ANKTIVA Plus BCG Versus BCG Monotherapy in High-Grade Non-Muscle Invasive Papillary Bladder Cancer, Phase 3 Study
Summary
NIH registered a Phase 3 clinical trial (NCT07551544) on April 27, 2026, evaluating intravesical ANKTIVA (400µg) plus BCG (50mg) against BCG monotherapy (50mg) in participants with histologically confirmed BCG-naïve or BCG-exposed high-grade Ta/T1 papillary non-muscle invasive bladder cancer. The open-label, randomized study will assess the contribution of ANKTIVA as an experimental neoadjuvant therapy in papillary NMIBC.
“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.”
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What changed
NIH registered a new Phase 3 clinical trial on ClinicalTrials.gov involving ANKTIVA (nogapendekin alfa inbakicept) combined with BCG for the treatment of high-grade non-muscle invasive bladder cancer. The trial is randomized and open-label, comparing the experimental arm of ANKTIVA plus BCG against the control arm of BCG monotherapy in participants with confirmed papillary disease. No compliance obligations are created by this registration; the document serves as an informational record of ongoing clinical research.
Affected parties include clinical investigators conducting bladder cancer research, pharmaceutical companies developing bladder cancer therapeutics, and healthcare providers treating NMIBC patients who may consider trial enrollment. The registration provides protocol details but imposes no regulatory requirements on external parties.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
Phase 3 NCT07551544 Kind: PHASE3 Apr 27, 2026
Abstract
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
Interventions: BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
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