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Nivolumab + HuMax-IL8 for Head and Neck Cancer (Spark2 Trial)
Spark2 Trial Summary
This trial is testing the safety and feasibility of using a combination of drugs to treat patients with squamous cell carcinoma of the head and neck.
Spark2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSpark2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Spark2 Trial Design
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Who is running the clinical trial?
Media Library
- I have an autoimmune disease, but it's controlled or unlikely to flare without a trigger.A team of cancer specialists has approved me for surgery to remove my cancer.You are expected to live for at least 6 more months.My cancer is in the head or neck area, possibly caused by HPV.My liver function tests are normal, and I'm not on antiviral medication.I am not pregnant or nursing.I am not excluded from taking cabiralizumab due to certain conditions.I have a condition that causes abnormal bleeding but I can take blood thinners.I have previously received treatments targeting the immune system.My organs and bone marrow are functioning normally.I have metastatic cancer, need surgery for it, and am expected to live 6 more months or longer.I understand the study, its risks, and am willing to sign the consent form.My brain cancer is stable, I've had treatment, and I'm not on high steroids.I have metastatic disease, need surgery for it, and am expected to live 6 more months.I have been on statins for over 3 months without any issues.My liver function tests are normal.I have another cancer, but it's either under control or not life-threatening within the next 3 years.I do not have HIV.I have or had significant muscle disorders or recent muscle injuries.I am HPV-negative or if HPV-positive, I have a heavy smoking history.I have not received any live vaccines within the last 30 days.I am currently taking statins.I am a man and will not use contraception with my female partner.I am not on high-dose steroids or other immune-weakening drugs.My cancer can be measured by scans or physical exams.I have at least one tumor that can be biopsied.I have brain metastases that are not currently under control.I am 18 years old or older.I do not have uncontrolled inflammatory bowel disease like Crohn's or ulcerative colitis.I don't have any major health issues that aren't under control.My head or neck cancer is caused by the Epstein-Barr Virus.I do not have an active hepatitis B or C infection.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Cohort 1
- Group 2: Cohort 2
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the intention of this research endeavor?
"This medical investigation, which is set to be evaluated within 100 days of the last dose, aims to assess the safety of neoadjuvant Nivolumab in combination with HuMax or Cabiralizumab. Secondary objectives consider overall survival longevity post-neoadjuvant therapy, pathologic response through total viable cell assessment, and immune related pathologic response by analysing tumor regression via resection specimen."
Has the FDA authorized Nivolumab for use in patients?
"Nivolumab was rated a 2 on the safety assessment scale, as Phase 2 trials have produced some evidence of its security but not any efficacy."
Is this trial the inaugural instance of its type?
"At the time of writing, 718 clinical trials involving Nivolumab are being conducted across 49 nations and 2354 cities. This research journey started in 2012 thanks to Ono Pharmaceutical Co. Ltd's Phase 1 & 2 drug approval stage trial with 659 participants; 254 studies have since been completed."
What other investigations have been undertaken utilizing Nivolumab?
"Currently, there are 82 Phase 3 trials and a total of 718 studies exploring Nivolumab. While Basel BE serves as the primary hub for these experiments, 40237 other locales across the globe also host research on this drug."
In what ways is Nivolumab typically employed in clinical practice?
"Nivolumab provides a therapeutic option for individuals struggling with malignant neoplasms, unresectable melanoma, or squamous cell carcinoma."
What is the aggregate number of participants in this investigation?
"Correct. Data hosted on clinicaltrials.gov validates that this medical study, which was initially uploaded to the website on April 24th 2021, is actively recruiting patients. Specifically, only 24 individuals are needed from 1 particular site for participation in the trial."
Is this research venture currently seeking out participants?
"Indeed, the records on clinicaltrials.gov demonstrate that this medical trial is actively open for recruitment. It was initially posted online on April 24th 2021 and last updated July 28th 2022; currently, it requires 24 patients from a single site to fill its ranks."
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