Nivolumab + HuMax-IL8 for Head and Neck Cancer

(Spark2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Tanguy Seiwert, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Immunosuppressants, Corticosteroids, Antivirals, others

Disqualifiers: Autoimmune disease, Uncontrolled infection, Brain metastases, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to assess safety and feasibility of pre-operative nivolumab in combination with BMS-986253 (anti-interleukin-8) in patients with squamous cell carcinoma of head and neck (SCCHN) who will undergo surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications like corticosteroids or other immunosuppressive drugs, you may need to adjust them as the trial excludes those on high doses. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Nivolumab + HuMax-IL8 for head and neck cancer?

Research shows that Nivolumab, a part of the treatment, has been effective in improving survival rates for patients with recurrent or metastatic head and neck cancer, especially when previous treatments have failed. In clinical trials, Nivolumab demonstrated favorable response rates and improved overall survival compared to standard chemotherapy. ^{1 2 3 4 5}

Is the combination of Nivolumab and HuMax-IL8 safe for humans?

Nivolumab has been used in clinical trials for head and neck cancer and has shown favorable response rates with no unexpected immune-related toxicities. However, it can be associated with immune-related adverse effects, which are side effects that occur when the immune system attacks normal cells in the body. ^{1 3 4 6 7}

How is the drug Nivolumab + HuMax-IL8 unique for head and neck cancer?

Nivolumab is an immunotherapy drug that targets the PD-1 pathway, helping the immune system attack cancer cells, and has shown improved survival rates in head and neck cancer compared to traditional chemotherapy. The combination with HuMax-IL8, which is not detailed in the provided research, suggests a novel approach potentially enhancing the immune response or targeting additional pathways, making it different from existing treatments. ^{1 4 5 8 9}

Research Team

Tanguy Seiwert, M.D.

Principal Investigator

Johns Hopkins University/Sidney Kimmel Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I have an autoimmune disease, but it's controlled or unlikely to flare without a trigger.

My liver function tests are normal, and I'm not on antiviral medication.

I am not pregnant or nursing.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive pre-operative nivolumab in combination with BMS-986253

4 weeks

Surgery

Participants undergo surgical resection of the tumor

Follow-up

Participants are monitored for safety and effectiveness after treatment

100 days

Long-term Follow-up

Participants are monitored for relapse-free survival and overall survival

Up to 5 years

Treatment Details

Interventions

• Cabiralizumab (Monoclonal Antibodies)
• HuMax-IL8 (Monoclonal Antibodies)
• Nivolumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Cohort 2 Experimental Treatment 2 Interventions

Nivolumab (240 mg) + HuMax/BMS-986253 (3600 mg) will be administered as an IV infusion.

Group II: Cohort 1 Experimental Treatment 2 Interventions

Nivolumab (240 mg) + HuMax/BMS-986253 (2400 mg) will be administered as an IV infusion.

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University Baltimore, MD

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Patients Recruited

33,600+

Bristol-Myers Squibb

Industry Sponsor

Trials

2731

Patients Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant immunotherapy prior to surgery for mucosal head and neck squamous cell carcinoma: Systematic review. Amin, N., Maroun, CA., El Asmar, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany. Singh, P., McDonald, L., Waldenberger, D., et al.[2021]

In the CheckMate 141 trial, nivolumab significantly improved overall survival (OS) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck, showing a median OS of 8.2 months for those without prior cetuximab exposure compared to 4.9 months with investigator's choice chemotherapy.

Nivolumab also demonstrated a survival benefit in patients with prior cetuximab exposure, with a median OS of 7.1 months, and had a favorable safety profile with lower rates of grade 3-4 treatment-related adverse events compared to chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use. Ferris, RL., Licitra, L., Fayette, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The genetic landscape of programmed death ligand-1 (PD-L1) alterations in head and neck cancer. Heineman, TE., Widman, A., Kuan, EC., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age. Saba, NF., Blumenschein, G., Guigay, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between immune-related adverse events and the long-term outcomes in recurrent/metastatic head and neck squamous cell carcinoma treated with nivolumab. Matsuo, M., Yasumatsu, R., Masuda, M., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab-related tracheobronchial chondritis: Extremely rare manifestation of an immune-related adverse effect. Kuba, K., Nakahira, M., Inoue, H., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Refractory Squamous Cell Cancer of the Head and Neck with Nivolumab and Ipilimumab. Schwab, KS., Kristiansen, G., Schild, HH., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab and ipilimumab in combination with radiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck. Johnson, JM., Vathiotis, IA., Harshyne, LA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant immunotherapy prior to surgery for mucosal head and neck squamous cell carcinoma: Systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The genetic landscape of programmed death ligand-1 (PD-L1) alterations in head and neck cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Relationship between immune-related adverse events and the long-term outcomes in recurrent/metastatic head and neck squamous cell carcinoma treated with nivolumab. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Nivolumab-related tracheobronchial chondritis: Extremely rare manifestation of an immune-related adverse effect. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Treatment of Refractory Squamous Cell Cancer of the Head and Neck with Nivolumab and Ipilimumab. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nivolumab and ipilimumab in combination with radiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck. [2023]