Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma
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|ClinicalTrials.gov Identifier: NCT01496807|
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Sylatron Drug: Yervoy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma|
|Study Start Date :||February 17, 2012|
|Actual Primary Completion Date :||March 16, 2016|
|Actual Study Completion Date :||August 29, 2016|
Experimental: Yervoy with Sylatron
Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
Sylatron - Once per week for 12 weeks, given as an injection under the skin.
Other Name: PEG-Intron
Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).
Other Name: Ipilimumab
- Maximum Tolerated Dose (MTD) of Sylatron [ Time Frame: Up to 48 Months ]MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).
- Maximum Tolerated Dose (MTD) of Ipilimumab [ Time Frame: Up to 48 Months ]MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.
- Number of Participants With Overall Response (OR) [ Time Frame: Up to 54 Months ]Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden >50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.
- Progression Free Survival (PFS) [ Time Frame: Up to 54 Months ]Immune Related Progressive Disease (irPD): increase in tumor burden >25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.
- Overall Survival (OS) [ Time Frame: Up to 54 Months ]OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
- Treatment Related Adverse Events (AEs) - Grade 3 to 5 [ Time Frame: 4 Years, 1 Month ]Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.
- Count of Participants Developing Positive Autoantibody Screen [ Time Frame: Up to 54 Months ]
Number of participants who developed a positive result during treatment for one or more antibodies of a previously negative screen.
This study was not designed to statistically test the efficacy of treatment, and no inferential analyses will be performed. Investigators planned to look for evidence of serologic and clinical autoimmunity.
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): NCT01496807
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Andrew Brohl, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|