Viewing Study NCT05739981



Ignite Creation Date: 2024-05-06 @ 6:39 PM
Last Modification Date: 2024-10-26 @ 2:52 PM
Study NCT ID: NCT05739981
Status: RECRUITING
Last Update Posted: 2024-06-07
First Post: 2023-02-13

Brief Title: Phase II IMNN-001 Also Known as GEN-1 on SLL With BEV and NACT Newly Diagnosed Advanced Ovarian Fallopian Tube or Primary Peritoneal Cancer
Sponsor: Imunon
Organization: Imunon

Study Overview

Official Title: Phase II Study Evaluating the Effect of IMNN-001 on Second Look Laparoscopy SLL in Combination With Bevacizumab BEV and Neoadjuvant Chemotherapy NACT in Newly Diagnosed With Advanced Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status: 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: MRD
Brief Summary: This is a 11 randomized open label multi-center phase III trial to evaluate the safety dosing efficacy and biological activity of adding IMNN-001 to chemotherapy BEV compared to chemotherapy BEV alone
Detailed Description: This is a 11 randomized open label multi-center phase III trial to evaluate the safety dosing efficacy and biological activity of adding IMNN-001 to chemotherapy BEV compared to chemotherapy BEV alone The chemotherapy NACT amp adjuvant will be a standard regimen of carboplatin paclitaxel administered every three weeks for a total of 7-9 cycles The protocol requires at least 4 cycles of NACT and allows up to 2 additional cycles of neoadjuvant therapy at the Investigators discretion based on response and other clinical considerations ICS will take place 3-4 weeks from last dose of NACT Following at least a 4-week recovery from ICS 3 additional adjuvant cycles of study treatments will be administered The minimum time interval between surgery and BEV administration will be 4 weeks for safety BEV will be included at Cycles 2 3 6 and 7 BEV may be substituted by an FDA approved biosimilar The experimental arm will add IMNN-001 weekly to each cycle of chemotherapy BEV beginning with Cycle 1 Day 15 and continue weekly through the last cycle of adjuvant therapy

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