Trial · NCT07898124
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1a | From first dose through 3 weeks after the last vaccine dose (7 weeks) | A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, except Grade 3 injection site reactions adequately controlled with medical treatment. Reported by dose level. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1a | Frame: From first dose through 30 days after the last vaccine dose (approximately 8 weeks) | TEAEs and SAEs graded by severity per NCI CTCAE v6.0, reported by dose level. |
| Primary | Recommended Phase 2 Dose (RP2D) of TMV Vaccine Alone | From first dose through 3 weeks after the last vaccine dose (7 weeks) | RP2D of TMV vaccine monotherapy, selected based on the totality of safety, tolerability, and immunogenicity data across Phase 1a dose levels. |
| Primary | Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months) | A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, in participants receiving TMV vaccine plus toripalimab-tpzi. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b | From first dose through 30 days after the last dose of study treatment (up to approximately 15 months) | TEAEs and SAEs graded by severity per NCI CTCAE v5.0. |
| Primary | Number of Participants With Immune-Related Adverse Events (irAEs) Attributable to Toripalimab-tpzi in Phase 1b | From first dose through 30 days after the last dose of study treatment (up to approximately 15 months) | Immune-related adverse events attributed to toripalimab-tpzi, graded by severity per NCI CTCAE v5.0. |
| Primary | Recommended Phase 2 Dose (RP2D) of TMV Vaccine Plus Toripalimab-tpzi | From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months) | RP2D of TMV vaccine in combination with toripalimab-tpzi, selected based on the totality of safety, tolerability, and immunogenicity data. |
| Secondary | Change From Baseline in T Cell Activation and Phenotype in Peripheral Blood | Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6) | Activation status and phenotype of T cell subsets in peripheral blood mononuclear cells (PBMCs), measured by flow cytometry, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b). |
| Secondary | Change From Baseline in Plasma Cytokine and Chemokine Levels | Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6) | Plasma cytokine and chemokine biomarkers measured in peripheral blood in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b). |
| Secondary | Change in Percentage of Viable Tumor Cells From Baseline Biopsy to Surgical Resection in Phase 1b | From pre-treatment biopsy to surgical resection (approximately 10 weeks) | Pathologic response to neoadjuvant TMV vaccine plus toripalimab-tpzi, measured as the change in viable tumor cell percentage from the pre-treatment biopsy to the resected specimen. |
| Secondary | Major Pathologic Response (MPR) Rate in Phase 1b | At surgical resection (approximately 10 weeks after biopsy) | Percentage of participants with 10% or fewer viable tumor cells in the resected specimen after neoadjuvant TMV vaccine plus toripalimab-tpzi. |
| Secondary | Pathologic Complete Response (pCR) Rate in Phase 1b | At surgical resection (approximately 10 weeks after biopsy) | Percentage of participants with no viable tumor cells (0%) in the resected specimen after neoadjuvant TMV vaccine plus toripalimab-tpzi. |
| Secondary | Objective Response Rate (ORR) per RECIST v1.1 in Phase 1b | At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose) | Percentage of participants with a complete or partial response per RECIST v1.1 on the restaging scan before surgery. |
| Secondary | Disease Control Rate (DCR) per RECIST v1.1 in Phase 1b | At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose) | Percentage of participants with a complete response, partial response, or stable disease per RECIST v1.1 on the restaging scan before surgery. |
| Secondary | Progression-Free Survival (PFS) | Up to 3 years | Time from treatment initiation to first documented disease recurrence or death from any cause, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b). |
| Secondary | Overall Survival (OS) | Up to 3 years | Time from treatment initiation to death from any cause, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b). |
| Other | Correlation Between Tumor PD-L1 Combined Positive Score (CPS) and Immune Stimulating Activity | From baseline through end of treatment (up to approximately 15 months) | Tumor PD-L1 expression measured as combined positive score (CPS) by immunohistochemistry (22C3) on paraffin-embedded tumor sections. Correlation (Spearman coefficient) with each immune stimulating activity measure, reported separately: (1) neoantigen-specific T cell response in PBMCs (spot-forming units per 10\^6 PBMCs by IFN-γ ELISpot) and (2) change in CD8+ tumor-infiltrating lymphocyte density (cells/mm² by IHC), in participants receiving TMV vaccine alone or with toripalimab-tpzi. |
| Other | Correlation Between Baseline CD8+ Tumor-Infiltrating Lymphocyte (TIL) Density and Immune Stimulating Activity | From baseline through end of treatment (up to approximately 15 months) | CD8+ TIL density (cells/mm²) determined by immunohistochemistry on paraffin-embedded tumor sections. Correlation (Spearman coefficient) with neoantigen-specific T cell response, in participants receiving TMV vaccine alone or with toripalimab-tpzi. |
| Other | Correlation of Tumor Cellularity With TMV Vaccine Yield | At tumor tissue collection and vaccine production (baseline) | Tumor cellularity determined by histological scoring, correlated with the total yield of TMV vaccine produced from the tumor tissue, along with immunogenicity and clinical response. |
| Other | Tumor Mutational Burden (TMB) | Baseline (tumor tissue collected at salvage surgery in Phase 1a or at pre-treatment biopsy in Phase 1b, with matched PBMCs) | TMB (mutations per megabase) by next-generation sequencing (NGS) of DNA from tumor tissue, with matched PBMC samples as germline reference. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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