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

ConditionsHead Neck CancerIntratumoral Injection
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • RiMO-301

    Drug

    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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: RiMO-301Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determination of Recommended Dose

• The dose limiting toxicities of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor, as assessed by CTCAEv5, will not be observed in 33% or more patients

Time frame
6 weeks
2

Evaluation of Anti-Tumor Response

• To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST

Time frame
12 months

Secondary outcomes

1

Evaluation of Progression-Free Survival

Time from enrollment to local-regional recurrence, local-regional progression, distant progression or death from any cause, whichever occurs first

Time frame
12 months
2

Evaluation of Overall Survival

Time from enrollment to death from any cause

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coordination Pharmaceuticals, Inc.

Lead sponsor

University of Illinois at Chicago

Collaborator

Source ClinicalTrials.gov
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