Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer

Trial Title: Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer

NCT ID: NCT05838729

Condition: Head Neck Cancer
Intratumoral Injection

Conditions: Official terms:
Head and Neck Neoplasms

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: RiMO-301
Description: A single dose of RiMO-301 will be administered via an intratumoral injection. PD-1 inhibitor (pembrolizumab or nivolumab) will be administered via a 30-minute intravenous infusion until disease progression or unacceptable toxicity. Patients will receive hypofractionated radiation in 5 fractions.
Arm group label: RiMO-301

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Diagnosis of head-neck cancer that requires palliative radiotherapy - Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line: - receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or - suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator - Must have at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol - The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable - Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course - RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3 - Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment - Have adequate bone marrow reserve and adequate liver function - Have a life expectancy of at least 12 weeks - ECOG score of 0-2 - Age 18 years or older Exclusion Criteria: - Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions - Symptomatic central nervous system metastases and/or carcinomatous meningitis - Active autoimmune disease that has required systemic treatment in the past 2 years - Ongoing clinically significant infection at or near the incident lesion - Major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube and catheter placement - Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to RiMO-301 injection - Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Illinois at Chicago

Address:
City: Chicago
Zip: 60612
Country: United States

Status: Recruiting

Contact:
Last name: Michelle Karan

Phone: 312-996-9913
Email: makaran2@uic.edu

Start date: April 3, 2023

Completion date: December 1, 2026

Lead sponsor:
Agency: Coordination Pharmaceuticals, Inc.
Agency class: Industry

Collaborator:
Agency: University of Illinois at Chicago
Agency class: Other

Source: Coordination Pharmaceuticals, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05838729