Trial · NCT06757244
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) according to Response Evaluation Criteria version 1.1 (RECIST 1.1) in patients with pancreatic adenocarcinoma and measurable disease | 24 months | The proportion of patients with an objective response at the completion of their follow-up (truncated at 24 months), among all eligible patients. An objective response will be defined as the best overall response of complete response (CR) or partial response (PR) assessed by investigators using validated criteria (i.e. RECIST 1.1) |
| Secondary | Incidence of treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0. | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | The number and percentage of participants experiencing at least one treatment-emergent adverse event (TEAE) will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. TEAEs are defined as adverse events occurring after the initiation of study treatment and before 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, must be reported by the investigator, or an already present event that worsens in intensity or frequency following the treatment. TEAEs will be categorized by type (serious or non-serious; expected or unexpected) and severity (CTCAE grades 1 to 5) as per investigator assessment |
| Secondary | Incidence of participants with adverse events of special interest (AESIs) as assessed by CTCAE v5.0. | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | The number and percentage of participants experiencing at least one adverse events of special interest (AESIs) will be summarized. AESIs are pre-defined events requiring detailed monitoring and rapid communication by the investigator due to their potential association with the investigational product. The severity of AESIs will be graded using CTCAE v5.0 (CTCAE grades 1 to 5). |
| Secondary | Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry, Thyroid Function and Urinalysis Lab Parameters | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | Blood and urine samples will be collected to evaluate hematology, clinical chemistry, thyroid function and urinalysis lab parameters . Changes from baseline to post-baseline visits will be computed. Final values and changes from baseline in continuous variables will be described et each visit. Clinically significant laboratory abnormalities (as defined by CTCAE v5.0 criteria) will also be reported. |
| Secondary | Number of Participants With AEs Leading to Death | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | Number of participants with TEAEs leading to death will be assessed. |
| Secondary | Median Progression Free Survival (mPFS) in months | 24 months | The median PFS will be assessed as the time after which half of the patients are progression-free and alive. |
| Secondary | Median Overall Survival (mOS) in months | 24 months | The median OS will be assessed as the time after which half of the patients are alive. |
| Secondary | Median Duration of Response (mDOR) in months | 24 months | the time from onset of first response (PR or CR as defined above) to progression or death due to any reason, whichever occurs first |
| Secondary | Number of Participants With Immune Related Adverse Events (irAEs) | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | The irAEs are events which may be severe or fatal according to CTCAE v5.0 and can occur in participants treated with monoclonal antibodies directed against immune checkpoints, including dostarlimab While irAEs (eg, diarrhea/colitis, pneumonitis, nephritis, hypophysitis, adrenalitis, thyroiditis, severe skin reactions, uveitis, myocarditis, and hepatotoxicity) usually occur during treatment, symptoms can also manifest after discontinuation of treatment. |
| Secondary | Clinical benefit rate according to RECIST 1.1 (CBR) | 24 months | the proportion of patients with the Best Overall Response equal to Complete Response, Partial Response or Stable Disease, among all eligible patients. |
| Secondary | Number of Participants With Adverse Events Leading to Discontinuation | From the initiation of study treatment until 90 days after the last dose or 30 days following cessation of study intervention if the participant initiates new anticancer therapy, whichever is earlier, assessed up to 24 months" | An AE is any event that was not present prior to the initiation of study treatment or any eventalready present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with adverse events leading to discontinuation will be assessed. |
| Secondary | Incidence of patient premature discontinuations (due to SAE or non-adherence to protocol) | From the initiation of study treatment until premature discontinuation due to serious adverse event or non adherence to protocol whichever is earlier, assessed up to 24 months" | Incidence of serious adverse events or non adherence to protocol leading to discontinuation will be assessed. |
| Secondary | Incidence of dose modifications | From the initiation of study treatment until the last dose administration, assessed up to 24 months" | Incidence of dose modifications due to the appearance of AEs (measured in dose modification compared with the protocol planned dose of treatments) |
| Secondary | Incidence of delays or interruptions in the administration of treatment due to the appearance of AEs | From the initiation of study treatment until the last dose administration, assessed up to 24 months" | Incidence of delays or interruptions in the administration of treatment due to the appearance of AEs (measured in days or weeks since the initial scheduled date of treatment) |
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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