Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838729
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-04-13
Brief Title:
Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
Sponsor:
Coordination Pharmaceuticals Inc
Organization:
Coordination Pharmaceuticals Inc
Study Overview
Official Title:
Phase 1b2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable Recurrent or Metastatic Head-Neck Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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:
This is a prospective open-label single arm non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable recurrent or metastatic head-neck cancer
Detailed Description:
Primary Objectives
To determine the tolerability of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor pembrolizumab or nivolumab in patients with unresectable recurrent or metastatic head-neck cancer
To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor pembrolizumab or nivolumab
Secondary Objectives
To evaluate progression-free survival for up to 12 months
To determine overall survival for up to 24 months
To assess patient quality of life
The target population is patients with unresectable recurrent or metastatic head-neck cancer which is clinically accessible to intratumoral injection
To determine the tolerability of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor pembrolizumab or nivolumab in patients with unresectable recurrent or metastatic head-neck cancer
To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor pembrolizumab or nivolumab
Secondary Objectives
To evaluate progression-free survival for up to 12 months
To determine overall survival for up to 24 months
To assess patient quality of life
The target population is patients with unresectable recurrent or metastatic head-neck cancer which is clinically accessible to intratumoral injection
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