Trial · NCT06097728
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in experimental arm relative to comparator arm | up to approximately 61 months | OS is defined as the time from randomization until the date of death due to any cause. |
| Secondary | Overall Survival (OS) | up to approximately 61 months | OS is defined as the time from randomization until the date of death due to any cause. |
| Secondary | Progression Free Survival (PFS) | up to approximately 61 months | PFS is defined as the time from randomization until progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site, or death due to any cause. |
| Secondary | Landmark OS | 12, 18, 24, 36 months | Landmarks of OS12, OS18, OS24, and OS36. |
| Secondary | Landmark PFS | 6, 12, 18, 24 months | Landmarks of PFS6, PFS12, PFS18, and PFS24 |
| Secondary | Overall Response Rate (ORR) | up to approximately 61 months | Proportion of participants who have a confirmed Complete Response or confirmed Partial Response, as determined by the investigator at local site per mRECIST 1.1 and/or RECIST 1.1. |
| Secondary | Duration of Response (DoR) | up to approximately 61 months | DoR defined as the time from the date of first documented response until date of documented progression per mRECIST 1.1 and/or RECIST 1.1 as assessed by the investigator at local site or death due to any cause. |
| Secondary | PFS2 | up to approximately 61 months | PFS2 defined as the time from randomization to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death. |
| Secondary | Patient-reported physical functioning | up to approximately 61 months. | TTD in physical functioning as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Short Form 8c. There are 8 questions each from a scale of 1 (unable to do) to a scale of 5 (With a little difficulty). The higher the scores the better the patient-reported physical functioning is. |
| Secondary | Disease-related symptoms using EORTC IL305 (Q1) | Up to approximately 61 months. | Change from baseline in disease-related symptoms as measured by individual symptom items from the EORTC (European Organisation For Research And Treatment Of Cancer) IL305 (Item Library 305) (Q1). It is scored from a 1 (not at all) to a 4 (very much). The higher the score the higher the disease-related symptoms. |
| Secondary | Disease-related symptoms using PRO-CTCAE (Q1, 5, 6, 9) | Up to approximately 61 months | Change from baseline in disease-related symptoms as measured by individual symptom items from the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) (Q1, 5, 6, 9). PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present). The higher the score the higher the disease-related symptoms. |
| Secondary | Patient-reported role functioning using EORTC QLQ-C30 RF subscale (IL305 Q2 3) | up to approximately 61 months | Change from baseline in functioning will be assessed by the following measure: Role functioning: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 RF (Role Functioning) subscale (IL305 Q2 3) (Item Library 305). The questions are from a scale of 1 (not at all) to 4 (very much). The lower the score the higher the patient-reported role functioning is. |
| Secondary | Patient-reported HRQoL (Health-related Quality of Life) using EORTC QLQ-C30 HRQoL subscale (IL305 Q7-8) | Up to approximately 61 months | Change from baseline in functioning will be assessed by the following measure: HRQoL: EORTC (European Organisation For Research And Treatment Of Cancer) QLQ (Quality of Life Questionnaire) -C30 HRQoL subscale (IL305 Q7-8) (Item Library 305). The questions are from a scale of 1 (very poor) to 7 (excellent). The higher the score the higher the HRQoL. |
| Secondary | Immunogenicity of volrustomig | up to approximately 61 months | Incidence of Anti-Drug Antibodies against volrustomig. |
| Secondary | Incidence of Adverse Events (AEs) AEs graded by CTCAE version 5.0 | Up to approximately 61 months | Incidence of Adverse Events (AEs) AEs graded by CTCAE (Common Terminology Criteria for Adverse Events) version 5.0. Grade refers to the severity of the AE. The CTCAE displays grade 1 (mild) through 5 (death related to AE). Grade 2 (moderate), Grade 3 (Severe) and Grade 4 (Life-threatening consequences). |
| Secondary | Area under the curve (AUC) | Up to approximately 61 months | The concentration of MEDI5752 in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
| Secondary | Maximum plasma concentration of the drug (Cmax) | Up to approximately 61 months | The concentration of MEDI5752 in serum will be determined (Cmax will be derived). |
| Secondary | The time taken to reach the maximum concentration (Tmax) | Up to approximately 61 months | The concentration of MEDI5752 in serum will be determined (Tmax will be derived). |
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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