Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-04-03
Brief Title:
A Study Comparing 3 Study Medicines Encorafenib Binimetinib Pembrolizumab to 2 Study Medicines Ipilimumab and Nivolumab in Patients With Advanced Melanoma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 2 RANDOMIZED OPEN-LABEL STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS NIVOLUMAB AND IPILIMUMAB IN PARTICIPANTS WITH BRAF V600EK MUTATION-POSITIVE MELANOMA WHO PROGRESSED DURING OR AFTER PRIOR TREATMENT WITH ANTI-PD-1 THERAPY
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PORTSIDE
Brief Summary:
The purpose of this study is to learn about the effects of 3 study medicines encorafenib binimetinib pembrolizumab compared to 2 study medicines ipilimumab and nivolumab given for the treatment of melanoma
Melanoma is a type of cancer that starts in the cells that give color to your skin
The study is seeking participants who
have advanced or metastatic melanoma has spread to other parts of the body
have a certain abnormal gene called BRAF
have taken nivolumab or pembrolizumab treatment before this study
Participants will either receive
pembrolizumab given by intravenous infusion directly into a vein every 3 weeks at the study clinic Participants will also receive encorafenib and binimetinib by mouth every day at home
or will receive ipilimumab and nivolumab given by intravenous infusion directly into a vein every 3 weeks at the study clinic 4 times This will be followed by nivolumab given by intravenous infusion every 4 weeks at the study clinic
Both pembrolizumab and nivolumab will be given for a maximum of around 2 years However there is no time limit for encorafenib and binimetinib treatment
The study team will see how each participant is doing after receiving the study treatments during regular visits to the study clinic
Melanoma is a type of cancer that starts in the cells that give color to your skin
The study is seeking participants who
have advanced or metastatic melanoma has spread to other parts of the body
have a certain abnormal gene called BRAF
have taken nivolumab or pembrolizumab treatment before this study
Participants will either receive
pembrolizumab given by intravenous infusion directly into a vein every 3 weeks at the study clinic Participants will also receive encorafenib and binimetinib by mouth every day at home
or will receive ipilimumab and nivolumab given by intravenous infusion directly into a vein every 3 weeks at the study clinic 4 times This will be followed by nivolumab given by intravenous infusion every 4 weeks at the study clinic
Both pembrolizumab and nivolumab will be given for a maximum of around 2 years However there is no time limit for encorafenib and binimetinib treatment
The study team will see how each participant is doing after receiving the study treatments during regular visits to the study clinic
Detailed Description:
The purpose of the study is to compare the efficacy of a triplet therapy encorafenib binimetinib pembrolizumab versus a doubletcontrol therapy nivolumab and ipilimumab Participants will have metastatic or unresectable locally advanced BRAF V600EK-mutant melanoma which progressed during or after prior treatment in the adjuvant or first-line metastatic setting with an approved anti-PD-1 monotherapy pembrolizumab or nivolumab
Approximately 150 participants will be randomized in a 11 ratio to the triplet or the doubletcontrol therapy 75 participants in each arm Randomization will be stratified by baseline serum LDH level and by type of PD-1 resistance
Approximately 150 participants will be randomized in a 11 ratio to the triplet or the doubletcontrol therapy 75 participants in each arm Randomization will be stratified by baseline serum LDH level and by type of PD-1 resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK-3475-C92 | OTHER | Merck Sharp Dohme LLC | None |
| 2021-003640-24 | EUDRACT_NUMBER | None | None |
| KEYNOTE-C92 | OTHER | None | None |