RP3 + Nivolumab Combination Therapy for Head and Neck Cancers
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you require systemic antivirals or have had a live vaccine within 28 days before starting the study treatment.
What data supports the effectiveness of the RP3 + Nivolumab combination therapy for head and neck cancers?
Research shows that the combination of paclitaxel and carboplatin, which are part of the RP3 + Nivolumab therapy, was effective in treating advanced head and neck cancer, with a 39% overall response rate in heavily pretreated patients. Additionally, previous use of nivolumab, an immune checkpoint inhibitor, is common in treating recurrent head and neck cancers, suggesting its potential benefit in combination therapies.12345
Is the RP3 + Nivolumab combination therapy generally safe for humans?
The combination of paclitaxel and carboplatin, which are part of the RP3 + Nivolumab therapy, has been studied in head and neck cancer patients and shown to have tolerable side effects, though some patients experienced significant side effects like neutropenia (low white blood cell count) and mucositis (painful inflammation of the mouth lining). Nivolumab, also part of the therapy, has been used in similar combinations and was generally well tolerated, but some patients experienced serious side effects like anemia and high blood pressure.56789
What makes the RP3 + Nivolumab combination therapy unique for head and neck cancers?
The RP3 + Nivolumab combination therapy is unique because it combines an immune checkpoint inhibitor (Nivolumab) with chemotherapy agents (Carboplatin and Paclitaxel), potentially enhancing the immune system's ability to fight cancer while directly targeting cancer cells, which is different from standard treatments that typically use chemotherapy alone or in combination with other drugs.23101112
Research Team
David Cohan, MD/FACS
Principal Investigator
Replimune Inc.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RP3 in combination with concurrent chemoradiation therapy followed by nivolumab for the LA Cohort or combined with chemotherapy and nivolumab for the R/M Cohort
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Nivolumab
- Paclitaxel
- RP3
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Replimune Inc.
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania