All studies
Active not recruitingPHASE3INTERVENTIONAL

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

This study is for people who are already taking part in specific Pfizer-sponsored cancer treatment studies involving Avelumab and are still seeing good results. If their original study is ending, this programme allows them to continue receiving their treatment. The aim is to ensure people who are benefiting can keep getting their medication, while also tracking their safety and how well they are doing over time. It's designed for those with various advanced cancers, including lung, ovarian, and bladder cancers, and other solid tumours. This is about providing ongoing care and monitoring for participants already receiving treatment in earlier studies.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
68
Start
29 Sep 2021
Estimated completion
30 Sep 2026

What is this study about?

Imagine you're taking part in a special medical research study for a new cancer treatment, and it's helping you. What happens when that study is planned to finish? This research programme, called a 'master protocol', is designed to provide continued care for people like you. It's for patients who are already in a Pfizer-sponsored study involving a medicine called Avelumab, and importantly, are still greatly benefiting from it. Many medical studies have a set time they plan to run, and if a patient is doing well, they don't want to stop the helpful treatment when the study ends.

This programme isn't a new study for new patients; it's an extension. It groups together several different 'parent studies' that are now closing. If you're in one of those studies and your doctor believes you're still getting significant help from the treatment, this 'continuation study' allows you to keep receiving it. It also means doctors can continue to monitor your health and safety, and see how you're doing in the long term.

The main goal is to ensure that those who are seeing good results from treatments like Avelumab for advanced cancers, including advanced lung, ovarian, or bladder cancer, can continue their treatment journey safely and effectively. It’s like a bridge that allows you to carry on with something that’s working well for you.

Key takeaways

  • This is for people currently in specific Pfizer cancer studies who are benefiting.
  • It allows you to continue helpful treatment after your original study ends.
  • You'll continue to receive treatments like Avelumab for various advanced cancers.
  • Your health and safety will be monitored closely by doctors.
  • You must be willing to follow study rules, including contraception guidelines.
  • You can discuss any concerns with your medical team and can leave the study at any time.

Who may be eligible?

This study is specifically for people who are already taking part in certain Pfizer-sponsored Avelumab studies that are about to close. You can join this new programme if your current treatment is really helping you, or if you're currently in the follow-up phase of one of those studies.

You must also be willing to follow specific rules about contraception or avoiding pregnancy to take part. Also, you need to be able to come to all your scheduled appointments and follow the study's plan for treatment and other procedures.

There are a few reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, this study would not be suitable for you. Also, if your doctor or the study organisers think that joining would not be safe or appropriate for you for any medical reason, you would not be able to take part.

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. Am I currently in a Pfizer-sponsored Avelumab study?
  2. Am I still getting a lot of benefit from my treatment?
  3. Am I willing to use contraception as advised by the study?
  4. Can I attend all necessary hospital visits and follow the study instructions?
  5. Am I not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you are eligible, taking part means you'll continue to receive your current study treatment, such as Avelumab, which you were on in the original Pfizer study. You'll have regular hospital visits, just like before, so that the medical team can check how you're doing. These visits will involve health checks, tests, and discussions about any side effects you might be experiencing.

The study will also involve monitoring your safety and tracking your overall health over time. There isn't a set end date for your participation, as it continues for as long as you are benefiting from the treatment and wish to remain in the study, or until your doctor advises otherwise. You'll be given detailed information about your specific treatment plan, expected visits, and any required follow-up.

Potential risks and benefits

The potential benefit of joining this study is that you can continue to receive a treatment that has already shown to be helping you, which might improve your health or quality of life. As with any medical treatment, there are potential risks, including side effects from the medication you are taking; these would have been discussed in your original study. Your doctors will monitor you closely for any new or worsening side effects. You are always free to discuss these concerns with your medical team, and you can withdraw from the study at any time without affecting your ongoing medical care.

Locations (71)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Highlands Oncology Group, PA
    Verified postcode
    Fayetteville, United States
  • Highlands Oncology Group, PA
    Verified postcode
    Rogers, United States
  • Highlands Oncology Group, PA
    Verified postcode
    Springdale, United States
  • The Regents of the University of California
    Verified postcode
    Los Angeles, United States
  • UCLA Hematology/Oncology
    Verified postcode
    Los Angeles, United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • MSK Basking Ridge
    Verified postcode
    Basking Ridge, United States
  • MSK Monmouth
    Verified postcode
    Middletown, United States
  • MSK Bergen
    Verified postcode
    Montvale, United States
  • MSK Commack
    Verified postcode
    Commack, United States
  • MSK Westchester
    Verified postcode
    Harrison, United States
  • Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
    Verified postcode
    Long Island City, United States

Common questions

What is Avelumab?

Avelumab is a type of cancer drug that helps your body's immune system fight cancer cells.

Why is this study needed?

This study lets people who are benefiting from treatment in other Pfizer studies continue their medication when those original studies end.

Who can join this study?

Only people already in specific Pfizer Avelumab studies who are still doing well with their treatment can join.

What types of cancer are included?

It's for people with various advanced cancers, including certain lung, ovarian, and bladder cancers, and other solid tumours.

Can I join if I'm pregnant?

No, if you are pregnant or breastfeeding, you cannot join this study.

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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