IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
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|ClinicalTrials.gov Identifier: NCT04562129|
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : November 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Stage III Melanoma Stage IV Inoperable Disease||Drug: Interleukin-2 Drug: Ipilimumab Drug: Nivolumab||Phase 2|
This is a Phase II study of high dose bolus interleukin-2 (HD IL2) in combination with low dose ipilimumab followed sequentially by nivolumab in patients with advanced inoperable stage III or stage IV melanoma who have failed prior anti-PD1 immunotherapy.
The planned treatment consists of up to 3 courses (One cycle is 21 days and one course is 4 cycles). HD IL2 will be given during week 1 of the 2 initial cycles or each course. Ipilimumab will be given concurrently at the low dose of 1 mg/kg on Day 1 of the 2 initial cycles of each course for up to 2 doses, total. Nivolumab will be given on Day 1 of the 3rd cycle of each course. No systemic treatment will be administered during the 4th cycle. Response assessment will occur at the end of the 4th cycle. Patients without evidence of disease progression (RECIST v.1.1) or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses, total
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of High Dose Bolus IL2 in Combination With Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy|
|Actual Study Start Date :||September 24, 2020|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2029|
HD IL2 (600,000 units/kg/dose IV) will be given during week 1 of the 2 initial cycles or each course. Ipilimumab will be given concurrently at the low dose of 1 mg/kg during week one of the 2 initial cycles of each course for up to 2 doses, total. Nivolumab will be given on during week one of the 3rd cycle of each course. No systemic treatment will be administered during the 4th cycle. Patients without evidence of disease progression (RECIST v.1.1) or limiting toxicities will be offered additional courses of treatment for up to a maximum of 3 courses, total.
High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)
Other Name: Aldesleukin
Low dose Ipilimumab given at time of HD IL2 administration on day 1 of the first 2 cycles of each course.
Nivolumab will be given at a dose of 480 mg IV week 7 of each course.
- Response Rate [ Time Frame: Up to 9 months ]Response rate (Complete Response + Partial Response) of HD IL2 plus low dose ipilimumab followed sequentially by nivolumab in patients with inoperable stage III or stage IV melanoma who have either failed prior treatment with anti-PD1 immunotherapy (nivolumab or pembrolizumab) or have demonstrated tumor progression following such therapy.
- Progression Free Survival [ Time Frame: Up to 5 years ]Progression Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression (or death if there is no progression date). Patients with neither a progression date nor date of death will be censored as of last contact.
- Overall Survival [ Time Frame: Up to 5 years ]Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death.
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): NCT04562129
|Contact: Lori McCormick||813-745-4858||Lori.McCormick@moffitt.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Lori McCormick 813-745-4858 Lori.McCormick@moffitt.org|
|Principal Investigator: Ahmad Tarhini, MD, PhD|
|Sub-Investigator: Andrew Brohl, MD|
|Sub-Investigator: Zeynep Eroglu, MD|
|Sub-Investigator: Nikhil Khushalani, MD|
|Sub-Investigator: Joseph Markowitz, MD, PhD|
|Principal Investigator:||Ahmad Tarhini, MD, PhD||Moffitt Cancer Center|