Combination treatment for advanced Epstein-Barr Virus associated nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment involving gemcitabine, docetaxel, and toripalimab for patients with locoregionally advanced Epstein-Barr Virus positive nasopharyngeal carcinoma. The study aims to determine how well this treatment works compared to standard therapies. Participants will receive the investigational drugs along with concurrent chemoradiation and adjuvant treatment following chemoradiation. The trial is designed for patients who have not received prior therapy for their nasopharyngeal carcinoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
2. Prior therapy: None for NPC permitted
3. Life expectancy: 3 months at least
4. Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
5. ECOG Performance Status of 0,1, or 2
6. Age: At least 18 years old.

   CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:
7. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
8. Platelets ≥ 100,000 cells/mm3;
9. Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);

   Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows:
10. Total bilirubin ≤ 1.5 x institutional ULN;
11. AST and ALT ≤ 1.5 x institutional ULN;

    Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:
12. Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
14. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Exclusion Criteria:

1. Prior systemic anticancer treatment for NPC
2. Prior radiation to head and neck region or regions necessitating overlapping fields
3. Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
4. History of allergic reactions to any agents in this study
5. Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
6. Pregnant or breastfeeding
7. Severe, active co-morbidity, defined as follows:

   * Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
   * Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
   * Myocardial infarction within the last 6 months;
   * Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
   * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
8. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
9. Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
10. ≥ grade 2 peripheral sensory neuropathy

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: A. Dimitrios Colevas, MD — Stanford University
• Study coordinator: Elizabeth Winters
• Email: ewinters@stanford.edu
• Phone: (650) 723-6372

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment for advanced nasopharyngeal carcinoma using targeted therapy and immunotherapy.

  This study is testing a new combination of targeted therapy and immunotherapy with chemotherapy to see if it helps people with advanced nasopharyngeal cancer live longer without their disease getting worse.

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• Reducing radiation for nasopharyngeal cancer after immunotherapy and chemotherapy

  This study is testing if giving less radiation to patients with nasopharyngeal cancer who have responded well to immunotherapy and chemotherapy can help them feel better while reducing side effects.

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• Combining Toripalimab with Capecitabine for High-Risk Nasopharyngeal Carcinoma

  This study is testing if combining toripalimab with capecitabine can help high-risk nasopharyngeal cancer patients avoid cancer coming back after their initial treatment.

  Recruiting at 2 sites Phase 3 Jiangxi Provincial Cancer Hospital · Ganzhou, Jiangxi and 2 other locations · NCT06277050

• Comparing two treatments for advanced nasopharyngeal carcinoma

  This study is testing a new combination treatment for advanced nasopharyngeal cancer to see if it works better than the standard treatment.

  Recruiting Phase 3 Air Force Military Medical University, China · Xi'an, Shaanxi · NCT06026878

• Combining toripalimab with radiotherapy for treating nasopharyngeal carcinoma

  This study is testing if combining a new immunotherapy drug called toripalimab with radiotherapy can help people with nasopharyngeal cancer that has spread, and improve their chances of living longer and feeling better.

  Recruiting at 2 sites Phase 2 Xinqiao Hospital of Chongqing · Chongqing, Chongqing Municipality and 1 other locations · NCT05147844

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.