50 Participants Needed

Nivolumab + Chemotherapy for Nasopharyngeal Cancer

Recruiting at 53 trial locations
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
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

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or immunosuppressive medications, you may need to stop them before enrolling. It's best to discuss your specific medications with the trial team.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic corticosteroids or immunosuppressive medications, you may need to stop them before enrolling. It's best to discuss your specific medications with the trial team.

What data supports the idea that Nivolumab + Chemotherapy for Nasopharyngeal Cancer is an effective treatment?

The available research shows that combining gemcitabine with cisplatin, which are part of the chemotherapy regimen, is effective for treating nasopharyngeal cancer. Studies have shown that this combination can improve outcomes for patients with recurrent or metastatic nasopharyngeal cancer. For example, one study found that this combination had better effects compared to other treatments. However, the research provided does not specifically mention Nivolumab, so its effectiveness in combination with chemotherapy for nasopharyngeal cancer is not directly supported by the data available.12345

What data supports the effectiveness of the drug combination of gemcitabine and cisplatin for nasopharyngeal cancer?

Research shows that the combination of gemcitabine and cisplatin is effective in treating recurrent or metastatic nasopharyngeal carcinoma, with studies indicating improved outcomes compared to other chemotherapy regimens.12345

What safety data is available for Nivolumab and chemotherapy in nasopharyngeal cancer treatment?

The safety data for chemotherapy regimens involving cisplatin and gemcitabine in nasopharyngeal cancer treatment includes several studies. A Phase II trial in Taiwan evaluated the toxicity of gemcitabine plus cisplatin, while another study compared weekly and triweekly cisplatin regimens, focusing on acute toxicities. A randomized trial assessed acute toxicities of concurrent chemotherapy with docetaxel plus cisplatin, showing high incidences of grade 3 or 4 toxicities, such as mucositis and leukopenia. Another study compared cisplatin-gemcitabine with cisplatin-fluorouracil, and a separate study evaluated cisplatin and gemcitabine as induction chemotherapy, both focusing on efficacy and toxicity. These studies provide insights into the safety profile of these chemotherapy combinations, although specific data on Nivolumab in combination with these regimens is not detailed in the provided abstracts.26789

Is the combination of Nivolumab and chemotherapy safe for treating nasopharyngeal cancer?

Studies have shown that chemotherapy combinations like cisplatin and gemcitabine can cause significant side effects, including severe mucositis (painful inflammation and ulceration of the mucous membranes), leukopenia (low white blood cell count), and neutropenia (low levels of neutrophils, a type of white blood cell). These side effects were common in patients with nasopharyngeal cancer undergoing treatment, indicating that while the treatment can be effective, it also carries risks of serious side effects.26789

Is the drug combination of Cisplatin, Gemcitabine, and Nivolumab promising for nasopharyngeal cancer?

Yes, the combination of Cisplatin, Gemcitabine, and Nivolumab is promising for treating nasopharyngeal cancer. Studies show that using Nivolumab with Gemcitabine can be effective for patients who did not respond to previous treatments. This combination could improve treatment results for this type of cancer.410111213

How is the drug combination of Nivolumab, Cisplatin, and Gemcitabine unique for treating nasopharyngeal cancer?

This treatment is unique because it combines Nivolumab, an immune system booster, with chemotherapy drugs Cisplatin and Gemcitabine, potentially enhancing effectiveness against nasopharyngeal cancer compared to using chemotherapy alone.410111213

What is the purpose of this trial?

This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.

Research Team

RD

Robyn D Gartrell

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for individuals up to 21 years old with newly diagnosed stage II-IV nasopharyngeal carcinoma. Participants need a certain level of physical health (Lansky or Karnofsky score ≥60%), adequate platelet count, and normal kidney function. It's recommended but not required to provide tumor tissue for research.

Inclusion Criteria

I am 21 years old or younger.
My kidney function, measured by creatinine clearance or GFR, is normal or near normal.
My bilirubin levels are within the normal range for my age.
See 11 more

Exclusion Criteria

All patients and/or their parents or legal guardians must sign a written informed consent
I have had radiation therapy to my head or neck.
I am a man who can father a child and agree to use contraception.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Induction Therapy

Patients receive nivolumab, gemcitabine, and cisplatin intravenously over specified durations. Treatment repeats every 21 days for 3 cycles.

9 weeks
3 visits (in-person)

Consolidation Therapy

Patients receive nivolumab and cisplatin intravenously, with concurrent radiation therapy. Treatment repeats every 21 days for 3 cycles.

