Ignite Creation Date:
2024-05-06 @ 12:54 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01683188
Status:
TERMINATED
Last Update Posted:
2021-02-01
First Post:
2012-09-07
Brief Title:
HD IL-2 Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma
Sponsor:
Clinigen Inc
Organization:
Clinigen Inc
Study Overview
Official Title:
A Multi-Center Study of High Dose Aldesleukin Interleukin-2 Vemurafenib Therapy in Patients With BRAFV600 Mutation Positive Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual led to early closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROCLIVITY01
Brief Summary:
This is a research study to evaluate treatment of metastatic melanoma patients with a combination of drugs The combination being studied is vemurafenib also known as Zelboraf and High Dose Interleukin-2 abbreviated as HD IL-2 and known as Proleukin The combination of vemurafenib and HD IL-2 immunotherapy may enhance the response
Detailed Description:
This will be an open-label uncontrolled two-arm multi-center study in patients with metastatic melanoma with BRAFV600 oncogene mutations Patients will initially receive treatment with vemurafenib interspersed with two courses of High Dose IL-2 HD IL-2 Patients are eligible for the study if they have melanoma positive for the BRAFV600 mutation have been on vemurafenib therapy for 0-18 weeks have responding or stable disease if on vemurafenib and meet the requirements for dosing with HD IL-2 and all protocol inclusion and exclusion criteria
Two Cohorts will be enrolled differing only in how they are characterized prior to HD IL-2 treatment
Cohort 1 will consist of 135 patients naïve to vemurafenib and HD IL-2 therapy Patients in Cohort 1 will have an initial evaluation and receive a defined 6 1 week course of vemurafenib before beginning HD IL-2 This Cohort will be used to define study size and statistical validity with the comparator being historic controls using data from the BRAF positive patients from the Melanoma SELECT study Protocol IIT10PLK06
Cohort 2 will consist of up to 50 patients who have been on vemurafenib therapy for 7 to 18 weeks with stable or responding disease before starting HD IL-2 Patients in Cohort 2 will have an initial evaluation and will begin HD IL-2 treatment after 7 to 18 weeks of treatment with vemurafenib This Cohort is designed to evaluate whether additive or synergistic clinical benefit or toxicity is observed in BRAFV600 mutation positive metastatic melanoma patients treated with vemurafenib as a single agent for 7 to18 weeks prior to the first course of HD IL-2 therapy in conjunction with continued vemurafenib
Patients in both cohorts will discontinue dosing vemurafenib prior to each treatment with HD IL-2 and resume dosing after each discharge Patients will receive up to two courses four cycles of HD IL-2 and will be evaluated for their disease responses at 10 weeks 3 weeks from the start of HD IL-2 dosing and 26 weeks 3 weeks from the start of HD IL-2 dosing QTc intervals will be reviewed daily for changes during each cycle of HD IL-2 dosing
Administration of vemurafenib and HD IL-2 will be according to the respective Package Inserts and according to the Institutions standard of care The investigator will determine the number of HD IL-2 cycles each patient will receive according to the investigators discretion and medical judgment
Two Cohorts will be enrolled differing only in how they are characterized prior to HD IL-2 treatment
Cohort 1 will consist of 135 patients naïve to vemurafenib and HD IL-2 therapy Patients in Cohort 1 will have an initial evaluation and receive a defined 6 1 week course of vemurafenib before beginning HD IL-2 This Cohort will be used to define study size and statistical validity with the comparator being historic controls using data from the BRAF positive patients from the Melanoma SELECT study Protocol IIT10PLK06
Cohort 2 will consist of up to 50 patients who have been on vemurafenib therapy for 7 to 18 weeks with stable or responding disease before starting HD IL-2 Patients in Cohort 2 will have an initial evaluation and will begin HD IL-2 treatment after 7 to 18 weeks of treatment with vemurafenib This Cohort is designed to evaluate whether additive or synergistic clinical benefit or toxicity is observed in BRAFV600 mutation positive metastatic melanoma patients treated with vemurafenib as a single agent for 7 to18 weeks prior to the first course of HD IL-2 therapy in conjunction with continued vemurafenib
Patients in both cohorts will discontinue dosing vemurafenib prior to each treatment with HD IL-2 and resume dosing after each discharge Patients will receive up to two courses four cycles of HD IL-2 and will be evaluated for their disease responses at 10 weeks 3 weeks from the start of HD IL-2 dosing and 26 weeks 3 weeks from the start of HD IL-2 dosing QTc intervals will be reviewed daily for changes during each cycle of HD IL-2 dosing
Administration of vemurafenib and HD IL-2 will be according to the respective Package Inserts and according to the Institutions standard of care The investigator will determine the number of HD IL-2 cycles each patient will receive according to the investigators discretion and medical judgment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None