Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma
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ClinicalTrials.gov Identifier: NCT02743819 |
Recruitment Status :
Active, not recruiting
First Posted : April 19, 2016
Results First Posted : April 21, 2022
Last Update Posted : April 21, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | April 14, 2016 | ||||
First Posted Date ICMJE | April 19, 2016 | ||||
Results First Submitted Date ICMJE | December 23, 2021 | ||||
Results First Posted Date ICMJE | April 21, 2022 | ||||
Last Update Posted Date | April 21, 2022 | ||||
Actual Study Start Date ICMJE | June 28, 2016 | ||||
Actual Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Response Rate (OR) Per irRECIST [ Time Frame: 16 weeks ] Per Response Evaluation Criteria for use in trials testing immunotherapeutics (iRECIST) for target lesions and assessed by CT or 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
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Original Primary Outcome Measures ICMJE |
Response rate per irRECIST [ Time Frame: 16 weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Pembrolizumab and Ipilimumab After Prior Immunotherapy for Melanoma | ||||
Official Title ICMJE | Phase II Study of Pembrolizumab and Ipilimumab Following Initial Anti-PD1/L1 Antibody | ||||
Brief Summary | Phase II study evaluating the benefit of the combination of anti-PD1 (pembrolizumab) and anti-CTLA4 (ipilimumab) antibodies in advanced melanoma. The study will determine the response rate of the combination and evaluate other clinical parameters such as progression-free survival and safety of the combination following anti-PD1/L1 antibody. The study will also provide the opportunity to investigate blood or tumor based factors that may predict response to anti-PD1 antibody in combination with anti-CTLA4. | ||||
Detailed Description | Primary Objective: To determine the irRECIST* response rate of pembrolizumab with ipilimumab following initial progression or stable disease to anti-PD1/L1 antibody (or combination not containing anti-CTLA4) in subjects with advanced melanoma. Secondary Objective
Exploratory Objective: To evaluate changes in the tumor microenvironment and other biospecimens before and after adding ipilimumab to pembrolizumab. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment
Treatment with the combination of pembrolizumab and ipilimumab.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
70 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2022 | ||||
Actual Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: In order to be eligible for participation in this trial, the subject must:
Exclusion Criteria: The subject must be excluded from participating in the trial if the subject:
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines are live attenuated vaccines, and are not allowed. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02743819 | ||||
Other Study ID Numbers ICMJE | IRB17-0686 IRB15-1788 ( Other Identifier: University of Chicago ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | University of Chicago | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Chicago | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Chicago | ||||
Verification Date | April 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |