Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

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List	Outcome	Time frame	Description
Primary	Response Rate in MEDI4736-treated Participants	Up to 3 years post registration	The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Primary	Overall Response Rate Among PD-L1 Positive Participants Treated With MEDI4736	Up to 3 years post registration	The percentage of PD-L1 positive participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary	Investigator-assessed Progression-free Survival in Participants Treated With MEDI4736	Up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions or an absolute increase of \>= 0.5cm, or a measurable increase in a non-target lesion, or the appearance of new lesions or death due to disease without prior documentation of progression or symptomatic deterioration.
Secondary	Investigator-assessed Progression-free Survival in PD-L1 Positive Participants Treated With MEDI4736	up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions or an absolute increase of \>= 0.5cm, or a measurable increase in a non-target lesion, or the appearance of new lesions or death due to disease without prior documentation of progression or symptomatic deterioration.
Secondary	Overall Survival in MEDI4736-treated Participants	Up to 3 years post-registration	Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
Secondary	Overall Survival in PD-L1 Positive MEDI4736-treated Participants	up to 3 years post registration	Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
Secondary	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Duration of treatment and follow up until death or 3 years post registration	Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Secondary	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy in Participants Treated With MEDI4736	up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause
Secondary	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy in PD-L1 Positive Participants Treated With MEDI4736	up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause
Secondary	Overall Survival	Up to 3 years post registration	Duration from date of sub-study registration (or date of screening/pre-screening registration if participant never enrolls in a sub-study) to date of death due to any cause. Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.
Secondary	Investigator-assessed Progression-free Survival	Up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause. Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.
Secondary	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy	Up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause.
Secondary	Response Rate	Up to 3 years post registration	The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 or docetaxel per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.
Other	Screen Success Rate	Up to 3 years	Will be monitored by the percentage of screened patients that register to a therapeutic sub-study.
Other	Treatment Arm Randomization Acceptance Rate	Up to 3 years	Will be monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to. (Design #1)

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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