Trial · NCT06797297
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, Phase 2, Active not recruiting, Innovent Biologics (Suzhou) Co. Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT06797297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06797297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT06797297
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 203 participants, actual
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Conditions
- Melanoma
- Interventions
- IBI363, Pembrolizumab
- First posted
- 2025-01-28
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IRRC-Progression Free Survival(PFS) | up to 2 years | Progression Free Survival assessed by Independent Radiology Review Committee (IRRC-PFS), Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Secondary | INV-Progression Free Survival(PFS) | up to 2 years | Progression Free Survival assessed by Investigator, Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Secondary | Objective Response Rate (ORR) | up to 2 years | Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator. |
| Secondary | Duration of Response (Duration Of Response) | up to 2 years | DOR in two arms based on RECIST V1.1 by IRRC and investigator. |
| Secondary | Disease Control Rate (DCR) | up to 2 years | DCR in two arms based on RECIST V1.1 by IRRC and investigator. |
| Secondary | Time to Response (TTR) | up to 2 years | TTR in two arms based on RECIST V1.1 by IRRC and investigator. |
| Secondary | Overall Survival (OS) | up to 2 years | Overall survival in two arms |
| Secondary | safety indicators during the treatment | up to 2 years | Number of participants with Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Immune-related AE (irAE), Serious Adverse Event (SAE), treatment-emergent AE leading to treatment termination, death, and related with investigational agent |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06797297
GET https://conductscience.org/api/trials/v1/NCT06797297/registered