9 weeks
3 visits (in-person)

Maintenance Therapy

Patients receive nivolumab intravenously. Treatment repeats every 28 days for 6 cycles.

24 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

5 years
Every 3 months for 12 months, every 6 months until 24 months, then yearly

Treatment Details

Interventions

  • Cisplatin
  • Gemcitabine
  • Nivolumab
  • Radiation Therapy
Trial Overview The study tests the effectiveness of Nivolumab combined with chemotherapy drugs Gemcitabine and Cisplatin, plus radiation therapy in treating nasopharyngeal cancer. The goal is to see if this combination helps the immune system fight cancer better.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, gemcitabine, cisplatin, radiattion)Experimental Treatment17 Interventions
See Detailed Description

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
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
🇺🇸
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
🇨🇦
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
🇯🇵
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?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 235 patients with advanced nasopharyngeal carcinoma, the sequential chemotherapy regimen of gemcitabine plus cisplatin (GP) showed significantly better local control rates (96.3%) compared to cisplatin plus fluorouracil (PF) (84.1%), although overall survival rates were similar between the two groups (84.2% for GP vs. 74.4% for PF).
The GP regimen was particularly beneficial for patients classified as T1-3 and those with stage III disease, while both treatment groups experienced low incidences of severe late toxicities, primarily xerostomia and hearing impairment.
Comparing Long-Term Survival and Late Toxicities of Different Sequential Chemotherapy Regimens with Intensity-Modulated Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma.Wu, M., Ou, D., Hu, C., et al.[2021]
In a Phase II trial involving 52 patients with recurrent or metastatic nasopharyngeal carcinoma, the combination of gemcitabine and cisplatin showed a response rate of 51.9%, indicating it is an effective first-line chemotherapy option.
The treatment was generally well-tolerated, with a median overall survival of 14.6 months, although it did have significant side effects, particularly leucopenia in 61.6% of patients, and one treatment-related death due to severe sepsis.
Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: a multicenter prospective Phase II trial.Hsieh, JC., Hsu, CL., Ng, SH., et al.[2022]
In a phase 3 trial involving 362 patients with recurrent or metastatic nasopharyngeal carcinoma, gemcitabine plus cisplatin significantly improved median progression-free survival to 7.0 months compared to 5.6 months for fluorouracil plus cisplatin, establishing it as a more effective first-line treatment option.
While gemcitabine plus cisplatin had a higher incidence of certain severe side effects like leucopenia and neutropenia, it did not result in treatment-related deaths, indicating a manageable safety profile for this combination therapy.
Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial.Zhang, L., Huang, Y., Hong, S., et al.[2022]

References

Comparing Long-Term Survival and Late Toxicities of Different Sequential Chemotherapy Regimens with Intensity-Modulated Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma. [2021]
Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: a multicenter prospective Phase II trial. [2022]
Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. [2022]
Paclitaxel, carboplatin, and gemcitabine in metastatic nasopharyngeal carcinoma: a Phase II trial using a triplet combination. [2022]
Gemcitabine Combined with Cisplatin Has a Better Effect in the Treatment of Recurrent/Metastatic Advanced Nasopharyngeal Carcinoma. [2022]
Comparison of weekly and triweekly cisplatin regimens during concurrent chemoradiotherapy for nasopharyngeal carcinoma. [2020]
The Acute Toxicities and Efficacy of Concurrent Chemotherapy With Docetaxel Plus Cisplatin, or Docetaxel, or Cisplatin and Helical Tomotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Single-Center Phase II Trial. [2022]
Concurrent chemoradiotherapy followed by adjuvant cisplatin-gemcitabine versus cisplatin-fluorouracil chemotherapy for N2-3 nasopharyngeal carcinoma: a multicentre, open-label, randomised, controlled, phase 3 trial. [2023]
Induction chemotherapy with cisplatin and gemcitabine followed by accelerated radiotherapy and concurrent cisplatin in patients with stage IV(A-B) nasopharyngeal carcinoma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A Phase II Study of Nivolumab plus Gemcitabine in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (KCSG HN17-11). [2022]
Comparison of five cisplatin-based regimens frequently used as the first-line protocols in metastatic nasopharyngeal carcinoma. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Concurrent chemoradiotherapy with nedaplatin plus paclitaxel or fluorouracil for locoregionally advanced nasopharyngeal carcinoma: Survival and toxicity. [2015]
Metastatic nasopharyngeal carcinoma outcomes in patients on cisplatin with nolatrexed or 5-fluorouracil. [2019]
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