Trial record 1 of 1 for:
D4191C00068 - STRONG
An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies. (STRONG)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03084471 |
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Recruitment Status :
Active, not recruiting
First Posted : March 21, 2017
Results First Posted : June 15, 2021
Last Update Posted : May 25, 2022
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Advanced Solid Malignancies |
| Interventions |
Biological: MEDI4736 (Durvalumab) Biological: MEDI4736 (Durvalumab) + Tremelimumab |
| Enrollment | 867 |
Participant Flow
| Recruitment Details | Participants who met all the inclusion and none of the exclusion criteria were randomized at 77 study centers across 8 countries (Canada, France, Germany, Italy, Republic of Korea, Netherlands, United Kingdom and United States of America). |
| Pre-assignment Details | During the screening period (4 weeks), eligible participants signed the informed consent. All the study assessments were performed as per the schedule of assessment. |
| Arm/Group Title | Durvalumab |
|---|---|
 Arm/Group Description |
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity. |
| Period Title: Overall Study | |
| Started | 867 |
| Completed | 0 |
| Not Completed | 867 |
| Reason Not Completed | |
| Development of study specific discontinuation criteria | 2 |
| Condition under investigation worsened | 84 |
| Lack of therapeutic response | 2 |
| Protocol Violation | 1 |
| Adverse Event | 73 |
| Withdrawal by Subject | 12 |
| Disease relapse | 181 |
| Subjective disease progression | 359 |
| Other (as recorded) | 33 |
| Patients who were still on study treatment at Data Cutoff | 120 |
Baseline Characteristics
| Arm/Group Title | Durvalumab | |
|---|---|---|
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Arm/Group Description |
All participants received fixed-dose of durvalumab 1500 mg every 4 weeks until disease progression or unacceptable toxicity. | |
| Overall Number of Baseline Participants | 867 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 867 participants | |
| 67.5 (9.36) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 867 participants | |
| Female |
173 20.0%
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| Male |
694 80.0%
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 603 participants | |
| American Indian or Alaska Native |
0 0.0%
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| Asian |
65 10.8%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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| Black or African American |
2 0.3%
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| White |
508 84.2%
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| More than one race |
0 0.0%
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| Unknown or Not Reported |
28 4.6%
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[1]
Measure Analysis Population Description: Race was not a mandatory variable to be collected in some sites due to data privacy reasons. Hence, the total number of participants analysed for race is lesser than Overall (Safety Analysis Set)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Disclosure of study information is prohibited without providing advance notice to AstraZeneca and opportunity to object.
Results Point of Contact
| Name/Title: | Global Clinical Lead |
| Organization: | AstraZeneca Clinical study Information Center |
| Phone: | 1-877-240-9479 |
| EMail: | information.center@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT03084471 |
| Other Study ID Numbers: |
D4191C00068 |
| First Submitted: | March 7, 2017 |
| First Posted: | March 21, 2017 |
| Results First Submitted: | March 22, 2021 |
| Results First Posted: | June 15, 2021 |
| Last Update Posted: | May 25, 2022 |