ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer

NCT07551544 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: ResQ1320-NMIBC
• Study Type: interventional
• Target: 688
• Locations: 0 countries
• Sites: N/A

Brief 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. The purpose of this study is to evaluate the contribution of effect of neoadjuvant ANKTIVA plus BCG experimental therapy in papillary NMIBC.

Conditions

NMIBC

Outcome Measures

Primary Outcomes (2)

• Clinical Complete Response (CR) Rate

  First response assessment, as determined by Investigator assessment of cystoscopy, cytology, and biopsy as clinically indicated

  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.

  Approximately 36 months

Study Arms (2)

BCG + ANKTIVA

EXPERIMENTAL

Biological: BCG (50 mg) plus ANKTIVA (400 µg)

BCG only

ACTIVE COMPARATOR

Biological: BCG (50 mg)

Interventions

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 + ANKTIVA

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.

BCG only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 27, 2026

Record last verified: 2026-04