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Active not recruitingPHASE3INTERVENTIONAL

Avelumab Program Rollover Study

This study is designed for adults with solid tumours who are already taking part in a clinical trial using a cancer medicine called avelumab. The main goal is to safely continue their treatment journey under the same plan they've been following. Researchers will carefully check for any side effects and make sure the treatment remains safe and tolerable for these participants. It's a way to provide ongoing care and closely monitor the long-term effects of avelumab for people who have been benefiting from it through previous research. This ensures a smooth continuation of their care from one study to the next.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
EMD Serono Research & Development Institute, Inc.
Enrolment target
205
Start
22 Mar 2019
Estimated completion
21 Aug 2026

What is this study about?

This research study, called the Avelumab Program Rollover Study, is for people who have been diagnosed with solid tumours. Solid tumours are growths of abnormal cells in organs like the lung, breast, or bowel, as opposed to blood-related cancers. The study focuses on a specific medicine called avelumab, which is a type of cancer treatment.

The main aim of this study is to allow people who are already receiving avelumab as part of another clinical trial to continue their treatment. It's like moving from one part of a research project to a new phase, ensuring there are no disruptions to their care.

Throughout the study, the medical team will pay close attention to how well participants tolerate avelumab and watch out for any side effects. This helps them understand the medicine's safety over a longer period, providing valuable information for all patients who might use avelumab in the future. The study ensures that individuals already benefiting from avelumab can continue to receive it safely and effectively.

Key takeaways

  • This study is for adults with solid tumours already using avelumab in another trial.
  • It allows you to continue your current avelumab treatment without interruption.
  • The main focus is to check the long-term safety and how well you tolerate the medicine.
  • You must use effective contraception if there's any risk of pregnancy.
  • You cannot join if you are pregnant, breastfeeding, or allergic to avelumab.

Who may be eligible?

This study is for adults aged 18 and over who have solid tumours and are already enrolled in, and receiving treatment with avelumab in, another specific avelumab clinical study sponsored by EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany, or Merck Serono Co., Ltd (Japan). You can also join if you've finished treatment in the previous study but are still being followed up to see how you're doing in the long term.

To be eligible, if you are still receiving treatment and there's a chance of pregnancy, you (and your male partner, if applicable) must agree to use highly effective contraception. This means birth control methods that have a very low chance of failing (less than 1% per year).

However, you cannot take part if you are pregnant or breastfeeding. Also, if you know you are highly sensitive or allergic to any ingredients in avelumab, this study would not be suitable for you. You also can't join if you were in the comparison group of the previous avelumab study (meaning you didn't receive avelumab), or if you had to leave the previous study for any reason. Your study doctor will make the final decision based on your overall health.

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 18 years old or older?
  2. Do you currently have a solid tumour?
  3. Are you already receiving avelumab treatment in another clinical study sponsored by EMD Serono/Merck?
  4. If you are still on active treatment and there's a risk of pregnancy, are you willing to use highly effective contraception?
  5. Are you NOT pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you join this study, your participation will mainly involve continuing your avelumab treatment as you have been doing in your original study. This means you will keep receiving the medicine according to the same plan. The study team will closely monitor your health, checking for any side effects and making sure the treatment continues to be suitable and safe for you. This will likely involve regular check-ups and assessments, similar to what you've experienced before, to track your progress and well-being. The total length of your participation will depend on your individual treatment plan and how long you need to continue receiving avelumab.

Potential risks and benefits

The potential benefit of joining this study is that you can continue receiving avelumab if you have been responding well to it in your previous trial, ensuring uninterrupted care. However, as with any medicine, there are potential risks, including the possibility of experiencing side effects from avelumab. These side effects should be similar to what you've already experienced or have been told about in your previous study. The research team will carefully monitor you for any problems. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (104)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • HonorHealth Research Institute
    Verified postcode
    Scottsdale, United States
  • Highlands Oncology Group
    Verified postcode
    Fayetteville, United States
  • University of California Davis Health System - Comprehensive Cancer Center
    Verified postcode
    Sacramento, United States
  • Providence Medical Foundation
    Verified postcode
    Santa Rosa, United States
  • St Joseph Heritage Healthcare
    Verified postcode
    Santa Rosa, United States
  • Norwalk Hospital - The Whittingham Cancer Center
    Verified postcode
    Norwalk, United States
  • Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast
    Verified postcode
    Port Saint Lucie, United States
  • Northwest Georgia Oncology Centers
    Verified postcode
    Marietta, United States
  • Maryland Oncology Hematology, P.A.
    Verified postcode
    Rockville, United States
  • Michigan State University
    Verified postcode
    Lansing, United States
  • Virginia Piper Cancer Institute
    Verified postcode
    Minneapolis, United States
  • Kansas City Research Institute, LLC - Phase I Unit
    Verified postcode
    Kansas City, United States

Common questions

What is avelumab?

Avelumab is a cancer medicine that helps your body's immune system fight against cancer cells.

Why is this study being done?

This study allows people already receiving avelumab in another trial to continue treatment safely and to monitor its long-term effects.

Do I have to take a new medicine?

No, you will continue with the same avelumab treatment you've already been receiving in your previous study.

What if I get pregnant during the study?

If there's a chance of pregnancy, you (and your male partner) must use very reliable birth control throughout the study. If you become pregnant, you would need to withdraw from the study.

Will I have more hospital visits than usual?

The study aims to continue your current treatment plan, so your visits should be similar to what you've been doing in your previous trial, focusing on monitoring your progress and safety.

How to find out more

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

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