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Virus Therapy
RiMO-301 + Radiotherapy for Head and Neck Cancer
Phase 1 & 2
Recruiting
Led By Lawrence Feldman, MD
Research Sponsored by Coordination Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial studies a new treatment for advanced head-neck cancer using radiation, a drug, and a PD-1 inhibitor.
Who is the study for?
This trial is for adults with head-neck cancer that's inoperable, recurrent, or has spread. They should have a lesion suitable for RiMO-301 injection and radiation therapy, not previously treated by radiation or at least six months post-radiation without complications. Participants need to be recovering from prior treatments' effects, have good organ function, an expected lifespan of 12+ weeks, and can be on standard PD-1 inhibitors like pembrolizumab or nivolumab.Check my eligibility
What is being tested?
The study tests RiMO-301 combined with hypofractionated radiotherapy and a PD-1 inhibitor (pembrolizumab/nivolumab) in patients with advanced head-neck cancer. It's an open-label (everyone knows the treatment), single-arm (one treatment group), non-randomized trial focusing on those who may benefit from palliative radiotherapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to immunotherapy such as fatigue, skin reactions at the injection site, flu-like symptoms including fever and chills, potential organ inflammation due to immune response activation by PD-1 inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of Recommended Dose
Evaluation of Anti-Tumor Response
Secondary outcome measures
Evaluation of Overall Survival
Evaluation of Progression-Free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: RiMO-301Experimental Treatment1 Intervention
Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation
Find a Location
Who is running the clinical trial?
Coordination Pharmaceuticals, Inc.Lead Sponsor
5 Previous Clinical Trials
112 Total Patients Enrolled
University of Illinois at ChicagoOTHER
609 Previous Clinical Trials
1,559,293 Total Patients Enrolled
Lawrence Feldman, MDPrincipal InvestigatorUniversity of Illinois at Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow and liver are functioning well.I am able to get out of my bed or chair and move around.I have symptoms from cancer spread to my brain or its coverings.I do not have severe chronic illnesses or conditions affecting my organs.I have recovered from the side effects of my previous cancer treatments.I have a serious infection at or near my cancer site.I can have RiMO-301 injections as long as my total tumor volume is under 250 cm3.I have head or neck cancer and need radiotherapy to ease symptoms.I have head and neck cancer that cannot be removed by surgery and qualifies for PD-1 inhibitor treatment.I have a tumor that can be reached for treatment with an injection.My cancer can be measured and is not in an area treated with radiation before.I am 18 years old or older.I have not needed treatment for an autoimmune disease in the last 2 years.My cancer affects major blood vessels or structures.I have had recent surgery in the area affected by my condition.I haven't taken cancer drugs other than PD-1 inhibitors in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: RiMO-301
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any enrolment opportunities for this research endeavor?
"This clinical trial is actively seeking participants, which was initially advertised on April 3rd 2023 and has had a most recent update as of April 28th 2023."
Answered by AI
What is the maximum number of participants for this investigation?
"Yes, clinicaltrials.gov displays that this clinical trial is actively recruiting participants. It was initially posted on April 3rd 2023 and has since been updated on April 28th of the same year. The study seeks 16 individuals across 1 medical centre."
Answered by AI
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