Study on RADVAX™ for Relapsed or Hard-to-Treat Non-Hodgkin Lymphoma: Phase II Trial of Pembrolizumab and Low-Dose Radiotherapy

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04827862

Provider View

This clinical trial is testing a combination of the immunotherapy drug pembrolizumab and low-dose radiotherapy to treat patients with relapsed or hard-to-treat non-Hodgkin lymphoma. The study aims to see if this combination can help control the disease.

Patient Parameters

Program Overview

This study is exploring a treatment for patients with relapsed or hard-to-treat non-Hodgkin lymphoma using pembrolizumab, an immunotherapy drug, along with low-dose radiotherapy. Patients eligible for this trial must have at least two measurable sites of the disease and be suitable for pembrolizumab treatment. Blood and tumor samples will be collected for research purposes. Pembrolizumab will be continued after radiotherapy until the disease progresses, the patient cannot tolerate the drug, or the doctor decides to stop it.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older with a confirmed diagnosis of relapsed or hard-to-treat non-Hodgkin lymphoma.
  • Men must agree to use contraception during treatment and for 120 days after the last dose.
  • Women must not be pregnant or breastfeeding and must agree to use contraception during treatment and for 120 days after the last dose.
  • Must provide written informed consent to participate.
  • Must have measurable disease based on specific medical criteria.
  • Must provide a tumor sample, either from a previous biopsy or a new one.
  • Must have a performance status indicating they are fully active or have some restrictions but can still do light work.
  • Must have adequate organ function as determined by specific tests.
  • Must have a type of non-Hodgkin lymphoma for which pembrolizumab is appropriate.
  • Must have been treated with at least two previous therapies for their lymphoma.
  • For certain types of lymphoma, must have relapsed after a stem cell transplant or not responded to it.
  • Prior CAR-T therapy is allowed but not required.
  • Must have at least two sites of measurable disease, with at least one outside the planned radiotherapy area.
  • Must be able to provide written informed consent.

Exclusion Criteria

  • Women who are pregnant or have a positive pregnancy test before starting treatment.
  • Have received certain types of immunotherapy or investigational drugs recently.
  • Have had recent radiotherapy or a live vaccine.
  • Are currently in another clinical trial or have used an investigational device recently.
  • Have an immune deficiency or are on high-dose steroids or other immunosuppressive drugs.
  • Have another active cancer or severe allergies to pembrolizumab.
  • Have an active autoimmune disease or a history of lung inflammation requiring steroids.
  • Have an active infection or a history of tuberculosis.
  • Have any condition that might interfere with the study or is not in their best interest to participate.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Have active brain metastases or have had a bone marrow transplant within the last 5 years.
  • Have a history of graft-versus-host disease or certain viral infections like HIV or hepatitis.

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