Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Primary Objectives:
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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
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To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab)
Secondary Objectives:
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To evaluate progression-free survival for up to 12 months
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To determine overall survival for up to 24 months
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RiMO-301 Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation |
Drug: RiMO-301
Drug: RiMO-301 - A single dose of RiMO-301 will be administered via an intratumoral injection
Drug: Pembrolizumab or Nivolumab - PD-1 inhibitor (pembrolizumab or nivolumab) will be administered via a 30-minute intravenous infusion until disease progression or unacceptable toxicity
Radiation: Radiotherapy - Patients will receive hypofractionated radiation in 5 fractions
Other Names:
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Outcome Measures
Primary Outcome Measures
- Determination of Recommended Dose [6 weeks]
• 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
- Evaluation of Anti-Tumor Response [12 months]
• To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST
Secondary Outcome Measures
- Evaluation of Progression-Free Survival [12 months]
Time from enrollment to local-regional recurrence, local-regional progression, distant progression or death from any cause, whichever occurs first
- Evaluation of Overall Survival [24 months]
Time from enrollment to death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of head-neck cancer that requires palliative radiotherapy
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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:
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receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or
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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
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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
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The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable
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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
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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
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Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment
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Have adequate bone marrow reserve and adequate liver function
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Have a life expectancy of at least 12 weeks
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ECOG score of 0-2
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Age 18 years or older
Exclusion Criteria:
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Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
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Symptomatic central nervous system metastases and/or carcinomatous meningitis
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Active autoimmune disease that has required systemic treatment in the past 2 years
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Ongoing clinically significant infection at or near the incident lesion
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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
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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
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Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- Coordination Pharmaceuticals, Inc.
- University of Illinois at Chicago
Investigators
- Principal Investigator: Lawrence Feldman, MD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RiMO-HNC-IO1