All studies
Active not recruitingPHASE2INTERVENTIONAL

Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

This study is investigating a new treatment called RP1, both alone and in combination with an existing cancer drug, nivolumab. It's for adult patients with advanced cancers that have spread or are difficult to remove with surgery, including certain types of lung cancer, non-melanoma skin cancer, and melanoma. It also includes specific solid tumours that have a genetic feature called 'microsatellite instability-high' (MSI-H). The main goals are to see how safe RP1 is and how well it works in these cancers, especially when previous treatments haven't been successful. Researchers are looking for better ways to treat these challenging cancers.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Replimune, Inc.
Enrolment target
340
Start
20 Sep 2017
Estimated completion
01 Dec 2028

What is this study about?

This research study, called IGNYTE, is looking into a new treatment for certain advanced cancers. The treatment involves a drug named RP1, which is being tested by itself and in combination with another approved cancer drug called nivolumab. The study is particularly focused on cancers that have spread or are difficult to treat with surgery, including a type of lung cancer (non-small cell lung cancer), several types of non-melanoma skin cancer, and melanoma that has already been treated with other medicines.

The study also includes certain solid tumours that have a specific genetic marker called MSI-H (Microsatellite Instability-High). This marker means the cancer might respond differently to treatments. The main purpose of this study is to gather more information on how safe RP1 is and how effective it is in shrinking or controlling these cancers, especially when they haven't responded to previous standard treatments.

By taking part, you would be helping doctors and researchers understand if this new treatment approach could offer hope to people living with challenging cancers. The study aims to find out if combining RP1 with nivolumab is a better way to treat these conditions than current options, particularly for those whose cancer has continued to grow despite other therapies.

Key takeaways

  • This study is testing a new cancer drug (RP1) alone and with an existing one (nivolumab).
  • It's for people with advanced lung, skin, and certain other solid tumours that haven't responded to prior treatments.
  • The main goals are to check safety and see how well the treatment works.
  • You would have regular check-ups, blood tests, and scans.
  • Participation is voluntary, and you can leave the study at any time.
  • This is a Phase 2 study, meaning it's still in earlier stages of drug development.

Who may be eligible?

To join this study, you would generally need to be an adult with a good level of physical fitness, able to handle daily activities with little difficulty. Your doctors would need to be able to measure your cancer on scans, and you would need at least one area of your cancer that can be injected. We would also need to look at a sample of your cancer tissue, either from a past biopsy or a new one.

This study is for people whose cancer has already been treated with other medicines, especially a type of treatment called anti-PD1/PD-L1 therapy, and your cancer has either continued to grow or come back. This includes specific types of non-melanoma skin cancer, melanoma, non-small cell lung cancer, and certain solid tumours with the MSI-H genetic marker. You should also be expected to live for at least another three months.

However, you couldn't join if you've already had a similar virus-based treatment (oncolytic therapy). You also can't participate if you have certain past or current health issues, such as a history of severe viral infections (especially certain herpes infections), serious heart problems, or certain lung conditions. Regular use of anti-viral medications or uncontrolled spread of cancer to the brain would also prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 or older?
  2. Are you able to manage daily activities with little help (ECOG PS 0-1)?
  3. Has your advanced cancer progressed after previous immunotherapy?
  4. Do you have a measurable area of cancer that can be injected?
  5. Do you have good kidney, liver, and heart health?
  6. Have you *not* had similar virus-based cancer treatments before?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the study medication, RP1, which might be given alone or with nivolumab. These medicines are typically given as injections or infusions. You would have regular visits to the clinic for treatments, health checks, blood tests, and scans to monitor your cancer and how you're feeling. Doctors would check for any side effects and see how your body is responding to the treatment. The total duration of your participation would depend on how your body responds to the treatment and the study's protocol, but it would involve ongoing check-ups. You would also need to provide tissue samples for further analysis.

Potential risks and benefits

Participating in this study might offer a chance for your cancer to respond to a new treatment, especially if previous therapies haven't worked well. However, like all medical treatments, there are potential risks and side effects from the study drugs, which your doctor will explain in detail. These could include reactions related to the viral therapy or immune-related side effects from nivolumab. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (51)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Birmingham Alabama
    Verified postcode
    Birmingham, United States
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States
  • Mayo Clinic
    Verified postcode
    Phoenix, United States
  • Carti Cancer Center
    Verified postcode
    Little Rock, United States
  • UC San Diego
    Verified postcode
    La Jolla, United States
  • University of Southern California
    Verified postcode
    Los Angeles, United States
  • UCLA
    Verified postcode
    Los Angeles, United States
  • University of California, Irvine
    Verified postcode
    Orange, United States
  • University of California- San Francisco
    Verified postcode
    San Francisco, United States
  • Sylvester Comprehensive Cancer Center- University of Miami
    Verified postcode
    Miami, United States
  • University of Iowa-Cancer Center Research
    Verified postcode
    Iowa City, United States
  • James Graham Brown Cancer Center- University of Louisville
    Verified postcode
    Louisville, United States

Common questions

What is RP1?

RP1 is an experimental, virus-based treatment designed to help your immune system fight cancer cells. It's not yet approved for general use.

What is nivolumab?

Nivolumab is a type of immunotherapy that helps your body's immune system recognise and attack cancer cells. It's an approved cancer treatment.

What does 'Microsatellite Instability-High (MSI-H)' mean?

MSI-H is a characteristic of some cancer cells that can be found through genetic testing. It might mean the cancer responds differently to certain treatments like immunotherapy.

What does 'anti-PD1 failed' mean?

This means that a treatment that blocks the PD1 pathway (a type of immunotherapy) was given, but the cancer continued to grow despite the treatment.

Will I get a placebo (dummy drug) in this study?

No, this study does not use a placebo. All participants will receive RP1, either alone or with nivolumab.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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