40 Participants Needed

Nivolumab + Chemoradiation for Nasopharyngeal Cancer

Recruiting at 1 trial location
AV
Overseen ByAngelica Valadez
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well nivolumab and chemoradiotherapy works in treating patients with stage II-IVB nasopharyngeal cancer. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells. Chemoradiotherapy is the combination of chemotherapy and radiation therapy and may prevent the cancer from spreading when combined with nivolumab. Giving nivolumab and chemoradiotherapy may work better in treating patients with stage II-IVB nasopharyngeal cancer.

Research Team

Sue Yom | UCSF Health

Sue S. Yom

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults (β‰₯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

I have no health conditions that prevent me from receiving immunotherapy.
My biopsy confirms I have stage II-IV nasopharyngeal cancer, not the keratinizing type.
My scans within the last 2 months show stage II to IVB nasopharyngeal cancer.
See 9 more

Exclusion Criteria

I cannot undergo radiation treatment due to health reasons.
I have an active hepatitis B or C infection.
I have not had any radiation therapy in the last 7 days.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab intravenously and undergo chemoradiotherapy with cisplatin and radiation therapy

22 weeks
11 visits (in-person) for nivolumab, 15 visits (in-person) for radiation therapy

Adjuvant Therapy

Participants receive adjuvant nivolumab treatment

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
5 visits (in-person or virtual) at 1, 3, 6, 9, and 12 months

Long-term Follow-up

Survival and disease status are collected for up to an additional 4 years

4 years

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Nivolumab + chemoradiationExperimental Treatment3 Interventions
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:

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Approved in European Union as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
πŸ‡ΊπŸ‡Έ
Approved in United States as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
πŸ‡¨πŸ‡¦
Approved in Canada as Platinol for:
  • Testicular cancer
  • Ovarian cancer
  • Cervical cancer
  • Bladder cancer
  • Head and neck cancer
  • Esophageal cancer
  • Lung cancer
  • Mesothelioma
  • Brain tumors
  • Neuroblastoma
πŸ‡―πŸ‡΅
Approved in Japan as Platinol for:
  • 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

Trials
3
Recruited
80+

National University of Singapore

Collaborator

Trials
300
Recruited
205,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

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

Trials
4
Recruited
490+
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