Are you interested in gaining access to new kidney cancer treatments? Would you like to help shape the future of kidney cancer care? If either or both of these ideas appeal to you, joining a clinical trial could be worth discussing with your oncologist (cancer doctor).

Clinical trials test new treatments to make sure they’re safe and effective for humans. These studies usually happen after a treatment shows promise in early testing. Read on to learn six key facts about clinical trials — how they work, who can join, and how they’re helping move kidney cancer care forward.

1. Clinical Trials Are Tightly Regulated for Safety

Before a new treatment, drug, or medical device can be tested in people, it must go through extensive research in laboratories and in animals. This is called preclinical testing. The U.S. Food and Drug Administration (FDA) reviews all the preclinical data for a new drug or treatment before researchers are allowed to start a clinical trial in humans.

The researchers must also explain how they’ll protect participants from unnecessary risks and follow strict clinical trial regulations. However, joining a clinical trial still comes with some risks.

Informed Consent

To help you understand the risks and benefits of a clinical trial, everyone who agrees to take part goes through a process called informed consent. The researchers running the trial will explain the study’s purpose, what to expect, and any possible risks. They’ll answer your questions and address your concerns. If you decide the trial isn’t right for you, you can always choose not to participate.

Risks and Benefits

Before you decide to join a clinical trial, it’s important to think through the potential risks and benefits.

Potential benefits might include:

• Receiving new treatments at low or no cost
• Helping advance kidney cancer research
• Gaining access to treatments that might be more effective than standard care
• Being compensated for your time and effort

Potential risks may include:

• Experiencing unknown or unexpected side effects
• Not seeing improvement in your condition
• Spending more time and effort on appointments and medical procedures

2. Clinical Trials Have Different Phases and Goals

Most clinical trials go through several phases. Each phase has a different research goal and helps researchers answer key questions. If at any point the treatment doesn’t work well or causes too many side effects, the study is stopped. This helps minimize the risk to participants. A treatment moves to the next phase only if it shows promising results.

Phase 1

This phase is usually the first test of a new treatment in people. The goal is to find the safest dose, figure out how to give the treatment (for example, by mouth or intravenously), and understand how it affects the body and cancer cells. A phase 1 trial typically enrolls 15 to 50 participants.

Phase 2

In this phase, researchers want to see if the new treatment works against the cancer being studied. They also continue to monitor side effects. Phase 2 usually involves fewer than 100 participants.

Phase 3

Hundreds of people might participate in a phase 3 trial. Now, the new treatment is compared to the current standard treatment to see if it’s better, just as effective, or not as effective.

Phase 4

This phase happens after the new treatment is approved by the FDA and made available to the public. Thousands of people might participate in a phase 4 trial, which tracks long-term safety and how the treatment performs in real-world settings.

3. Clinical Trials Have Specific Eligibility Requirements

The researchers running a clinical trial will determine who the new treatment is safest for and who might benefit the most. Each trial has certain eligibility criteria — rules that help protect participants and ensure reliable results.

To join a clinical trial, you’ll need to meet certain requirements. These might be based on your:

• Age
• Stage or type of kidney cancer
• History of previous treatments
• Test results, such as blood counts or organ function
• Other medical conditions that could affect your safety or treatment response

Your oncology team can help you understand if you’re eligible for any clinical trials based on your specific diagnosis and health history. You can also explore clinical trials listed by the National Cancer Institute and on ClinicalTrials.gov. Each listing includes details about eligibility criteria.

4. Clinical Trials May Involve Any Stage or Type of Cancer

Depending on the treatment being tested, a kidney cancer clinical trial may include participants with any stage or type of the disease. Clinical trials also have different goals, depending on where someone is in their treatment journey.

Trials for early-stage kidney cancer might test new approaches aimed at curing cancer or preventing cancer recurrence and metastasis (cancer spread). Other trials may focus on people with advanced kidney cancer (also called metastatic kidney cancer). These studies often explore ways to extend life, manage symptoms, or improve quality of life.

Before joining a clinical trial, it’s important to understand its goals and whether they align with your treatment priorities and personal health goals.

5. Clinical Trials Lead To Cutting-Edge Cancer Treatments

Nearly every new treatment option for kidney cancer is the result of successful research studies that made sure it’s safe and effective. Two important ways clinical trials are helping are through targeted treatments and immunotherapy.

Targeted Therapies

These types of drugs are designed to block specific proteins that cancer cells need to grow and spread. For example, the FDA recently approved a drug that blocks a protein called hypoxia-inducible factor-2 alpha, which is important for people with advanced clear cell renal cell carcinoma. Other studies are testing how well targeted therapies work on their own or combined with other treatments.

Immunotherapy

Immunotherapies for kidney cancer help the body’s immune system recognize and attack cancer cells. One recent study found that giving immunotherapy after surgery was helpful for people with clear cell renal cell carcinoma who were at high risk of their cancer coming back. Ongoing kidney cancer research is looking at new immunotherapy drugs and combinations, especially a group of medicines called immune checkpoint inhibitors. Clinical trials are helping researchers understand when and how these cancer drugs should be used and who might benefit the most from them.

6. Your Rights Are Protected When You Join a Clinical Trial

If you decide to join a clinical trial, you have certain rights as a participant. These rights are designed to protect you and make sure you have all the information you need, both before joining and throughout the trial.

Your rights as a clinical trial participant include:

• Informed consent — As discussed above, before you join, you’ll talk with the researchers about the trial’s goals, risks, and possible benefits.
• The right to withdraw at any time — You can leave the trial at any point, for any reason, without facing any penalty or losing access to standard care.
• Study updates — Throughout the trial, you’ll be informed of how the research is progressing, including any new risks that arise.

If you’re interested in learning more about clinical trials, talk with your oncology team. They can help you explore options and find trials that may be a good fit based on your type and stage of kidney cancer. Many clinical trials are actively enrolling participants, and you may qualify for one near you.

Talk With Others Who Understand

On MyKidneyCancerTeam, the social network for people with kidney cancer and their loved ones, members come together to ask questions, give advice, and share their stories with others who understand life with kidney cancer.

Have you or a loved one participated in a clinical trial? Would you consider joining a clinical trial? Share your experiences in the comments below, or start a conversation by posting on your Activities page.