What side effects are associated with this type of intervention?

Common treatments for Oral Squamous Cell Carcinoma (OSCC) include chemoradiation therapy, chemotherapy, and immunotherapy. Chemoradiation therapy often leads to mucositis, xerostomia (dry mouth), dysphagia (difficulty swallowing), and dermatitis. Chemotherapy can cause nausea, vomiting, neutropenia (low white blood cell count), and fatigue. Immunotherapy, such as nivolumab, may result in immune-related adverse events including colitis, pneumonitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

FDA-approved treatments for Oral Squamous Cell Carcinoma (OSCC) include chemotherapeutic agents such as cisplatin and 5-fluorouracil, often used in combination with radiation therapy. Immunotherapy agents like nivolumab and pembrolizumab have also been approved for recurrent or metastatic OSCC, particularly in patients who are refractory to platinum-based chemotherapy. These treatments aim to enhance the efficacy of standard therapies, similar to the investigational approach of the RP3 trial, which combines nivolumab with chemoradiation.

What other types of research exist?

Promising novel alternatives to RP3 for Oral Squamous Cell Carcinoma patients include: 1) PARP inhibitors like olaparib for patients with BRCA or PALB2 pathogenic variants, which have shown efficacy in maintenance therapy after initial platinum-based chemotherapy. 2) Targeted therapy with erlotinib combined with adjuvant chemoradiation and chemotherapy, as studied by Fan et al. 3) Immunotherapy agents such as pembrolizumab, which has been evaluated for advanced salivary gland carcinoma and may have potential applications in OSCC.

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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

No Placebo-Only Group

Summary

This trial uses a modified virus called RP3 to treat advanced head and neck cancers that cannot be removed by surgery. The virus kills cancer cells and helps the immune system fight the cancer.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

LA Cohort: Progression-free Survival

R/M Cohort: Objective Response Rate

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Oral Squamous Cell Carcinoma (OSCC) include surgery, radiation therapy, and chemotherapy. Surgery aims to physically remove the tumor, while radiation therapy uses high-energy rays to kill or inhibit the growth of cancer cells. Chemotherapy involves drugs that target rapidly dividing cells. Investigational agents like RP3, which are often combined with standard therapies, may enhance the immune response or target specific molecular pathways to improve treatment efficacy. Understanding these mechanisms is crucial for OSCC patients as it aids in selecting the most effective treatment plan and potentially improving survival rates.

Window Studies in Squamous Cell Carcinoma of the Head and Neck: Values and Limits.Induction of ER and mitochondrial stress by the alkylphosphocholine erufosine in oral squamous cell carcinoma cells.Synthetic lethality and PARP-inhibitors in oral and head & neck cancer.