NMIBCPhase 3NCT07551544
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
A Phase 3 study testing BCG (50 mg) plus ANKTIVA (400 µg) and BCG (50 mg) in people with NMIBC, run by ImmunityBio, Inc..
Trial summary
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1 papillary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMIBC
- What is being tested?
- BCG (50 mg) plus ANKTIVA (400 µg) and BCG (50 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to May 2032
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologic confirmation of NMIBC of the urothelial carcinoma HG subtype (mixed histology tumors allowed if transitional cell histology is predominant histology), including histologically confirmed presence of HG Ta or T1 papillary disease only.
- No concurrent CIS at TURBT #1 during screening.
- Visually complete TURBT #1 per Investigator.
- BCG-naive disease, defined as either of the following:
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- Have not received prior intravesical BCG; or
- Previously received BCG but stopped receiving more than 3 years before date of randomization.
- BCG-exposed disease, defined as patients who have received at least 1 dose of BCG and do not meet the BCG-unresponsive criteria.
- Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males. Female participants of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male participants must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), 2 forms of barrier methods (eg, condom, diaphragm) used with spermicide, and intrauterine devices (IUDs).
- Voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
Who cannot join
- Life expectancy < 2 years.
- BCG-unresponsive disease, defined as:
- Persistent or recurrent CIS (± recurrent Ta/T1 disease) within 12 months of receiving adequate BCG (at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course); or
- Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course); or
- T1 high-grade disease at the first evaluation following an induction BCG course alone (at least 5 of 6 doses of an initial induction course)
- Urinary tract infection or urinary retention.
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- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis/calyces). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization.
- Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the Investigator, may prevent the safe administration of intravesical N-803 or BCG. Participants with tumors involving the prostatic urethra in men will be excluded.
- History of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL).
- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable.
- History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of prostatic urethra); or any other cancer within the past 5 years that is progressing or requires active treatment. Exceptions are adequately treated basal cell or squamous cell skin cancer that has undergone potentially curative therapy or in situ cervical cancer; and adequately treated stage I or II cancer or stable prostate cancer from which the participant is currently in complete remission and is under active surveillance.
- Receiving investigational or commercial anticancer agents or anticancer therapies other than supportive care therapies for active disease within 28 days of enrollment.
- Concurrent use of other investigational agents.
- Concurrent febrile illness, active tuberculosis, a history of hypotension of anaphylactic reactions.
- Ongoing chronic systemic steroid therapy required (> 10 mg prednisone daily or equivalent).
- Women who are pregnant and nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study for 90 days post last dose of study drug.
- Other illnesses or conditions, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.
About this study
Official title: Open Label Randomized Phase 3 Clinical Trial Of ANKTIVA In Combination With Intravesical BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1 papillary disease. The purpose of this study is to evaluate the contribution of effect of neoadjuvant ANKTIVA plus BCG experimental therapy in papillary NMIBC.
- Conditions
- NMIBC
- Being tested
- BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG (50 mg) plus ANKTIVA (400 µg)Biological
First (Priming) Treatment Period:
50 mg BCG plus 400 µg ANKTIVA intravesically, weekly for 3 consecutive weeks
Second (Induction) Treatment Period:
50 mg BCG plus 400 µg ANKTIVA intravesically, weekly for 6 consecutive weeks
Third (Re-Induction or Maintenance) Treatment Period:
50 mg BCG plus 400 µg ANKTIVA intravesically, weekly for 6 consecutive weeks
BCG (50 mg)Biological
First (Priming) Treatment Period:
50 mg BCG intravesically, weekly for 6 consecutive weeks
Second (Induction) Treatment Period:
Participants may be eligible for additional treatment during the second treatment period depending upon the results of the second response assessment (week 21).
