Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03761914
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-02-21
First Post:
2018-11-28
Brief Title:
Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers
Sponsor:
Sellas Life Sciences Group
Organization:
Sellas Life Sciences Group
Study Overview
Official Title:
A Phase 12 Study of Galinpepimut-S in Combination With Pembrolizumab MK 3475 in Patients With Selected Advanced Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-02
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:
None
Brief Summary:
To evaluate the safety and tolerability of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers Patients will be followed long-term for Overall Survival OS and safety The study will enroll approximately 90 patients and maximum study treatment duration is approximately 213 years
Detailed Description:
This is a Phase 12 open-label non-comparative multicenter multi-arm study of the Wilms Tumor-1 WT1-targeting multivalent heteroclitic peptide immunotherapeutic vaccine galinpepimut-S in combination with the programmed death-1 PD1 inhibitor pembrolizumab in patients with selected advanced cancers This study will assess the efficacy and safety of galinpepimut-S and pembrolizumab and investigate the effect of galinpepimut-S and pembrolizumab on various tumor types Patients will be followed long-term for OS and safety The study will enroll approximately 90 patients at up to 20 centers in the United States
Indications treated are colorectal third or fourth line ovarian second or third line small cell lung cancer second line breast cancer triple negative second line acute myelogenous leukemia unable to attain deeper morphological response than partial PR on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant
The first 2 galinpepimut-S injections will initially be administered as monotherapy every 3 weeks Week 0 and Week 3 Thereafter galinpepimut-S will be co-administered with pembrolizumab every 3 weeks for 4 additional administrations for the galinpepimut-S initial immunization induction phase series weeks 6-15 to coincide with the per label pembrolizumab dosing frequency After that there will be one un-paired administration of pembrolizumab week 18 and then galinpepimut-S will be resumed on an every 3-week schedule for 6 additional doses early immune booster phase weeks 21-36 At the end of this phase there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur weeks 39-45 and then galinpepimut-S will be resumed on an every 12-week schedule for 4 additional doses late immune booster phase weeks 48-84 After 84 weeks continuing non-progressed patients will be treated with pembrolizumab alone up until week 111
Pembrolizumab will be administered at a dose of 200 mg intravenously every 3 weeks on Day 1 of each cycle 3 week cycles starting on Study Week 6 and continuing for up to 2 years thereafter Study Week 111 Galinpepimut-S will be administered 30-60 minutes after the completion of IV infusion of pembrolizumab on Day 1 of each cycle during which the 2 drugs are being co-administered
Indications treated are colorectal third or fourth line ovarian second or third line small cell lung cancer second line breast cancer triple negative second line acute myelogenous leukemia unable to attain deeper morphological response than partial PR on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant
The first 2 galinpepimut-S injections will initially be administered as monotherapy every 3 weeks Week 0 and Week 3 Thereafter galinpepimut-S will be co-administered with pembrolizumab every 3 weeks for 4 additional administrations for the galinpepimut-S initial immunization induction phase series weeks 6-15 to coincide with the per label pembrolizumab dosing frequency After that there will be one un-paired administration of pembrolizumab week 18 and then galinpepimut-S will be resumed on an every 3-week schedule for 6 additional doses early immune booster phase weeks 21-36 At the end of this phase there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur weeks 39-45 and then galinpepimut-S will be resumed on an every 12-week schedule for 4 additional doses late immune booster phase weeks 48-84 After 84 weeks continuing non-progressed patients will be treated with pembrolizumab alone up until week 111
Pembrolizumab will be administered at a dose of 200 mg intravenously every 3 weeks on Day 1 of each cycle 3 week cycles starting on Study Week 6 and continuing for up to 2 years thereafter Study Week 111 Galinpepimut-S will be administered 30-60 minutes after the completion of IV infusion of pembrolizumab on Day 1 of each cycle during which the 2 drugs are being co-administered
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