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
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Pembrolizumab Drug: Ipilimumab||Phase 2|
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.
- To summarize the progression-free survival (RECIST v1.1 and irRC) of the combination following prior treatment with anti-PD1/L1 antibody.
- To assess the safety of the combination following prior treatment with anti-PD1/L1 antibody.
To evaluate changes in the tumor microenvironment and other biospecimens before and after adding ipilimumab to pembrolizumab.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab and Ipilimumab Following Initial Anti-PD1/L1 Antibody|
|Actual Study Start Date :||June 28, 2016|
|Actual Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||June 2022|
Treatment with the combination of pembrolizumab and ipilimumab.
Pembrolizumab given every 3 weeks (200 mg) by IV infusion.
Other Name: Keytruda
Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
Other Name: Yervoy
- 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
- Progression Free Survival Using the Kaplan Meier Method [ Time Frame: 24 months ]Time to disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Participants With Adverse Events [ Time Frame: 30 days after the end of treatment ]Any treatment-related adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743819
|United States, Alabama|
|University of South Alabama|
|Mobile, Alabama, United States, 36604|
|United States, Florida|
|Mount Sinai Medical Center of Florida|
|Miami Beach, Florida, United States, 33140|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|
|Oncology Specialists S.C.|
|Park Ridge, Illinois, United States, 60068|
|Illinois Cancer Care|
|Peoria, Illinois, United States, 61615|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46804|
|United States, Virginia|
|Virginia Commonwealth University/ Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Thomas Gajewski, M.D.||University of Chicago|