NCT04152018

Consider joining a clinical study for adults with head and neck squamous cell carcinoma or recurrent/refractory Renal Cell Carcinoma

People with metastatic HNSCC or recurrent/refractory RCC may benefit from medicines that boost the immune system to help find and fight off cancer cells (immunotherapy). Doctors are researching how potential new immunotherapy medicines may work together to treat HNSCC and RCC more effectively.

This study is evaluating if an investigational immunotherapy is safe and effective when taken with an anti-PD-1 antibody.

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Who may participate

Joining a clinical trial is an important and personal decision. Thank you for your consideration. This study may be an option if you meet the following requirements for either type of cancer:

HNSCC

  • Diagnosed with advanced or metastatic squamous cell carcinoma head and neck cancer
  • Primary tumor is in the mouth, throat, or voice box
  • Have not received previous treatment with anti-PD-L1/PD-1 immunotherapy 

OR

RCC

  • Diagnosed with advanced or metastatic renal cell carcinoma
  • Received previous treatment with anti-PD-L1/PD-1 immunotherapy and anti-angiogenic* therapy (treatment to prevent tumors from growing their own blood vessels, such as TKI therapy) and either did not improve or improved only for a limited time

Additional requirements may apply. The study doctor will explain these to you.

Condition

Head and neck squamous cell carcinoma (HNSCC) or Renal cell carcinoma (RCC)

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18+ years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

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What to expect

If you are interested in participating, the study team will schedule a screening visit to determine if you can join the study.

The study medicine is given intravenously (injected directly into the vein) by study staff twice per treatment cycle. The other medicine be given subcutaneously (injected below the skin) once per treatment cycle. A treatment cycle is 28 days in length.  You will be asked to continue treatment cycles until your cancer gets worse or the side effects become too uncomfortable.

You will need to attend regular visits so the study team can monitor how you are responding to treatment. These visits may include physical exams, blood and urine samples, ECGs (to measure heart activity), CT and/or MRI scans, and possibly tissue samples (biopsies) of your tumor.

Length of study treatment

28-day treatment cycles

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

May vary depending on participant

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

Study visits at months 1, 3, and 4 after completing treatment

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

About the study medicine

About the study medicine

Cancer treatment that boosts the body’s immune system to help it find and fight off cancer cells is called immunotherapy. The study medicine is a type of immunotherapy designed to block a specific protein in cancer cells that allows them to avoid attack by the immune system. Doctors are evaluating if taking this study medicine in addition to a PD-L1/PD-1 inhibitor (another immunotherapy) is more effective than current treatments in treating patients with HNSCC and RCC.

Frequently asked questions

How long will I be in the study?

The length of your participation in this study will vary based on how your cancer is responding to the treatment. You may continue treatment cycles until your cancer gets worse or the side effects become too uncomfortable. You will need to check in with the study team 1 month, 3 months, and 4 months after completing your final treatment.

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What if this study is not right for me?

You can choose to leave the study at any time, for any reason. Choosing to leave the study will not affect your cancer treatment or future medical care. We encourage you to speak with your oncologist about all available treatment options.

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What are the possible side effects?

All medicines have the potential to cause unwanted side effects. The study doctor will discuss the possible risks and benefits of participating in this study with you before you choose to enroll. You can choose to leave the study at any time.

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What are my other options?

Instead of taking part in this study, you may choose to receive treatment with other medicines or therapies that have been approved to treat your type of cancer, or no treatment at all. The study doctor will discuss all your options with you and help decide what’s best for your specific situation.

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Will I be paid for taking part in this study?

You will not receive payment for taking part in this study. However, you may be reimbursed for study-related expenses like parking, meals, or travel.

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