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

NCT07551544 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

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 (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.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2032-05-31
Completion
2032-05-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551544 on ClinicalTrials.gov