Oracle Runs

Oracle findings and outcome history for A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy (NCT06797297).

Runs

Findings

Latest Run

Apr 6, 2026, 2:57 PM

All Oracle Findings

Every stored oracle finding for this trial, including pending, dismissed, rejected, superseded, and accepted items.

NO_DECISIONDismissed90% confidenceGrok 4.20 (xAI)

Will the results be positive?

Trial (NCT06797297) is recruiting with estimated primary completion in Mar 2026. ASCO 2025 abstract is 'trial in progress' describing design only; no efficacy readout or results posted. Prior IBI363 data in IO-treated or other melanoma cohorts are positive but not for this exact Phase 2 head-to-head in IO-naive patients.

Found Apr 6, 2026, 2:10 PMReviewed Apr 6, 2026, 2:19 PM

Web Searchascopubs.orgMay 28, 2025, 12:00 AM

A multicenter, randomized, controlled, open-label, phase 2 study of the PD-1/IL-2 α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma

Trial in progress abstract for this exact randomized Phase 2 study of IBI363 monotherapy vs pembrolizumab. No results or efficacy data; only study design and endpoints described.

Web Searchclinicaltrials.gov

NCT06797297 Study Details

Current status: Recruiting. Estimated primary completion: 2026-03-31. No results posted.

NO_DECISIONDismissed90% confidencemanual-chat-review

Will the results be positive?

ClinicalTrials.gov still lists this study as recruiting with no posted results, so there is not yet a clear public positive or negative trial readout.

Found Apr 4, 2026, 8:54 PMReviewed Apr 4, 2026, 10:32 PM

ClinicalTrialsclinicaltrials.govApr 4, 2025, 12:00 AM

Study Details | NCT06797297 | ClinicalTrials.gov

ClinicalTrials.gov lists recruiting; primary completion 2026-03-31; hasResults=false on the latest posted update.

NO_DECISIONDismissed96% confidenceGPT-5.4 (OpenAI)

Will the results be positive?

No public, trial-specific efficacy readout was found for NCT06797297. The cited sources indicate the study is/was being initiated and ongoing, with first patient dosed in March 2025, so there is not enough exact-trial evidence to label the readout positive or negative.

Found Apr 3, 2026, 4:31 PMReviewed Apr 3, 2026, 4:46 PM

ClinicalTrialsclinicaltrials.gov

Study Details | NCT06797297 | ClinicalTrials.gov

ClinicalTrials.gov lists NCT06797297 as the study record for this Phase 2 head-to-head melanoma trial; no public results/readout are shown in the surfaced record.

Sponsorprnewswire.comMar 6, 2025, 12:00 AM

Head-to-Head Against Pembrolizumab: Innovent Announces First Patient Dosed in the First Pivotal Study of IBI363 in Melanoma

Sponsor-linked release says the first pivotal study was initiated and the first patient was dosed; this is start-up/ongoing status, not a trial-specific efficacy readout.

NO_DECISIONDismissed95% confidenceGPT-5.4 (OpenAI)

Will the results be positive?

No trial-specific public efficacy readout was found for NCT06797297. The cited sources indicate the study was still being initiated/recruiting and described as underway/first pivotal study, while positive comments refer to earlier IBI363 studies, not this exact head-to-head Phase 2 trial.

Found Apr 1, 2026, 8:21 PMReviewed Apr 1, 2026, 8:22 PM

ClinicalTrialsclinicaltrials.gov

Study Details | NCT06797297 | ClinicalTrials.gov

ClinicalTrials.gov lists NCT06797297 as a Phase II randomized study of IBI363 vs pembrolizumab with primary completion date March 31, 2026; no trial-specific results/readout are shown in the cited record snippet.

Sponsorprnewswire.comMar 31, 2025, 1:19 AM

Innovent Receives NMPA Breakthrough Therapy Designation for IBI363 in Melanoma

Innovent said it had recently initiated and dosed the first patient in this first pivotal study; the efficacy language in the release is tied to two earlier trials, not NCT06797297.

Sponsorinvestor.innoventbio.com

Innovent Biologics 2024 Annual Results Presentation

Sponsor slide deck says for IBI363 melanoma: 'First pivotal study initiated (H2H Pembrolizumab) in IO-naïve melanoma,' indicating the exact trial had started but had not publicly read out.

Outcome History

Public history of accepted oracle reviews and recorded outcome changes for this trial.

No oracle outcome history is available for this trial yet.