Third (Re-Induction or Maintenance) Treatment Period:
Participants may be eligible for additional maintenance treatment during the third treatment period depending upon the results of the week 33 and subsequent response assessments, which occur every 3 months through month 6 and every 6 months thereafter through month 36.
| Study group | Role | What they receive |
|---|---|---|
| BCG + ANKTIVA | Experimental | Not described Receives: Biological: BCG (50 mg) plus ANKTIVA (400 µg) |
| BCG only | Active comparator | Not described Receives: Biological: BCG (50 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response (CR) Rate
First response assessment, as determined by Investigator assessment of cystoscopy, cytology, and biopsy as clinically indicated
Measured: Study Week 7
Disease Free Survival
DFS, defined as the time from randomization until recurrence of HG Ta (excluding LG Ta) disease or any grade T1 disease, new CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death due to any cause, whichever occurs first, regardless of re-induction.
Measured: Approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completionMay 2032 (estimated)
- Study completionMay 2032 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551544
- Sponsor's protocol ID
- ResQ1320-NMIBC
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Phase 3 Clinical Trial Of ANKTIVA In Combination With Intravesical BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
- ClinicalTrials.gov ID
- NCT07551544
- Acronym / sponsor ID
- ResQ1320-NMIBC
- Conditions
- NMIBC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1 papillary disease. The purpose of this study is to evaluate the contribution of effect of neoadjuvant ANKTIVA plus BCG experimental therapy in papillary NMIBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCG + ANKTIVA | Experimental | Biological: BCG (50 mg) plus ANKTIVA (400 µg) |
| BCG only | Active comparator | Biological: BCG (50 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologic confirmation of NMIBC of the urothelial carcinoma HG subtype (mixed histology tumors allowed if transitional cell histology is predominant histology), including histologically confirmed presence of HG Ta or T1 papillary disease only.
- No concurrent CIS at TURBT #1 during screening.
- Visually complete TURBT #1 per Investigator.
Key exclusion criteria (17 listed)
- Life expectancy < 2 years.
- BCG-unresponsive disease, defined as:
- Urinary tract infection or urinary retention.
- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis/calyces). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization.
- Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the Investigator, may prevent the safe administration of intravesical N-803 or BCG. Participants with tumors involving the prostatic urethra in men will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG (50 mg) plus ANKTIVA (400 µg)First (Priming) Treatment Period: 50 mg BCG plus 400 µg ANKTIVA intravesically, weekly for 3 consecutive weeks Second (Induction) Treatment Period: 50 mg BCG plus 400 µg ANKTIVA intravesically, weekly for 6 consecutive weeks Third (Re-Induction or Maintenance) Treatment Period: 50 mg BCG plus 400 µg ANKTIVA intravesically, weekly for 6 consecutive weeks | Biological | BCG + ANKTIVA |
| BCG (50 mg)First (Priming) Treatment Period: 50 mg BCG intravesically, weekly for 6 consecutive weeks Second (Induction) Treatment Period: Participants may be eligible for additional treatment during the second treatment period depending upon the results of the second response assessment (week 21). Third (Re-Induction or Maintenance) Treatment Period: Participants may be eligible for additional maintenance treatment during the third treatment period depending upon the results of the week 33 and subsequent response assessments, which occur every 3 months through month 6 and every 6 months thereafter through month 36. | Biological | BCG only |
Primary outcome
Clinical Complete Response (CR) Rate
Time frame: Study Week 7
First response assessment, as determined by Investigator assessment of cystoscopy, cytology, and biopsy as clinically indicated
Disease Free Survival
Time frame: Approximately 36 months
DFS, defined as the time from randomization until recurrence of HG Ta (excluding LG Ta) disease or any grade T1 disease, new CIS, disease progression, cystectomy, change in therapy indicative of more advanced disease, or death due to any cause, whichever occurs first, regardless of re-induction.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG (50 mg) plus ANKTIVA (400 µg) and BCG (50 mg) in people with NMIBC, run by ImmunityBio, Inc..
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 11 inclusion and 17 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: withdrawn, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Complete Response (CR) Rate (time frame: Study Week 7). 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?
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 19 May 2026.