will be assessed by The European Organization for Research and Treatment of Cancer (EORTC) QOL C30-BLM 30, in order to assess changes in patient-reported quality of life at baseline and changes.

    Each item is scored on a 4 point scale, with a higher score reflecting a better quality of life.

    Measured: From date of registration to date of death due to any cause, assessed up to 24 months after radical cystectomy

  4. Overall survival (OS)

    Overall Survival is defined as the duration of time from the date of treatment initiation that a patient is still alive.

    Measured: From date of registration to date of death due to any cause, assessed up to 24 months after radical cystectomy

  5. Recurrence free survival (RFS)

    RFS is defined as the time from surgery and study treatment to recurrence or death, whichever occurred first.

    Measured: From date of registration to date of death due to any cause, assessed up to 24 months after radical cystectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start15 Feb 2022
  3. Primary completion1 Aug 2025
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241340
Sponsor's protocol ID
PRO00032433
Acronym
RAD-VACCINE
Status last verified
Oct 2025
First submitted
19 Jan 2022
Last updated
24 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Satkunasivam R, Lim K, Teh BS, Guzman J, Zhang J, Farach A, Chen SH, Wallis CJ, Efstathiou E, Esnaola NF, Sonpavde GP. A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an in situ vaccine for cisplatin-ineligible MIBC: the RAD VACCINE MIBC trial. Future Oncol. 2022 Aug;18(25):2771-2781. doi: 10.2217/fon-2022-0380. Epub 2022 Jun 15.

    PubMed 35703113

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sasanlimab, Stereotactic Body Radiation Therapy and Radical Cystectomy + pelvic lymph node dissection + urinary diversion in people with Urothelial Carcinoma Bladder, run by The Methodist Hospital Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome for Feasibility and Safety (time frame: From date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05241340, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.

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