RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer

Quick Facts

Study Start:2023-04-03

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05838729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ze-Qi Xu

CONTACT

630-415-5601

zq@coordinationpharma.com

Principal Investigator

Lawrence Feldman, MD

PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Study Locations (Sites)

University of Illinois at Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Coordination Pharmaceuticals, Inc.

Lawrence Feldman, MD, PRINCIPAL_INVESTIGATOR, University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-03

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-04-03

Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

Head Neck Cancer
Intratumoral Injection