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RecruitingPHASE2INTERVENTIONAL

DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This study is investigating new treatment options for adults with Diffuse Large B-cell Lymphoma (DLBCL), a type of cancer that affects white blood cells. It's specifically for those whose lymphoma has returned after initial treatment (relapsed) or hasn't responded well to previous therapies (refractory). The study is in Phase 2, meaning researchers are looking closely at the safety and effectiveness of the treatments. Participants will be divided into two groups, each receiving a different combination of drugs: DPX-Survivac and pembrolizumab. One group will also receive a low dose of cyclophosphamide. The goal is to see which combination works best and whether they are safe for patients.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Enrolment target
102
Start
18 Jun 2021
Estimated completion
01 Apr 2025

What is this study about?

This study is for adults who have Diffuse Large B-cell Lymphoma, often shortened to DLBCL. This is a type of cancer that starts in white blood cells called lymphocytes. The study is for people whose DLBCL has either come back after treatment, which is called 'relapsed,' or hasn't improved with treatment, which is called 'refractory.' The main aim is to find out if new drug combinations can help these patients.

Researchers are testing two different combinations of medicines: DPX-Survivac and pembrolizumab. Some participants will also get a small, regular dose of another medicine called cyclophosphamide. The study is called 'open-label,' which means both you and your study doctor will know which treatment group you are in. This type of research helps doctors understand how well these new drug combinations work and what side effects they might have.

The hope is that these new combinations will be more effective or have fewer side effects than current treatments for DLBCL that has returned or not responded well. This research is an important step in finding better ways to help people with this type of lymphoma.

Key takeaways

  • This study investigates new drug combinations for DLBCL that has returned or not responded to standard treatments.
  • It aims to assess the safety and effectiveness of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide.
  • Participants will be assigned by chance to one of two treatment groups.
  • Regular clinic visits, tests, and tumour samples will be part of the study.
  • Taking part offers access to new treatments but also carries potential risks and benefits.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with DLBCL that has either returned or not responded to at least two previous treatments. One of these past treatments must have included certain common lymphoma medicines like an anthracycline and rituximab. You also need to be well enough to take part, meaning you can carry out most of your daily activities without much difficulty.

You would not be able to join if you have cancer that has spread to your brain or spinal cord, or if you've had major surgery, chemotherapy, or radiotherapy very recently. Also, if you've had certain other treatments like a stem cell transplant or CAR-T cell therapy within a specific recent time frame, you wouldn't be eligible. The study also cannot include you if you have certain other serious medical conditions, such as some autoimmune diseases or uncontrolled infections.

Doctors will carefully review your full medical history and current health to see if the study is a safe and suitable option for you. They will look at your blood test results and other scans to make sure you meet all the safety requirements for the treatment.

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. Has your DLBCL returned or not responded to at least two previous treatments?
  3. Have you had an anthracycline and rituximab (or similar) as part of your past treatments?
  4. Are you generally well enough to continue most of your daily activities?
  5. Have you *not* had certain major cancer treatments (like a stem cell transplant or CAR-T) very recently?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two treatment groups, like flipping a coin. You will receive doses of DPX-Survivac and pembrolizumab. If you are in one of the groups, you will also receive low-dose cyclophosphamide.

DPX-Survivac will be given as injections. You'll get two injections three weeks apart at the start, followed by smaller doses every eight weeks. Pembrolizumab will be given through a drip into your vein (IV) every three weeks. If you are in the group receiving cyclophosphamide, you'll take it as a tablet twice a day for 7 days, then have 7 days off, and this cycle will repeat throughout the study.

Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. You will also need to provide tissue samples from your tumour, both at the start and during the treatment. The total duration of your active treatment in the study and subsequent follow-up will be explained by your study doctor.

Potential risks and benefits

Taking part in this study might offer you a chance to try a new treatment combination for your DLBCL that isn't widely available yet. These treatments may help your lymphoma, but there's no guarantee they will work for everyone, and it's possible they won't help your condition. Like all medicines, these drugs can have side effects, which your study team will explain in detail. These can range from mild to more serious, and they will carefully monitor you for any changes. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

  • Compassionate Cancer Care Medical Group
    Verified postcode
    Fountain Valley, United States· Recruiting
  • Boca Raton Regional Hospital
    Verified postcode
    Boca Raton, United States· Withdrawn
  • BRCR Medical Center Inc.
    Verified postcode
    Hollywood, United States· Withdrawn
  • BRCR Medical Center Inc.
    Verified postcode
    Plantation, United States· Withdrawn
  • Comprehensive Hematology and Oncology
    Verified postcode
    St. Petersburg, United States· Withdrawn
  • Blood and Marrow Transplant Group of Georgia
    Verified postcode
    Atlanta, United States· Recruiting
  • Indiana University Health Melvin and Bren Simon Cancer Center
    Verified postcode
    Indianapolis, United States· Recruiting
  • Tulane Cancer Center Office of Clinical Research
    Verified postcode
    New Orleans, United States· Recruiting
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists
    Verified postcode
    Omaha, United States· Recruiting
  • Christus St. Vincent Regional Cancer Center
    Verified postcode
    Santa Fe, United States· Recruiting
  • Brody School of Medicine at East Carolina University
    Verified postcode
    Greenville, United States· Recruiting
  • Gabrail Cancer Center Research
    Verified postcode
    Canton, United States· Withdrawn

Common questions

What is Diffuse Large B-cell Lymphoma (DLBCL)?

DLBCL is a fast-growing cancer that starts in white blood cells called lymphocytes.

What does 'relapsed or refractory' mean?

'Relapsed' means your lymphoma has come back after treatment, and 'refractory' means it hasn't responded to previous treatments.

What is a 'Phase 2' study?

A Phase 2 study is a stage of research where doctors examine how safe the new treatment is and how well it works.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, so both you and your doctor will know which treatment group you are in.

What kind of tests will I have during the study?

You'll have regular check-ups, blood tests, and scans to monitor your health and how the treatment is working.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "DPX-Survivac and Pembrolizumab With and Without Intermittent…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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