Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCoordination Pharmaceuticals, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of head-neck cancer that requires palliative radiotherapy
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RiMO-301
Treatment groups
16 Participants
are divided into 1 treatment groupSponsors and collaborators
Coordination Pharmaceuticals, Inc.
Lead sponsor
University of Illinois at Chicago
Collaborator
Source ClinicalTrials.gov