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Alkylating agents
RP3 + Nivolumab Combination Therapy for Head and Neck Cancers
Phase 2
Waitlist Available
Research Sponsored by Replimune 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 from screening through 60 days after last dose of rp3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
Awards & highlights
Study Summary
This trial studies a new therapy for advanced head and neck cancer, combining radiation, chemo, and immunotherapy.
Who is the study for?
This trial is for adults with advanced, inoperable head and neck squamous cell carcinomas (SCCHN), including oral cavity or throat cancers. Participants must have a measurable lesion, be willing to provide tumor samples, and have an ECOG performance status of 0-1. Exclusions include history of severe pneumonitis, allergies to study drugs, prior treatments targeting T-cell pathways, eligibility for curative surgery/radiation, certain viral infections or recent major surgery.Check my eligibility
What is being tested?
The trial studies RP3 combined with chemoradiation therapy followed by nivolumab for locally advanced cases or combined with chemotherapy and nivolumab for recurrent/metastatic cases. It's a Phase 2 study split into two cohorts based on the stage of cancer: one cohort has locoregionally advanced disease while the other has recurrent/metastatic disease.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs (like lungs causing pneumonitis), infusion-related reactions from the drug administration process itself, fatigue due to treatment burden on the body's resources, digestive issues like nausea or diarrhea from chemotherapy agents used alongside RP3.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening through 60 days after last dose of rp3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening through 60 days after last dose of rp3, or 100 days after last dose of nivolumab, or 28 days after last dose of either cisplatin, carboplatin, or paclitaxel, whichever occurs last
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
LA Cohort: Progression-free Survival
R/M Cohort: Objective Response Rate
Secondary outcome measures
LA Cohort: Complete Response Rate and Metabolic Complete Response Rate at 5-and 8-months Following of Initiation of Radiation Following of Initiation of Radiation
LA Cohort: Cumulative Incidence of Distant Metastatic Failure
LA Cohort: Cumulative Incidence of Locoregional Failure
+17 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHNExperimental Treatment3 Interventions
RP3 will be administered via direct intratumoral injection or via CT, ultrasound, or laryngoscopy guided intratumoral injection into superficial, subcutaneous (SC), or nodal lesions and into deeper lesions, including visceral lesions.
Group II: LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHNExperimental Treatment3 Interventions
RP3 will be administered via direct intratumoral injection or via CT, ultrasound, or laryngoscopy guided intratumoral injection into superficial, subcutaneous (SC), or nodal lesions and into deeper lesions, including visceral lesions.
Group III: LA Cohort: concurrent chemoradiation therapy in Patients With Locoregionally Advanced SCCHNActive Control1 Intervention
standard-of-care CCRT (defined as intensity-modulated radiation therapy [IMRT] and cisplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nivolumab
2016
Completed Phase 3
~4960
Find a Location
Who is running the clinical trial?
Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
1,335 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,514 Total Patients Enrolled
David Cohan, MD/FACSStudy DirectorReplimune Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had lung inflammation in the past that required steroids or currently have lung inflammation.You have had an allergic reaction or sensitivity to the study drug's components or a previous monoclonal antibody treatment.You have a severe infection that needs to be treated with IV antibiotics.You have had a viral infection that is not allowed in the study, as specified in the study guidelines.You have taken herbal supplements within two weeks before the start of the study.You have stage III or IV squamous cell carcinoma of the head and neck with an unknown origin, regardless of whether you smoke or have a specific protein called p16.There are additional requirements for each group of participants that will be explained in the study guidelines.You have a tumor in your nose, throat, glands or skin.You have received any previous treatment for SCCHN.You have a history of a lung disease called interstitial lung disease.You have a serious medical condition that has not been treated before and meets at least one of the following criteria:You have advanced stage lung cancer (T3 and/or N2) and either smoke currently or have a history of smoking more than 20 packs of cigarettes.You are able to receive a specific type of treatment called definitive concurrent chemoradiotherapy (CCRT) with the goal of curing your condition.
Research Study Groups:
This trial has the following groups:- Group 1: R/M Cohort:RP3 in combination with carboplatin, paclitaxel and then nivolumab in R/M SCCHN
- Group 2: LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN
- Group 3: LA Cohort: concurrent chemoradiation therapy in Patients With Locoregionally Advanced SCCHN
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.
Is there a multitude of locations administering this experiment in the city?
"USC Norris Comprehensive Cancer Center in Los Angeles, Iowa, UCLA Medicine Division of Hematology-Oncology in Iowa City, Ohio, University of Iowa Hospitals and Clinics in Cincinnati, Pennsylvania are some of the sites participating. There are a total of 34 locations across the US that are actively enrolled for this trial."
Answered by AI
Has the Federal Drug Administration sanctioned LA Cohort RP3 in tandem with CCRT and nivolumab for Locally Advanced SCCHN?
"Although there is some evidence of safety, the absence of efficacy data assigned this therapy a score of 2. LA Cohort: RP3 in combination with CCRT followed by nivolumab in Locally Advanced SCCHN was evaluated as a Phase 2 trial."
Answered by AI
What are the research objectives of this experiment?
"The primary aim of this study - to measure the Objective Response Rate in a cohort of patients, and which will be monitored from Day 1 through documented progression of disease (up to 3 years) - is augmented by additional secondary objectives. These include calculating Cumulative Incidence of Locoregional Failure, collating Patient-Reported Outcomes as determined by FACT-HNSI-22 scores, and computing Complete Response Rates."
Answered by AI
Are new participants being taken on for this experiment?
"Based on information from clinicaltrials.gov, this particular medical study is no longer recruiting subjects for participation. The trial was posted to the website on May 1st 2023 and saw its most recent update on April 14th 2023. Nevertheless, there are currently 3,524 other trials actively seeking participants at present."
Answered by AI
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