Nivolumab + Chemoradiation for Nasopharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of combining nivolumab (a type of immune therapy) with chemoradiotherapy in treating nasopharyngeal cancer, which affects the area behind the nose. Researchers hope that using nivolumab alongside standard chemotherapy (cisplatin) and radiation will more effectively prevent the cancer from spreading. Patients suitable for this trial have nasopharyngeal cancer confirmed through a biopsy and experience symptoms manageable with chemoradiation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that treatment with certain medications, including some anticancer therapies, is prohibited within 14 days prior to the trial. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining nivolumab with chemoradiotherapy may effectively treat nasopharyngeal cancer. Studies have found that patients usually tolerate this treatment combination well, meaning they generally do not experience severe side effects.
Nivolumab is a medicine that blocks cancer growth by targeting specific cells. When combined with chemoradiotherapy—a mix of chemotherapy and radiation therapy—it may help prevent cancer from spreading. Patients in these studies handled the treatment well, indicating its safety, especially for those with nasopharyngeal cancer.12345Why are researchers excited about this study treatment for nasopharyngeal cancer?
Researchers are excited about the combination of Nivolumab, cisplatin, and radiation therapy for nasopharyngeal cancer because it introduces a new mechanism of action through immunotherapy. Unlike traditional treatments, which often rely solely on chemotherapy and radiation, Nivolumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. This approach has the potential to enhance the overall effectiveness of treatment by working alongside the body's natural defenses. Additionally, the integration of Nivolumab with standard chemoradiation may improve outcomes for patients who haven't responded well to conventional therapies.
What evidence suggests that nivolumab and chemoradiotherapy might be an effective treatment for nasopharyngeal cancer?
Research has shown that nivolumab, a type of medication, has promising effects in fighting nasopharyngeal cancer, with a one-year survival rate of 75.8% in patients. This trial will evaluate the combination of nivolumab with chemoradiation, which includes cisplatin and radiation therapy. Cisplatin, a chemotherapy drug, improves outcomes and slows cancer cell growth in nasopharyngeal cancer. Radiation therapy, particularly the precise form known as intensity-modulated radiotherapy (IMRT), significantly enhances treatment results, leading to high survival rates. Combining these treatments in this trial may increase their effectiveness in treating nasopharyngeal cancer.678910
Who Is on the Research Team?
Sue S. Yom
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Adults (≥18 years) with stage II-IVB nasopharyngeal carcinoma, who can undergo radiation therapy and have no severe allergies to immunotherapy or chemotherapy. They must not have other active cancers, untreated brain metastases, recent monoclonal antibody treatment, or certain autoimmune diseases. Participants need functioning major organs and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab intravenously and undergo chemoradiotherapy with cisplatin and radiation therapy
Adjuvant Therapy
Participants receive adjuvant nivolumab treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Survival and disease status are collected for up to an additional 4 years
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Nivolumab
- Radiation Therapy
Trial Overview
The trial is testing the effectiveness of combining nivolumab (a type of immunotherapy that targets cancer cells) with chemoradiotherapy (cisplatin plus radiation therapy) in treating patients with nasopharyngeal cancer. The goal is to see if this combination works better than standard treatments alone.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sue Yom
Lead Sponsor
National University of Singapore
Collaborator
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
National University Cancer Institute, Singapore
Collaborator
Citations
Comparing the efficacy and safety of cisplatin and other ...
The results showed that some cisplatin-based neoadjuvant chemotherapy regimens improved the prognosis of patients with NPC and reduced the toxicity of ...
2.
cancertherapyadvisor.com
cancertherapyadvisor.com/news/cisplatin-sparing-regimen-nasopharyngeal-carcinoma/Cisplatin-Sparing Regimen Appears Effective for ...
The 3-year locoregional recurrence-free survival rate was 92.9% with the cisplatin-sparing regimen and 93.6% with standard therapy (HR, 1.14; 95 ...
Easing cisplatin's toll in nasopharyngeal carcinoma
In this issue of Cancer Cell, Xu et al. achieved favorable outcomes by incorporating nivolumab into standard therapy for locally advanced NPC while removing ...
The efficacy of cisplatin on nasopharyngeal carcinoma ...
Chen et al (30) demonstrated that cisplatin inhibited proliferation and promoted apoptosis in TW03 cells. Huang et al (31) also suggested that cisplatin ...
Efficacy and safety of weekly versus triweekly cisplatin ...
Multiple studies have compared the outcomes of weekly and triweekly cisplatin concurrent chemoradiotherapy (CCRT) in advanced head and neck squamous cell ...
Nivolumab combined with induction chemotherapy and ...
Nivolumab plus induction chemotherapy and radiotherapy demonstrated efficacious anti-tumor activity, low toxicity, and favorable tolerability ...
NCT06064097 | A Study Using Nivolumab, in Combination ...
This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC).
Combination of nivolumab with standard induction ...
Safety of nivolumab in ... The changing therapeutic role of chemo-radiotherapy for loco-regionally advanced nasopharyngeal carcinoma ...
Nivolumab combined with radical chemoradiotherapy ...
Nivolumab incorporated into induction chemotherapy followed by radiotherapy has a promising efficacy and low toxicity for high-risk LANPC patients.
NCT03267498 | Nivolumab + Chemoradiation in Stage II ...
This phase II trial studies how well nivolumab and chemoradiotherapy works in treating patients with stage II-IVB nasopharyngeal cancer.
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