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Monoclonal Antibodies
Nivolumab + HuMax-IL8 for Head and Neck Cancer (Spark2 Trial)
Phase 2
Recruiting
Led By Tanguy Seiwert, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist. Resection should typically be definitive but may also be done for symptomatic control e.g. in the setting of (suspected) metastatic disease with dominant local symptoms.
The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed with an HPV specific assay (testing NOT required for enrollment; can be done at an interval).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days after the last dose of study drug
Awards & highlights
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.
Who is the study for?
Adults with head and neck squamous cell carcinoma, including oral cavity or larynx cancers, who are HPV-negative or high-risk HPV-positive smokers. Candidates must be eligible for surgery, have a life expectancy of over 6 months, normal organ function, and no history of certain autoimmune diseases or prior treatments with specific immunotherapies.Check my eligibility
What is being tested?
The trial is testing the safety and feasibility of combining Nivolumab (an immune checkpoint inhibitor) with BMS-986253 (anti-interleukin-8) before surgery in patients. The goal is to target myeloid cells that can suppress the immune system's response to cancer.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting different organs, infusion-related symptoms like fever or chills, fatigue, gastrointestinal issues such as diarrhea or nausea, skin rashes, and an increased risk of infections.
Spark2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
A team of cancer specialists has approved me for surgery to remove my cancer.
Select...
My cancer is in the head or neck area, possibly caused by HPV.
Select...
My organs and bone marrow are functioning normally.
Select...
I have metastatic cancer, need surgery for it, and am expected to live 6 more months or longer.
Select...
I understand the study, its risks, and am willing to sign the consent form.
Select...
I am HPV-negative or if HPV-positive, I have a heavy smoking history.
Select...
My cancer can be measured by scans or physical exams.
Select...
I have at least one tumor that can be biopsied.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Spark2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days after the last dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days after the last dose of study drug
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of neoadjuvant Nivolumab in combination with HuMax
Safety of neoadjuvant Nivolumab in combination with HuMax
Secondary outcome measures
Immune Related Pathologic Response
Overall Survival
Pathologic Response
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Spark2 Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
Nivolumab (240 mg) + HuMax/BMS-986253 (3600 mg) will be administered as an IV infusion.
Group II: Cohort 1Experimental Treatment2 Interventions
Nivolumab (240 mg) + HuMax/BMS-986253 (2400 mg) will be administered as an IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
HuMax-IL8
2015
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,876 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,490 Total Patients Enrolled
Tanguy Seiwert, M.D.Principal InvestigatorJohns Hopkins University/Sidney Kimmel Cancer Center
5 Previous Clinical Trials
219 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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