Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
NCT07915258, Phase 2, Not yet recruiting, Sun Yat-sen University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy | ClinicalTrials.gov |
| NCT number | NCT07915258 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 22 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sun Yat-sen University | ClinicalTrials.gov |
| Conditions | Squamous Cell Carcinoma of Head and Neck (SCCHN) | ClinicalTrials.gov |
| Interventions | Becotatug Vedotin (MRG003), Pucotenlimab | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From baseline to preoperative tumor assessment after two treatment cycles (approximately 6-10 weeks after the first dose) | The proportion of participants achieving a complete response (CR) or partial response (PR), as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), based on radiological assessments before and after adaptive neoadjuvant treatment. The ORR will be reported with an exact 95% confidence interval using the Clopper-Pearson method. | ClinicalTrials.gov |
| Secondary | Pathological Complete Response Rate (pCR) | At curative-intent surgery, approximately 6-12 weeks after the first study dose | The proportion of participants with no residual viable invasive tumor cells in the primary tumor bed and all regional lymph nodes, as determined by histopathological examination of surgical specimens. | ClinicalTrials.gov |
| Secondary | Major Pathological Response Rate (MPR) | At curative-intent surgery, approximately 6-12 weeks after the first study dose | The proportion of participants with 10% or less residual viable tumor cells in the resected tumor tissue, as assessed by histopathological examination. | ClinicalTrials.gov |
| Secondary | R0 Resection Rate | At curative-intent surgery, approximately 6-12 weeks after the first study dose | The proportion of participants undergoing curative-intent surgery who achieve microscopically negative surgical margins (R0 resection), as confirmed by histopathological examination. | ClinicalTrials.gov |
| Secondary | Organ Preservation Rate | From baseline surgical assessment to definitive surgery, approximately 6-12 weeks after the first study dose | Among participants assessed by a multidisciplinary team before study enrollment as requiring function-ablative surgery, the proportion who undergo organ-function-preserving surgery while achieving R0 resection after adaptive neoadjuvant treatment. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events (AEs) | From first study drug administration through the protocol-defined safety follow-up period (up to 48 months) | The incidence and severity of adverse events, serious adverse events, and immune-related adverse events, graded according to NCI CTCAE version 6.0. Treatment-related events, events leading to dose modification or discontinuation, and perioperative complications will also be assessed. | ClinicalTrials.gov |
| Secondary | Event-Free Survival (EFS) Rate at 1 and 2 Years | At 1 year and 2 years after the first study dose | The estimated proportion of participants remaining event-free at 1 year and 2 years after initiation of adaptive neoadjuvant therapy, calculated using the Kaplan-Meier method according to the protocol-defined event criteria. | ClinicalTrials.gov |
| Secondary | Disease-Free Survival (DFS) Rate at 1 and 2 Years | At 1 year and 2 years after curative-intent surgery | The estimated proportion of participants remaining disease-free at 1 year and 2 years following curative-intent surgery, calculated using the Kaplan-Meier method. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) Rate at 1 and 2 Years | At 1 year and 2 years after the first study dose | The estimated proportion of participants alive at 1 year and 2 years after initiation of adaptive neoadjuvant therapy, calculated using the Kaplan-Meier method. | ClinicalTrials.gov |
| Secondary | Clinicopathological Downstaging Rate | From baseline staging to postoperative pathological assessment, approximately 6-12 weeks after the first study dose | The proportion of participants whose postoperative pathological TNM stage (pTNM) is lower than the clinical TNM stage (cTNM) assessed after induction immunochemotherapy and before adaptive neoadjuvant treatment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)